Obsessive Compulsive Disorder
Conditions
Keywords
prospective, cohort, sertraline, long-term impact, cognition, emotional and physical development, pubertal maturation
Brief summary
To evaluate the long-term impact of treatment with sertraline on aspects of cognitive, emotional and physical development and pubertal maturation in pediatric subjects ages 6 to 16 years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive compulsive disorder.
Detailed description
Purposive sample: patients are not randomly selected, that is, he or she must meet certain inclusion criteria in order to qualify as a potential study participant.
Interventions
DRUGsertraline
Non interventional study - drug, dose, duration etc as per USPI and clinician discretion
BEHAVIORALpsychotherapy
Non-interventional study- as above
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Children age 6 to 16 (inclusive) with anxiety, depression, or obsessive-compulsive disorder, receiving treatment in outpatient setting, and who are prescribed a new prescription for sertraline to treat one of the above study-qualifying disorders or beginning psychotherapy for same.
Exclusion criteria
* Psychotic at study entry * Diagnosis of bipolar disorder * Diagnosis of schizoaffective or schizophrenia * Anorexia * Bulimia or eating disorder not otherwise specified (NOS) * Autism * Pervasive developmental disorder * High risk of suicide within 2 weeks of initiating study treatment * Significant mental retardation * Taking an antidepressant medication other than sertraline, first or second generation antipsychotic, lithium, psychostimulant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Cognitive Function Using Trails B at Month 3 | Baseline, Month 3 | Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation. |
| Change From Baseline in Weight at Month 30 | Baseline, Month 30 | Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Cognitive Function Using Trails B at Month 6 | Baseline, Month 6 | Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation. |
| Change From Baseline in Cognitive Function Using Trails B at Month 12 | Baseline, Month 12 | Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation. |
| Change From Baseline in Cognitive Function Using Trails B at Month 18 | Baseline, Month 18 | Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation. |
| Change From Baseline in Cognitive Function Using Trails B at Month 24 | Baseline, Month 24 | Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation. |
| Change From Baseline in Cognitive Function Using Trails B at Month 30 | Baseline, Month 30 | Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation. |
| Change From Baseline in Weight at Month 36 | Baseline, Month 36 | Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Cognitive Function Using Trails B at Month 36 | Baseline, Month 36 | Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation. |
| Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3 | Baseline, Month 3 | BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. |
| Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6 | Baseline, Month 6 | BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. |
| Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12 | Baseline, Month 12 | BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. |
| Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18 | Baseline, Month 18 | BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. |
| Change From Baseline in Body Mass Index (BMI) at Month 3 | Baseline, Month 3 | BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24 | Baseline, Month 24 | BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. |
| Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30 | Baseline, Month 30 | BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. |
| Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36 | Baseline, Month 36 | BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. |
| Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3 | Baseline, Month 3 | BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. |
| Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6 | Baseline, Month 6 | BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. |
| Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12 | Baseline, Month 12 | BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. |
| Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18 | Baseline, Month 18 | BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. |
| Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24 | Baseline, Month 24 | BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. |
| Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30 | Baseline, Month 30 | BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. |
| Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36 | Baseline, Month 36 | BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning. |
| Change From Baseline in Height at Month 3 | Baseline, Month 3 | Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on centers for disease control (CDC) norms for age and gender. |
| Change From Baseline in Height at Month 6 | Baseline, Month 6 | Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Height at Month 12 | Baseline, Month 12 | Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Height at Month 18 | Baseline, Month 18 | Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Height at Month 24 | Baseline, Month 24 | Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Height at Month 30 | Baseline, Month 30 | Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Height at Month 36 | Baseline, Month 36 | Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Weight at Month 3 | Baseline, Month 3 | Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Weight at Month 6 | Baseline, Month 6 | Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Weight at Month 12 | Baseline, Month 12 | Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Weight at Month 18 | Baseline, Month 18 | Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Weight at Month 24 | Baseline, Month 24 | Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Body Mass Index (BMI) at Month 6 | Baseline, Month 6 | BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Body Mass Index (BMI) at Month 12 | Baseline, Month 12 | BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Body Mass Index (BMI) at Month 18 | Baseline, Month 18 | BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Body Mass Index (BMI) at Month 24 | Baseline, Month 24 | BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Body Mass Index (BMI) at Month 30 | Baseline, Month 30 | BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Change From Baseline in Body Mass Index (BMI) at Month 36 | Baseline, Month 36 | BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender. |
| Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males | Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Month 3 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Month 6 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Month 12 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Month 18 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Month 24 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Month 30 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Month 36 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Month 3 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Month 6 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Month 12 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Month 18 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Month 24 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Month 30 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
| Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Month 36 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | CGAS was to rate the general functioning of the study participants on a numeric scale of 1 to 100, where 1= extremely impaired and 100= doing very well. |
| Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3, 6, 12, 18, 24, 30 and 36 | CGI-I scale was a 7-point scale used to rate improvement in the participant's condition (benefits). Scale range/categories: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = Not changed, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher score indicated worse condition. |
| Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3, 6, 12, 18, 24, 30 and 36 | CGI-T scale was a 7-point scale used to assess the tolerability of the study medication with respect to adverse events. Scale range/categories: 1= very high, 2= high, 3= above average, 4= average, 5= low, 6= very low, and 7= extremely low. Higher score indicated less tolerability with study medication. |
| Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3, 6, 12, 18, 24, 30 and 36 | The CGI-E was the value at which the participant's therapeutic benefit and adverse impact to the study drug intersected. Firstly clinician identified the degree of therapeutic benefit on scale range: very much improved, much improved, minimally improved, unchanged or worse. Secondly, the clinician rater identified the degree to which problems with tolerability adversely impact the participant on scale range: no adverse impact, mild adverse impact, moderate adverse impact, outweighs therapeutic effect. Finally, clinician identified in which participants benefits and adverse impacts intersected. Participants were then determined to be responders or non-responders to the study medication. |
| Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | CGI-S scale was a 7-point scale used to assess severity of illness on a range of 1 to 7; where, 1= normal, not mentally ill, 2= borderline mentally ill, 3= mildly mentally ill, 4= moderately mentally ill, 5= markedly mentally ill, 6= severely mentally ill, and 7= among the most extremely mentally. Higher score indicated worse condition. |
| Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | HoNOSCA scale had 13-sub-scales used to assess general health and social functioning. 13 sub-scales were as the following: disruptive or aggressive behavior, attention deficit hyperactivity disorder (ADHD), self-harm, substance abuse, school problems, physical illness, psychosis, physical symptoms, internalizing symptoms, peer relationships, self-care, family relationships and school attendance problems. Each sub-scale had a range of 0 (no problems) to 4 (severe problems). Scores from all 13 sub-scales were summed up to give overall possible HoNOSCA total score range of 0 to 52. Higher score indicated worse condition. |
Countries
United States
Participant flow
Recruitment details
This was a non-interventional observational study. Participants to be enrolled were of age 6 to 16 (inclusive), exposed to sertraline (with or without psychotherapy) and exposed to psychotherapy alone under real world conditions. Participants exposed and unexposed to sertraline were followed for a maximum of 3 years.
Pre-assignment details
Participants switched from 1 treatment to another throughout the study, irrespective in which arm they were enrolled. Hence, number of participants for reporting arms were different at different visits.
