Adolescent Depression
Conditions
Brief summary
Aim 1: Assess the feasibility and acceptability of the personalized continuation treatment strategy. Aim 2: Estimate variances of primary and secondary outcomes with the continuation treatment. Aim 3: Conduct exploratory hypothesis-generating analyses to inform further development of the personalized continuation treatment strategy to be tested in a subsequent R01 proposal.
Detailed description
Male and female adolescents (ages 12-18) will be eligible for the study if they completed acute phase treatment and showed at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I \< 3)). Adolescents will enter continuation treatment having either received 12 sessions of IPT-A, 16 sessions of IPT-A, or 12 sessions of IPT-A plus fluoxetine.This is a continuation of the study An Adaptive Treatment Strategy for Adolescent Depression (PTAD) NCT01802437
Interventions
DRUGFluoxetine
Prozac (fluoxetine capsules, USP) is a selective serotonin reuptake inhibitor for oral administration.
BEHAVIORALInterpersonal Psychotherapy
Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Adolescents and parents must be English-speaking * Completed acute phase treatment (NCT01802437) and showed at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I \< 3)).
Exclusion criteria
\- Did not completed acute phase treatment (NCT01802437) or did not show at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I \< 3)) to acute phase treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children's Depression Rating Scale-Revised (CDRS-R) | 16 weeks, 32 weeks | The CDRS-R is a clinician-administered semi-structured interview designed to assess present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria. This survey contains 17 items; 3 items are rated on a scale from 0 to 5, 5 items are rated on a scale from 0 to 6, and the remaining 9 items are rated on a scale from 0 to 7. Total score is a raw sum of the 17 item scores and ranges from 0 to 108. Higher scores indicate greater depression severity. |
| Children's Global Assessment Scale (CGAS) | 16 weeks, 32 weeks | The CGAS is a numeric scale used by mental health clinicians to rate the general functioning of youths under the age of 18. Scores range from 1 to 100, with higher scores indicating better functioning. |
| Beck Depression Inventory-II (BDI-II) | 16 weeks, 32 weeks | BDI-II is a 21-item self-report multiple-choice inventory that assesses the severity of depressive symptoms reflective of DSM-IV diagnostic criteria over the prior week. Items are rated on a 4-point scale ranging from 0 to 3. Total scores are a sum of the 21 item scores ranging from 0 to 63. Higher scores indicate more severe depression symptoms. |
| Social Adjustment Scale - Self Report (SAS-SR) | 16 weeks, 32 weeks | The SAS-SR is a 42-item self report measure of role performance in the past 2 weeks. Items are rated on a 5-point scale. Total scores are calculated by summing