Participants by arm
| Arm | Count |
|---|---|
| Sertraline Participants at Baseline (Day 1) or within 45 days of enrollment, initiated treatment with sertraline in routine clinical settings according to USPI provided by their physician. | 695 |
| Other Antidepressant Use of other antidepressants at baseline was a study exclusion criterion, however, a few participants were enrolled who initiated treatment with an antidepressant. | 3 |
| Psychotherapy Participants, 1) who were not taking sertraline or who failed a trial of sertraline judged adequate in dose and duration, and 2) initiated psychosocial rather than pharmacological treatment on or within 45 days of enrollment, for the same spectrum of mental health conditions that could have been treated with a SSRI medication. | 243 |
| Total | 941 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 192 | 93 |
| Overall Study | Other | 52 | 8 |
| Overall Study | Patient/Family Moved | 28 | 3 |
| Overall Study | Reason Missing For Discontinuation | 1 | 0 |
| Overall Study | Withdrew Consent | 92 | 39 |
Baseline characteristics
| Characteristic | Sertraline | Other Antidepressant | Psychotherapy | Total |
|---|---|---|---|---|
| Age, Continuous | 12.2 years STANDARD_DEVIATION 2.9 | 14.0 years STANDARD_DEVIATION 3 | 11.0 years STANDARD_DEVIATION 2.9 | 11.9 years STANDARD_DEVIATION 2.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 73 Participants | 1 Participants | 24 Participants | 98 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 622 Participants | 2 Participants | 219 Participants | 843 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 23 Participants | 0 Participants | 2 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 66 Participants | 0 Participants | 15 Participants | 81 Participants |
| Race (NIH/OMB) More than one race | 14 Participants | 0 Participants | 13 Participants | 27 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 0 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) White | 588 Participants | 3 Participants | 208 Participants | 799 Participants |
| Sex: Female, Male Female | 405 Participants | 3 Participants | 130 Participants | 538 Participants |
| Sex: Female, Male Male | 290 Participants | 0 Participants | 113 Participants | 403 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 614 | 0 / 3 | 0 / 181 | 0 / 622 | 0 / 19 | 0 / 384 | 0 / 516 | 0 / 48 | 0 / 181 | 0 / 426 | 0 / 80 | 0 / 181 | 0 / 335 | 0 / 84 | 0 / 181 | 0 / 289 | 0 / 83 | 0 / 181 | 1 / 240 | 0 / 85 | 0 / 181 | 0 / 207 | 0 / 73 | 0 / 181 |
| other Total, other adverse events | 13 / 614 | 0 / 3 | 2 / 181 | 201 / 622 | 4 / 19 | 54 / 384 | 153 / 516 | 10 / 48 | 47 / 181 | 118 / 426 | 18 / 80 | 42 / 181 | 88 / 335 | 20 / 84 | 33 / 181 | 57 / 289 | 19 / 83 | 31 / 181 | 47 / 240 | 12 / 85 | 23 / 181 | 28 / 207 | 6 / 73 | 29 / 181 |
| serious Total, serious adverse events | 3 / 614 | 0 / 3 | 0 / 181 | 27 / 622 | 1 / 19 | 9 / 384 | 19 / 516 | 2 / 48 | 2 / 181 | 11 / 426 | 2 / 80 | 7 / 181 | 11 / 335 | 1 / 84 | 4 / 181 | 6 / 289 | 3 / 83 | 3 / 181 | 2 / 240 | 1 / 85 | 2 / 181 | 4 / 207 | 4 / 73 | 2 / 181 |
Outcome results
Primary
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time frame: Baseline, Month 12
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12 | -5.42 Z-score | Standard Deviation 10.1 |
| Other Antidepressants | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12 | -2.44 Z-score | Standard Deviation 8.2 |
| Psychotherapy | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12 | -5.01 Z-score | Standard Deviation 9.5 |
Primary
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time frame: Baseline, Month 18
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18 | -5.21 Z-score | Standard Deviation 9.9 |
| Other Antidepressants | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18 | -3.59 Z-score | Standard Deviation 9.9 |
| Psychotherapy | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18 | -4.48 Z-score | Standard Deviation 9.2 |
Primary
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time frame: Baseline, Month 24
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24 | -6.21 Z-score | Standard Deviation 11.2 |
| Other Antidepressants | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24 | -5.78 Z-score | Standard Deviation 8.8 |
| Psychotherapy | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24 | -6.05 Z-score | Standard Deviation 9.9 |
Primary
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time frame: Baseline, Month 3
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3 | Baseline | 65.15 Z-score | Standard Deviation 12 |
| Sertraline | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3 | Change at Week 3 | -3.08 Z-score | Standard Deviation 9.1 |
| Other Antidepressants | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3 | Baseline | 58.67 Z-score | Standard Deviation 4 |
| Other Antidepressants | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3 | Change at Week 3 | -1.50 Z-score | Standard Deviation 0.7 |
| Psychotherapy | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3 | Baseline | 61.88 Z-score | Standard Deviation 12.6 |
| Psychotherapy | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3 | Change at Week 3 | -2.39 Z-score | Standard Deviation 7.4 |
Primary
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time frame: Baseline, Month 30
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30 | -6.92 Z-score | Standard Deviation 10.8 |
| Other Antidepressants | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30 | -5.23 Z-score | Standard Deviation 10 |
| Psychotherapy | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30 | -6.53 Z-score | Standard Deviation 10.4 |
Primary
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time frame: Baseline, Month 36
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36 | -7.44 Z-score | Standard Deviation 11.1 |
| Other Antidepressants | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36 | -7.24 Z-score | Standard Deviation 10.6 |
| Psychotherapy | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36 | -6.22 Z-score | Standard Deviation 11.2 |
Primary
Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time frame: Baseline, Month 6
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6 | -4.06 Z-score | Standard Deviation 9.4 |
| Other Antidepressants | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6 | -3.14 Z-score | Standard Deviation 9.7 |
| Psychotherapy | Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6 | -3.62 Z-score | Standard Deviation 8.9 |
Primary
Change From Baseline in Body Mass Index (BMI) at Month 12
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 12
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Body Mass Index (BMI) at Month 12 | 0.13 Z-score | Standard Deviation 0.5 |
| Other Antidepressants | Change From Baseline in Body Mass Index (BMI) at Month 12 | 0.06 Z-score | Standard Deviation 0.6 |
| Psychotherapy | Change From Baseline in Body Mass Index (BMI) at Month 12 | 0.04 Z-score | Standard Deviation 0.6 |
Primary
Change From Baseline in Body Mass Index (BMI) at Month 18
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 18
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Body Mass Index (BMI) at Month 18 | 0.18 Z-score | Standard Deviation 0.6 |
| Other Antidepressants | Change From Baseline in Body Mass Index (BMI) at Month 18 | 0.07 Z-score | Standard Deviation 0.8 |
| Psychotherapy | Change From Baseline in Body Mass Index (BMI) at Month 18 | -0.04 Z-score | Standard Deviation 0.6 |
Primary
Change From Baseline in Body Mass Index (BMI) at Month 24
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 24
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Body Mass Index (BMI) at Month 24 | 0.17 Z-score | Standard Deviation 0.7 |
| Other Antidepressants | Change From Baseline in Body Mass Index (BMI) at Month 24 | 0.20 Z-score | Standard Deviation 0.9 |
| Psychotherapy | Change From Baseline in Body Mass Index (BMI) at Month 24 | -0.01 Z-score | Standard Deviation 0.7 |
Primary
Change From Baseline in Body Mass Index (BMI) at Month 3
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 3
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Change From Baseline in Body Mass Index (BMI) at Month 3 | Baseline | 0.48 Z-score | Standard Deviation 1.3 |
| Sertraline | Change From Baseline in Body Mass Index (BMI) at Month 3 | Change at Month 3 | 0.02 Z-score | Standard Deviation 0.3 |
| Other Antidepressants | Change From Baseline in Body Mass Index (BMI) at Month 3 | Baseline | 0.79 Z-score | Standard Deviation 0.4 |
| Other Antidepressants | Change From Baseline in Body Mass Index (BMI) at Month 3 | Change at Month 3 | -0.26 Z-score | Standard Deviation 0.2 |
| Psychotherapy | Change From Baseline in Body Mass Index (BMI) at Month 3 | Baseline | 0.27 Z-score | Standard Deviation 1.3 |
| Psychotherapy | Change From Baseline in Body Mass Index (BMI) at Month 3 | Change at Month 3 | -0.03 Z-score | Standard Deviation 0.3 |
Primary
Change From Baseline in Body Mass Index (BMI) at Month 30
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 30
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Body Mass Index (BMI) at Month 30 | 0.16 Z-score | Standard Deviation 0.8 |
| Other Antidepressants | Change From Baseline in Body Mass Index (BMI) at Month 30 | 0.15 Z-score | Standard Deviation 0.8 |
| Psychotherapy | Change From Baseline in Body Mass Index (BMI) at Month 30 | 0.03 Z-score | Standard Deviation 0.7 |
Primary
Change From Baseline in Body Mass Index (BMI) at Month 36
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 36
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Body Mass Index (BMI) at Month 36 | 0.17 Z-score | Standard Deviation 0.8 |
| Other Antidepressants | Change From Baseline in Body Mass Index (BMI) at Month 36 | 0.21 Z-score | Standard Deviation 0.9 |
| Psychotherapy | Change From Baseline in Body Mass Index (BMI) at Month 36 | 0.01 Z-score | Standard Deviation 0.7 |
Primary
Change From Baseline in Body Mass Index (BMI) at Month 6
BMI is participant's weight in kilograms divided by the square of height in meters. BMI was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw BMI measurements were norm-adjusted transformed to Z-score using formula: Z-score = actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 6
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Body Mass Index (BMI) at Month 6 | 0.04 Z-score | Standard Deviation 0.4 |
| Other Antidepressants | Change From Baseline in Body Mass Index (BMI) at Month 6 | -0.03 Z-score | Standard Deviation 0.4 |
| Psychotherapy | Change From Baseline in Body Mass Index (BMI) at Month 6 | -0.06 Z-score | Standard Deviation 0.4 |
Primary
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time frame: Baseline, Month 12
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12 | -3.12 Z-score | Standard Deviation 9.1 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12 | -1.97 Z-score | Standard Deviation 8.3 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12 | -2.81 Z-score | Standard Deviation 9 |
Primary
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time frame: Baseline, Month 18
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18 | -2.40 Z-score | Standard Deviation 9.2 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18 | -1.57 Z-score | Standard Deviation 9.9 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18 | -3.13 Z-score | Standard Deviation 8.3 |
Primary
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time frame: Baseline, Month 24
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24 | -3.37 Z-score | Standard Deviation 10 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24 | -3.14 Z-score | Standard Deviation 9 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24 | -4.16 Z-score | Standard Deviation 9.5 |
Primary
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time frame: Baseline, Month 3
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3 | Baseline | 62.93 Z-score | Standard Deviation 11.3 |
| Sertraline | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3 | Change at Week 3 | -2.29 Z-score | Standard Deviation 7.8 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3 | Baseline | 57.67 Z-score | Standard Deviation 5.5 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3 | Change at Week 3 | 4.50 Z-score | Standard Deviation 13.4 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3 | Baseline | 59.27 Z-score | Standard Deviation 13 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3 | Change at Week 3 | -1.88 Z-score | Standard Deviation 7.3 |
Primary
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time frame: Baseline, Month 30
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30 | -3.60 Z-score | Standard Deviation 11.2 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30 | -4.39 Z-score | Standard Deviation 8.7 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30 | -4.53 Z-score | Standard Deviation 10.2 |
Primary
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time frame: Baseline, Month 36
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36 | -3.96 Z-score | Standard Deviation 12.1 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36 | -3.87 Z-score | Standard Deviation 10.4 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36 | -4.62 Z-score | Standard Deviation 10.9 |
Primary
Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6
BRIEF has 86-items to measure the neurocognitive performance for 8 subscales: inhibit, shift, emotional control, initiate, working memory, plan-organize, organization of materials and monitor. These are subsumed in 2 broad factors: a behavior regulation index consisted inhibit, shift, and emotional control subscales, a metacognition index consisted working memory, initiate, plan/organize, organization of materials, and task-monitor scale. Each item had a 3-point scale (1= never, 2= sometimes, 3= often). Z-score was based on mean raw score for T-score= 50 and SD = +/- 10. (actual value raw score at T=50)/SD (mean SD where T=40,60), based on age and gender norms from BRIEF professional manual. T-score provided information of individual's scores relative to scores of respondents in the standardization sample. Lower Z- scores indicated better functioning.
Time frame: Baseline, Month 6
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6 | -2.53 Z-score | Standard Deviation 8.8 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6 | -1.54 Z-score | Standard Deviation 8.8 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6 | -2.74 Z-score | Standard Deviation 8.7 |
Primary
Change From Baseline in Cognitive Function Using Trails B at Month 12
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time frame: Baseline, Month 12
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Cognitive Function Using Trails B at Month 12 | -0.72 Z-score | Standard Deviation 2.3 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Trails B at Month 12 | -0.22 Z-score | Standard Deviation 1.4 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Trails B at Month 12 | -0.27 Z-score | Standard Deviation 2.4 |
Primary
Change From Baseline in Cognitive Function Using Trails B at Month 18
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time frame: Baseline, Month 18
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Cognitive Function Using Trails B at Month 18 | -0.57 Z-score | Standard Deviation 1.9 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Trails B at Month 18 | -0.65 Z-score | Standard Deviation 2.2 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Trails B at Month 18 | -0.22 Z-score | Standard Deviation 2.8 |
Primary
Change From Baseline in Cognitive Function Using Trails B at Month 24
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time frame: Baseline, Month 24
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Cognitive Function Using Trails B at Month 24 | -0.44 Z-score | Standard Deviation 2.2 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Trails B at Month 24 | -1.08 Z-score | Standard Deviation 1.7 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Trails B at Month 24 | -0.18 Z-score | Standard Deviation 3.4 |
Primary
Change From Baseline in Cognitive Function Using Trails B at Month 3
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time frame: Baseline, Month 3
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Change From Baseline in Cognitive Function Using Trails B at Month 3 | Baseline | 1.03 Z-score | Standard Deviation 2.3 |
| Sertraline | Change From Baseline in Cognitive Function Using Trails B at Month 3 | Change at Week 3 | -0.39 Z-score | Standard Deviation 1.6 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Trails B at Month 3 | Baseline | 1.23 Z-score | Standard Deviation 1 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Trails B at Month 3 | Change at Week 3 | -0.09 Z-score | Standard Deviation 0.5 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Trails B at Month 3 | Baseline | 0.61 Z-score | Standard Deviation 1.8 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Trails B at Month 3 | Change at Week 3 | -0.03 Z-score | Standard Deviation 2.3 |
Primary
Change From Baseline in Cognitive Function Using Trails B at Month 30
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time frame: Baseline, Month 30
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Cognitive Function Using Trails B at Month 30 | -0.74 Z-score | Standard Deviation 2.1 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Trails B at Month 30 | -0.61 Z-score | Standard Deviation 2.4 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Trails B at Month 30 | -0.18 Z-score | Standard Deviation 4.2 |
Primary
Change From Baseline in Cognitive Function Using Trails B at Month 36
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time frame: Baseline, Month 36
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Cognitive Function Using Trails B at Month 36 | -0.25 Z-score | Standard Deviation 2.9 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Trails B at Month 36 | -0.13 Z-score | Standard Deviation 3.6 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Trails B at Month 36 | -0.59 Z-score | Standard Deviation 2.6 |
Primary
Change From Baseline in Cognitive Function Using Trails B at Month 6
Trail B test is a set of shifting task, in which participants were asked to drawn a line from number 1 to letter A, then to number 2, then to letter B, then to number 3, then to letter C then so forth until they connected the circles as quickly as possible, without lifting pen or pencil from the paper. Participant was timed (maximum time limit was 300 seconds or 5 minutes) to connect the trail. If the participant made an error, and it was pointed out immediately, the participant was allowed to correct it. Errors affected the participant's score only in that the correction of errors was included in the completion time for the task. A higher number of errors was indicative of a higher cognitive deficit. Raw results were the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. Raw results based on age norms were transformed to Z-scores. Z-score = actual value minus normative value divided by standard deviation.
Time frame: Baseline, Month 6
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Cognitive Function Using Trails B at Month 6 | -0.64 Z-score | Standard Deviation 2.2 |
| Other Antidepressants | Change From Baseline in Cognitive Function Using Trails B at Month 6 | -0.65 Z-score | Standard Deviation 1 |
| Psychotherapy | Change From Baseline in Cognitive Function Using Trails B at Month 6 | -0.16 Z-score | Standard Deviation 1.9 |
Primary
Change From Baseline in Height at Month 12
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 12
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Height at Month 12 | -0.01 Z-score | Standard Deviation 0.4 |
| Other Antidepressants | Change From Baseline in Height at Month 12 | 0.06 Z-score | Standard Deviation 0.5 |
| Psychotherapy | Change From Baseline in Height at Month 12 | -0.04 Z-score | Standard Deviation 0.4 |
Primary
Change From Baseline in Height at Month 18
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 18
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Height at Month 18 | -0.03 Z-score | Standard Deviation 0.5 |
| Other Antidepressants | Change From Baseline in Height at Month 18 | 0.00 Z-score | Standard Deviation 0.5 |
| Psychotherapy | Change From Baseline in Height at Month 18 | -0.02 Z-score | Standard Deviation 0.6 |
Primary
Change From Baseline in Height at Month 24
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 24
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Height at Month 24 | 0.01 Z-score | Standard Deviation 0.5 |
| Other Antidepressants | Change From Baseline in Height at Month 24 | -0.02 Z-score | Standard Deviation 0.6 |
| Psychotherapy | Change From Baseline in Height at Month 24 | -0.02 Z-score | Standard Deviation 0.5 |
Primary
Change From Baseline in Height at Month 3
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on centers for disease control (CDC) norms for age and gender.
Time frame: Baseline, Month 3
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Change From Baseline in Height at Month 3 | Baseline | 0.31 Z-score | Standard Deviation 1.1 |
| Sertraline | Change From Baseline in Height at Month 3 | Change at Month 3 | 0.00 Z-score | Standard Deviation 0.3 |
| Other Antidepressants | Change From Baseline in Height at Month 3 | Baseline | 0.76 Z-score | Standard Deviation 1.4 |
| Other Antidepressants | Change From Baseline in Height at Month 3 | Change at Month 3 | -0.03 Z-score | Standard Deviation 0.1 |
| Psychotherapy | Change From Baseline in Height at Month 3 | Change at Month 3 | -0.01 Z-score | Standard Deviation 0.3 |
| Psychotherapy | Change From Baseline in Height at Month 3 | Baseline | 0.32 Z-score | Standard Deviation 1.1 |
Primary
Change From Baseline in Height at Month 30
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 30
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Height at Month 30 | 0.01 Z-score | Standard Deviation 0.7 |
| Other Antidepressants | Change From Baseline in Height at Month 30 | -0.10 Z-score | Standard Deviation 0.6 |
| Psychotherapy | Change From Baseline in Height at Month 30 | 0.00 Z-score | Standard Deviation 0.6 |
Primary
Change From Baseline in Height at Month 36
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 36
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Height at Month 36 | 0.00 Z-score | Standard Deviation 0.7 |
| Other Antidepressants | Change From Baseline in Height at Month 36 | -0.04 Z-score | Standard Deviation 0.7 |
| Psychotherapy | Change From Baseline in Height at Month 36 | -0.02 Z-score | Standard Deviation 0.9 |
Primary
Change From Baseline in Height at Month 6
Height was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw height measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 6
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Height at Month 6 | -0.02 Z-score | Standard Deviation 0.3 |
| Other Antidepressants | Change From Baseline in Height at Month 6 | 0.07 Z-score | Standard Deviation 0.4 |
| Psychotherapy | Change From Baseline in Height at Month 6 | 0.00 Z-score | Standard Deviation 0.4 |
Primary
Change From Baseline in Weight at Month 12
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 12
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Weight at Month 12 | 0.10 Z-score | Standard Deviation 0.4 |
| Other Antidepressants | Change From Baseline in Weight at Month 12 | 0.06 Z-score | Standard Deviation 0.5 |
| Psychotherapy | Change From Baseline in Weight at Month 12 | 0.00 Z-score | Standard Deviation 0.4 |
Primary
Change From Baseline in Weight at Month 18
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 18
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Weight at Month 18 | 0.14 Z-score | Standard Deviation 0.5 |
| Other Antidepressants | Change From Baseline in Weight at Month 18 | 0.07 Z-score | Standard Deviation 0.6 |
| Psychotherapy | Change From Baseline in Weight at Month 18 | -0.01 Z-score | Standard Deviation 0.5 |
Primary
Change From Baseline in Weight at Month 24
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 24
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Weight at Month 24 | 0.16 Z-score | Standard Deviation 0.5 |
| Other Antidepressants | Change From Baseline in Weight at Month 24 | 0.15 Z-score | Standard Deviation 0.6 |
| Psychotherapy | Change From Baseline in Weight at Month 24 | 0.00 Z-score | Standard Deviation 0.6 |
Primary
Change From Baseline in Weight at Month 3
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 3
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Change From Baseline in Weight at Month 3 | Baseline | 0.58 Z-score | Standard Deviation 1.2 |
| Sertraline | Change From Baseline in Weight at Month 3 | Change at Month 3 | 0.02 Z-score | Standard Deviation 0.2 |
| Other Antidepressants | Change From Baseline in Weight at Month 3 | Baseline | 0.88 Z-score | Standard Deviation 0.7 |
| Other Antidepressants | Change From Baseline in Weight at Month 3 | Change at Month 3 | -0.22 Z-score | Standard Deviation 0.1 |
| Psychotherapy | Change From Baseline in Weight at Month 3 | Baseline | 0.42 Z-score | Standard Deviation 1 |
| Psychotherapy | Change From Baseline in Weight at Month 3 | Change at Month 3 | -0.03 Z-score | Standard Deviation 0.2 |
Primary
Change From Baseline in Weight at Month 30
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 30
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Weight at Month 30 | 0.16 Z-score | Standard Deviation 0.6 |
| Other Antidepressants | Change From Baseline in Weight at Month 30 | 0.11 Z-score | Standard Deviation 0.6 |
| Psychotherapy | Change From Baseline in Weight at Month 30 | 0.04 Z-score | Standard Deviation 0.6 |
Primary
Change From Baseline in Weight at Month 36
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 36
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Weight at Month 36 | 0.17 Z-score | Standard Deviation 0.6 |
| Other Antidepressants | Change From Baseline in Weight at Month 36 | 0.17 Z-score | Standard Deviation 0.7 |
| Psychotherapy | Change From Baseline in Weight at Month 36 | 0.02 Z-score | Standard Deviation 0.6 |
Primary
Change From Baseline in Weight at Month 6
Weight was measured and referenced to norms according to standardized procedures from the national health and nutrition examination survey (NHANES III). Raw weight measurements were norm-adjusted transformed to Z-score using formula: Z-score= actual value minus normative value divided by standard deviation based on CDC norms for age and gender.
Time frame: Baseline, Month 6
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sertraline | Change From Baseline in Weight at Month 6 | 0.03 Z-score | Standard Deviation 0.3 |
| Other Antidepressants | Change From Baseline in Weight at Month 6 | 0.01 Z-score | Standard Deviation 0.3 |
| Psychotherapy | Change From Baseline in Weight at Month 6 | -0.05 Z-score | Standard Deviation 0.3 |
Primary
Number of Participants With Tanner Staging Evaluation at Baseline: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of female participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 4 | 146 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 3 | 61 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 1 | 81 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 2 | 40 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 5 | 73 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 3 | 0 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 1 | 1 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 2 | 0 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 4 | 1 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 5 | 1 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 5 | 17 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 4 | 28 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 1 | 39 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 3 | 25 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Baseline: All Females | Stage 2 | 21 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 12: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 12
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of female participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 4 | 71 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 3 | 31 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 1 | 27 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 2 | 27 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 5 | 62 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 3 | 5 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 1 | 5 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 2 | 2 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 4 | 11 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 5 | 12 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 5 | 15 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 4 | 24 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 1 | 9 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 3 | 12 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 12: All Females | Stage 2 | 15 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 12: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 12
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of male participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 4 | 36 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 3 | 26 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 1 | 55 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 2 | 37 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 5 | 10 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 3 | 5 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 1 | 7 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 2 | 2 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 4 | 8 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 5 | 2 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 5 | 4 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 4 | 12 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 1 | 30 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 3 | 12 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 12: All Males | Stage 2 | 11 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 18: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 18
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of female participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 1 | 17 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 4 | 57 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 3 | 22 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 5 | 59 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 2 | 14 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 3 | 2 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 1 | 4 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 2 | 2 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 4 | 14 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 5 | 18 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 5 | 21 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 4 | 31 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 1 | 9 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 3 | 13 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 18: All Females | Stage 2 | 14 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 18: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 18
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of male participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 4 | 33 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 3 | 19 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 1 | 39 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 2 | 31 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 5 | 14 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 3 | 6 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 1 | 9 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 2 | 5 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 4 | 7 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 5 | 6 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 5 | 5 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 4 | 9 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 1 | 20 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 3 | 12 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 18: All Males | Stage 2 | 11 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 24: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 24
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of female participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 4 | 49 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 3 | 16 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 1 | 13 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 2 | 15 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 5 | 58 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 3 | 1 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 1 | 2 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 2 | 3 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 4 | 11 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 5 | 20 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 5 | 21 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 4 | 24 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 1 | 8 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 3 | 13 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 24: All Females | Stage 2 | 10 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 24: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 24
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of male participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 4 | 22 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 3 | 17 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 1 | 32 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 2 | 27 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 5 | 14 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 3 | 6 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 1 | 7 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 2 | 9 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 4 | 6 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 5 | 6 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 5 | 7 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 4 | 16 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 1 | 13 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 3 | 14 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 24: All Males | Stage 2 | 12 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 30: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 30
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of female participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 4 | 34 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 3 | 15 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 1 | 10 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 2 | 15 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 5 | 58 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 3 | 1 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 1 | 1 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 2 | 2 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 4 | 8 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 5 | 21 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 5 | 35 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 4 | 29 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 1 | 3 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 3 | 8 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 30: All Females | Stage 2 | 9 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 30: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 30
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of male participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 4 | 15 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 3 | 16 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 1 | 23 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 2 | 18 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 5 | 14 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 3 | 5 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 1 | 5 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 2 | 7 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 4 | 6 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 5 | 10 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 5 | 8 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 4 | 19 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 1 | 10 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 3 | 19 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 30: All Males | Stage 2 | 8 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 36: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 36
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of female participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 4 | 32 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 3 | 9 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 1 | 9 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 2 | 9 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 5 | 61 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 3 | 7 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 1 | 0 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 2 | 2 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 4 | 7 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 5 | 14 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 5 | 44 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 4 | 25 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 1 | 2 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 3 | 8 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 36: All Females | Stage 2 | 9 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 36: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 36
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of male participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 1 | 18 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 5 | 12 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 4 | 22 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 3 | 14 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 2 | 18 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 1 | 6 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 2 | 4 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 3 | 10 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 4 | 4 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 5 | 10 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 5 | 16 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 2 | 12 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 4 | 25 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 1 | 7 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 36: All Males | Stage 3 | 15 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 3: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 3
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of female participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 4 | 108 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 3 | 47 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 1 | 59 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 2 | 37 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 5 | 72 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 3 | 0 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 1 | 1 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 2 | 0 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 4 | 0 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 5 | 1 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 5 | 13 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 4 | 24 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 1 | 30 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 3 | 14 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 3: All Females | Stage 2 | 13 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 3: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 3
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of male participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 4 | 45 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 3 | 43 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 1 | 94 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 2 | 40 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 5 | 8 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 3 | 0 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 1 | 1 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 2 | 0 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 4 | 0 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 5 | 0 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 5 | 3 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 4 | 11 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 1 | 42 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 3 | 14 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 3: All Males | Stage 2 | 10 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 6: All Females
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for females in pubertal development were assessed. Participants were evaluated for pubic hair distribution, breast development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 6
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of female participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 4 | 90 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 3 | 46 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 1 | 43 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 2 | 31 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 5 | 65 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 3 | 2 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 1 | 1 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 2 | 4 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 4 | 10 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 5 | 5 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 5 | 20 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 4 | 18 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 1 | 22 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 3 | 18 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 6: All Females | Stage 2 | 13 Participants |
Primary
Number of Participants With Tanner Staging Evaluation at Month 6: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Month 6
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of male participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 4 | 43 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 3 | 34 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 1 | 75 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 2 | 44 Participants |
| Sertraline | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 5 | 7 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 3 | 3 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 1 | 6 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 2 | 2 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 4 | 2 Participants |
| Other Antidepressants | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 5 | 1 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 5 | 2 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 4 | 14 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 1 | 36 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 3 | 14 Participants |
| Psychotherapy | Number of Participants With Tanner Staging Evaluation at Month 6: All Males | Stage 2 | 11 Participants |
Primary
Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. The physical changes for males in pubertal development (pubic hair, penis and testes) were assessed. Participants were evaluated for genital development, with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time frame: Baseline (prior to or within 45 Days of initiating treatment, if exposed) and after parental/guardian provided permission and assent
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of male participants evaluable for this outcome measure. There were no male participants in reporting arm Other Antidepressant at Baseline, hence no data collected and evaluated.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males | Stage 2 | 53 Participants |
| Sertraline | Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males | Stage 4 | 53 Participants |
| Sertraline | Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males | Stage 3 | 45 Participants |
| Sertraline | Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males | Stage 5 | 15 Participants |
| Sertraline | Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males | Stage 1 | 122 Participants |
| Psychotherapy | Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males | Stage 5 | 3 Participants |
| Psychotherapy | Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males | Stage 1 | 58 Participants |
| Psychotherapy | Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males | Stage 2 | 20 Participants |
| Psychotherapy | Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males | Stage 3 | 17 Participants |
| Psychotherapy | Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males | Stage 4 | 15 Participants |
Secondary
Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36
CGAS was to rate the general functioning of the study participants on a numeric scale of 1 to 100, where 1= extremely impaired and 100= doing very well.
Time frame: Baseline, Month 3, 6, 12, 18, 24, 30 and 36
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 36 | 13.05 Units on scale | Standard Deviation 12.9 |
| Sertraline | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | 55.80 Units on scale | Standard Deviation 10 |
| Sertraline | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 12 | 10.02 Units on scale | Standard Deviation 12.6 |
| Sertraline | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 30 | 12.37 Units on scale | Standard Deviation 13.1 |
| Sertraline | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 3 | 6.58 Units on scale | Standard Deviation 10.8 |
| Sertraline | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 18 | 10.51 Units on scale | Standard Deviation 11.7 |
| Sertraline | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 6 | 8.24 Units on scale | Standard Deviation 11.6 |
| Sertraline | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 24 | 11.29 Units on scale | Standard Deviation 12 |
| Other Antidepressants | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 6 | 1.08 Units on scale | Standard Deviation 16.5 |
| Other Antidepressants | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | 56.67 Units on scale | Standard Deviation 5.8 |
| Other Antidepressants | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 30 | 9.94 Units on scale | Standard Deviation 11.4 |
| Other Antidepressants | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 36 | 8.77 Units on scale | Standard Deviation 10.7 |
| Other Antidepressants | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 18 | 6.76 Units on scale | Standard Deviation 10.5 |
| Other Antidepressants | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 24 | 8.44 Units on scale | Standard Deviation 11.3 |
| Other Antidepressants | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 12 | 4.48 Units on scale | Standard Deviation 9.4 |
| Other Antidepressants | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 3 | -7.67 Units on scale | Standard Deviation 8.7 |
| Psychotherapy | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 36 | 15.28 Units on scale | Standard Deviation 13.6 |
| Psychotherapy | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | 59.86 Units on scale | Standard Deviation 10.9 |
| Psychotherapy | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 3 | 4.61 Units on scale | Standard Deviation 9.8 |
| Psychotherapy | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 6 | 8.23 Units on scale | Standard Deviation 11 |
| Psychotherapy | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 12 | 10.66 Units on scale | Standard Deviation 12.7 |
| Psychotherapy | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 18 | 12.46 Units on scale | Standard Deviation 12.2 |
| Psychotherapy | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 24 | 11.29 Units on scale | Standard Deviation 12.8 |
| Psychotherapy | Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 30 | 12.54 Units on scale | Standard Deviation 13 |
Secondary
Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36
HoNOSCA scale had 13-sub-scales used to assess general health and social functioning. 13 sub-scales were as the following: disruptive or aggressive behavior, attention deficit hyperactivity disorder (ADHD), self-harm, substance abuse, school problems, physical illness, psychosis, physical symptoms, internalizing symptoms, peer relationships, self-care, family relationships and school attendance problems. Each sub-scale had a range of 0 (no problems) to 4 (severe problems). Scores from all 13 sub-scales were summed up to give overall possible HoNOSCA total score range of 0 to 52. Higher score indicated worse condition.
Time frame: Baseline, Month 3, 6, 12, 18, 24, 30 and 36
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sertraline | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | 10.51 Units on scale | Standard Deviation 5.4 |
| Sertraline | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 3 | -2.75 Units on scale | Standard Deviation 4.8 |
| Sertraline | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 6 | -3.23 Units on scale | Standard Deviation 5.1 |
| Sertraline | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 12 | -3.79 Units on scale | Standard Deviation 5.5 |
| Sertraline | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 18 | -3.98 Units on scale | Standard Deviation 5.6 |
| Sertraline | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 24 | -3.96 Units on scale | Standard Deviation 5.4 |
| Sertraline | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 30 | -4.04 Units on scale | Standard Deviation 4.8 |
| Sertraline | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 36 | -4.33 Units on scale | Standard Deviation 5.3 |
| Other Antidepressants | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 6 | -0.14 Units on scale | Standard Deviation 6 |
| Other Antidepressants | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 30 | -4.75 Units on scale | Standard Deviation 4.6 |
| Other Antidepressants | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 12 | -2.46 Units on scale | Standard Deviation 5.8 |
| Other Antidepressants | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 18 | -3.53 Units on scale | Standard Deviation 5.8 |
| Other Antidepressants | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 24 | -5.07 Units on scale | Standard Deviation 6 |
| Other Antidepressants | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | 8.33 Units on scale | Standard Deviation 3.2 |
| Other Antidepressants | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 3 | 4.33 Units on scale | Standard Deviation 6.4 |
| Other Antidepressants | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 36 | -4.69 Units on scale | Standard Deviation 4.7 |
| Psychotherapy | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 6 | -3.21 Units on scale | Standard Deviation 4.7 |
| Psychotherapy | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 3 | -2.05 Units on scale | Standard Deviation 4.2 |
| Psychotherapy | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | 9.19 Units on scale | Standard Deviation 4.6 |
| Psychotherapy | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 12 | -3.88 Units on scale | Standard Deviation 4.8 |
| Psychotherapy | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 30 | -4.80 Units on scale | Standard Deviation 5.1 |
| Psychotherapy | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 24 | -4.57 Units on scale | Standard Deviation 4.7 |
| Psychotherapy | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 18 | -3.79 Units on scale | Standard Deviation 4.6 |
| Psychotherapy | Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 | Change at Month 36 | -5.30 Units on scale | Standard Deviation 5.1 |
Secondary
Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36
CGI-I scale was a 7-point scale used to rate improvement in the participant's condition (benefits). Scale range/categories: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = Not changed, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher score indicated worse condition.
Time frame: Month 3, 6, 12, 18, 24, 30 and 36
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Not Changed | 63 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Minimally Worse | 5 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Not Changed | 16 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Much Worse | 21 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Not Changed | 16 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Minimally Worse | 7 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Minimally Worse | 1 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Minimally Improved | 34 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Much Worse | 9 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Very Much Improved | 85 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Much Improved | 113 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Very Much Worse | 3 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Very Much Worse | 1 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Very Much Improved | 93 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Very Much Improved | 86 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Very Much Improved | 77 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Very Much Worse | 2 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Much Improved | 136 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Very Much Worse | 1 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Much Worse | 7 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Minimally Improved | 53 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Very Much Improved | 96 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Minimally Worse | 6 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Not Changed | 14 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Very Much Worse | 1 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Much Worse | 1 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Much Improved | 220 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Not Changed | 5 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Minimally Worse | 4 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Minimally Improved | 87 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Much Improved | 223 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Not Changed | 12 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Not Changed | 44 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Minimally Worse | 15 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Much Worse | 4 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Minimally Improved | 21 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Much Worse | 12 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Minimally Improved | 22 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Much Improved | 102 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Very Much Worse | 4 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Minimally Improved | 151 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Very Much Improved | 73 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Very Much Improved | 93 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Minimally Worse | 20 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Very Much Worse | 1 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Much Improved | 174 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Much Improved | 85 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Much Worse | 0 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Minimally Improved | 80 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Much Worse | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Minimally Worse | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Not Changed | 8 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Very Much Improved | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Much Improved | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Minimally Improved | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Not Changed | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Very Much Worse | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Very Much Improved | 2 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Much Improved | 14 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Minimally Improved | 7 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Minimally Worse | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Much Worse | 3 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Very Much Worse | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Very Much Improved | 9 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Much Improved | 19 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Minimally Improved | 20 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Not Changed | 6 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Minimally Worse | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Much Worse | 2 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Very Much Worse | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Very Much Improved | 14 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Much Improved | 34 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Minimally Improved | 11 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Not Changed | 10 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Minimally Worse | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Much Worse | 2 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Very Much Worse | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Very Much Improved | 10 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Much Improved | 39 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Minimally Improved | 10 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Not Changed | 9 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Minimally Worse | 2 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Much Worse | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Very Much Worse | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Very Much Improved | 12 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Much Improved | 41 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Minimally Improved | 8 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Not Changed | 2 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Minimally Worse | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Much Worse | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Very Much Worse | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Very Much Improved | 22 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Much Improved | 27 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Minimally Improved | 9 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Not Changed | 3 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Minimally Worse | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Much Worse | 2 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Very Much Worse | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Minimally Worse | 2 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Much Improved | 55 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Much Improved | 77 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Much Worse | 4 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Very Much Improved | 32 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Much Improved | 51 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Very Much Worse | 1 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Very Much Worse | 1 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Very Much Worse | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Very Much Improved | 43 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Much Worse | 2 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Minimally Improved | 15 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Much Improved | 63 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Minimally Worse | 2 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Very Much Improved | 17 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Minimally Improved | 23 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Minimally Improved | 48 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Much Worse | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Not Changed | 12 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Much Improved | 64 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Not Changed | 8 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Minimally Worse | 1 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Very Much Improved | 29 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Not Changed | 21 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Much Worse | 1 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Not Changed | 11 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Minimally Improved | 34 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Very Much Worse | 2 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Minimally Worse | 2 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Much Improved | 55 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Not Changed | 29 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Much Worse | 5 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Very Much Improved | 32 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Very Much Worse | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Very Much Worse | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Very Much Worse | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Much Worse | 5 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Very Much Improved | 34 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Much Worse | 6 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Minimally Worse | 1 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Much Improved | 53 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Minimally Worse | 2 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Very Much Improved | 53 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Minimally Improved | 27 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Not Changed | 18 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Minimally Improved | 69 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Not Changed | 9 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Minimally Improved | 28 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Minimally Worse | 3 Participants |
Secondary
Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36
CGI-S scale was a 7-point scale used to assess severity of illness on a range of 1 to 7; where, 1= normal, not mentally ill, 2= borderline mentally ill, 3= mildly mentally ill, 4= moderately mentally ill, 5= markedly mentally ill, 6= severely mentally ill, and 7= among the most extremely mentally. Higher score indicated worse condition.
Time frame: Baseline, Month 3, 6, 12, 18, 24, 30 and 36
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Normal, Not Mentally ill | 44 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Borderline Mentally ill | 28 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Mildly Mentally ill | 138 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Moderately Mentally ill | 377 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Markedly Mentally ill | 116 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Severely Mentally ill | 12 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Among the Most Extremely Mentally ill | 0 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Normal, Not Mentally ill | 32 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Borderline Mentally ill | 87 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Mildly Mentally ill | 163 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Moderately Mentally ill | 216 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Markedly Mentally ill | 55 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Severely Mentally ill | 3 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Among the Most Extremely Mentally ill | 0 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Normal, Not Mentally ill | 21 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Borderline Mentally ill | 93 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Mildly Mentally ill | 139 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Moderately Mentally ill | 162 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Markedly Mentally ill | 31 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Severely Mentally ill | 10 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Among the Most Extremely Mentally ill | 0 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Normal, Not Mentally ill | 42 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Borderline Mentally ill | 80 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Mildly Mentally ill | 133 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Moderately Mentally ill | 100 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Markedly Mentally ill | 22 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Severely Mentally ill | 6 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Among the Most Extremely Mentally ill | 0 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Normal, Not Mentally ill | 35 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Borderline Mentally ill | 66 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Mildly Mentally ill | 106 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Moderately Mentally ill | 76 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Markedly Mentally ill | 16 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Severely Mentally ill | 5 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Among the Most Extremely Mentally ill | 0 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Normal, Not Mentally ill | 39 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Borderline Mentally ill | 61 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Mildly Mentally ill | 100 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Moderately Mentally ill | 48 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Markedly Mentally ill | 13 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Severely Mentally ill | 2 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Among the Most Extremely Mentally ill | 0 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Normal, Not Mentally ill | 30 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Borderline Mentally ill | 58 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Mildly Mentally ill | 78 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Moderately Mentally ill | 45 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Markedly Mentally ill | 6 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Severely Mentally ill | 1 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Among the Most Extremely Mentally ill | 0 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Normal, Not Mentally ill | 36 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Borderline Mentally ill | 54 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Mildly Mentally ill | 72 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Moderately Mentally ill | 33 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Markedly Mentally ill | 7 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Severely Mentally ill | 2 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Among the Most Extremely Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Mildly Mentally ill | 17 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Normal, Not Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Moderately Mentally ill | 19 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Moderately Mentally ill | 26 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Borderline Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Borderline Mentally ill | 13 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Among the Most Extremely Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Mildly Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Among the Most Extremely Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Moderately Mentally ill | 35 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Moderately Mentally ill | 3 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Severely Mentally ill | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Mildly Mentally ill | 19 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Markedly Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Severely Mentally ill | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Borderline Mentally ill | 13 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Severely Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Markedly Mentally ill | 11 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Markedly Mentally ill | 5 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Among the Most Extremely Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Moderately Mentally ill | 33 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Borderline Mentally ill | 6 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Normal, Not Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Markedly Mentally ill | 4 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Markedly Mentally ill | 5 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Borderline Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Mildly Mentally ill | 25 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Severely Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Mildly Mentally ill | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Among the Most Extremely Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Severely Mentally ill | 3 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Moderately Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Severely Mentally ill | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Severely Mentally ill | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Markedly Mentally ill | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Moderately Mentally ill | 16 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Among the Most Extremely Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Severely Mentally ill | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Among the Most Extremely Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Markedly Mentally ill | 3 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Among the Most Extremely Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Among the Most Extremely Mentally ill | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Mildly Mentally ill | 20 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Normal, Not Mentally ill | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Normal, Not Mentally ill | 4 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Normal, Not Mentally ill | 5 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Borderline Mentally ill | 4 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Mildly Mentally ill | 13 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Normal, Not Mentally ill | 10 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Mildly Mentally ill | 9 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Borderline Mentally ill | 10 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Normal, Not Mentally ill | 2 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Moderately Mentally ill | 15 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Normal, Not Mentally ill | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Borderline Mentally ill | 13 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Markedly Mentally ill | 6 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Markedly Mentally ill | 31 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Borderline Mentally ill | 27 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Severely Mentally ill | 3 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Severely Mentally ill | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Among the Most Extremely Mentally ill | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Normal, Not Mentally ill | 32 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Mildly Mentally ill | 55 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Borderline Mentally ill | 31 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Mildly Mentally ill | 39 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Moderately Mentally ill | 29 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Moderately Mentally ill | 29 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Markedly Mentally ill | 11 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Moderately Mentally ill | 25 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Severely Mentally ill | 4 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Among the Most Extremely Mentally ill | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Markedly Mentally ill | 4 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Normal, Not Mentally ill | 26 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Among the Most Extremely Mentally ill | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Borderline Mentally ill | 29 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Mildly Mentally ill | 53 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Severely Mentally ill | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Moderately Mentally ill | 34 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Markedly Mentally ill | 7 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Severely Mentally ill | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Among the Most Extremely Mentally ill | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Among the Most Extremely Mentally ill | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Markedly Mentally ill | 6 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Normal, Not Mentally ill | 25 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Borderline Mentally ill | 29 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Normal, Not Mentally ill | 46 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Normal, Not Mentally ill | 29 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Mildly Mentally ill | 48 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Borderline Mentally ill | 17 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Mildly Mentally ill | 57 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Moderately Mentally ill | 107 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Moderately Mentally ill | 31 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Markedly Mentally ill | 14 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Severely Mentally ill | 2 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Baseline | Among the Most Extremely Mentally ill | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Markedly Mentally ill | 5 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Normal, Not Mentally ill | 18 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Borderline Mentally ill | 31 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Borderline Mentally ill | 19 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Mildly Mentally ill | 60 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Severely Mentally ill | 1 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Moderately Mentally ill | 54 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Markedly Mentally ill | 23 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Severely Mentally ill | 4 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Among the Most Extremely Mentally ill | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Among the Most Extremely Mentally ill | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Normal, Not Mentally ill | 28 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Borderline Mentally ill | 33 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Normal, Not Mentally ill | 33 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Mildly Mentally ill | 51 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Mildly Mentally ill | 55 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Moderately Mentally ill | 43 Participants |
Secondary
Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36
CGI-T scale was a 7-point scale used to assess the tolerability of the study medication with respect to adverse events. Scale range/categories: 1= very high, 2= high, 3= above average, 4= average, 5= low, 6= very low, and 7= extremely low. Higher score indicated less tolerability with study medication.
Time frame: Month 3, 6, 12, 18, 24, 30 and 36
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Above Average | 19 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Low | 0 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Low | 4 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Average | 35 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Very High | 125 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Average | 19 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Low | 11 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Extremely Low | 8 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Above Average | 9 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Very Low | 1 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Above Average | 40 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | High | 67 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Extremely Low | 0 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Extremely Low | 1 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Very High | 149 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Very High | 170 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Very High | 245 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Extremely Low | 2 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | High | 77 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Very Low | 1 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Very Low | 2 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Above Average | 16 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Very Low | 1 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Low | 5 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Average | 26 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | High | 116 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Average | 7 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Low | 2 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Above Average | 28 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Average | 69 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Average | 12 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Average | 49 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | High | 123 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Above Average | 7 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Low | 19 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Above Average | 11 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Extremely Low | 2 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Very Low | 5 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Low | 22 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | High | 55 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Extremely Low | 6 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Very High | 274 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Very High | 132 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Very High | 217 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | High | 51 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Extremely Low | 0 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | High | 84 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Very Low | 10 Participants |
| Sertraline | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Very Low | 2 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | High | 18 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Very High | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | High | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Above Average | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Average | 2 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Low | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Very Low | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Extremely Low | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Very High | 14 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | High | 4 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Above Average | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Average | 6 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Low | 2 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Very Low | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Extremely Low | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Very High | 23 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | High | 12 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Above Average | 3 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Average | 10 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Low | 4 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Very Low | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Extremely Low | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Very High | 32 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | High | 15 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Above Average | 3 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Average | 10 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Low | 3 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Very Low | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Extremely Low | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Very High | 37 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | High | 17 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Above Average | 5 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Average | 3 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Low | 3 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Very Low | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Extremely Low | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Very High | 29 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Above Average | 6 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Average | 5 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Low | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Very Low | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Extremely Low | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Very High | 35 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | High | 12 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Above Average | 3 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Average | 5 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Low | 1 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Very Low | 0 Participants |
| Other Antidepressants | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Extremely Low | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Low | 2 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Low | 4 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | High | 14 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | High | 10 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Very Low | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Very High | 30 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Average | 30 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Extremely Low | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Extremely Low | 1 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Very High | 25 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Very High | 35 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Very Low | 4 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Low | 2 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | High | 5 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Average | 23 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Above Average | 6 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Above Average | 6 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Above Average | 20 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Above Average | 18 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Average | 9 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | High | 12 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Extremely Low | 1 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Low | 1 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 6 | Very High | 33 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Average | 7 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Very Low | 1 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Average | 11 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Above Average | 7 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Extremely Low | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Low | 6 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | High | 9 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | High | 18 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Very Low | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Very High | 35 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 30 | Extremely Low | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 18 | Extremely Low | 1 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Extremely Low | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Very Low | 2 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Very High | 33 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Very Low | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Very Low | 0 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | High | 12 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Low | 4 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 36 | Very High | 32 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Above Average | 3 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Average | 14 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 3 | Low | 3 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 24 | Average | 8 Participants |
| Psychotherapy | Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Month 12 | Above Average | 12 Participants |
Secondary
Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36
The CGI-E was the value at which the participant's therapeutic benefit and adverse impact to the study drug intersected. Firstly clinician identified the degree of therapeutic benefit on scale range: very much improved, much improved, minimally improved, unchanged or worse. Secondly, the clinician rater identified the degree to which problems with tolerability adversely impact the participant on scale range: no adverse impact, mild adverse impact, moderate adverse impact, outweighs therapeutic effect. Finally, clinician identified in which participants benefits and adverse impacts intersected. Participants were then determined to be responders or non-responders to the study medication.
Time frame: Month 3, 6, 12, 18, 24, 30 and 36
Population: Analysis population included all participants in the database who had informed consent. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sertraline | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 6 | 309 Participants |
| Sertraline | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 24 | 206 Participants |
| Sertraline | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 18 | 219 Participants |
| Sertraline | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 3 | 296 Participants |
| Sertraline | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 36 | 169 Participants |
| Sertraline | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 30 | 173 Participants |
| Sertraline | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 12 | 268 Participants |
| Other Antidepressants | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 18 | 44 Participants |
| Other Antidepressants | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 3 | 1 Participants |
| Other Antidepressants | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 6 | 14 Participants |
| Other Antidepressants | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 12 | 28 Participants |
| Other Antidepressants | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 24 | 47 Participants |
| Other Antidepressants | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 30 | 52 Participants |
| Other Antidepressants | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 36 | 46 Participants |
| Psychotherapy | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 24 | 54 Participants |
| Psychotherapy | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 6 | 72 Participants |
| Psychotherapy | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 36 | 72 Participants |
| Psychotherapy | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 30 | 66 Participants |
| Psychotherapy | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 18 | 54 Participants |
| Psychotherapy | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 12 | 52 Participants |
| Psychotherapy | Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 | Responders at Month 3 | 55 Participants |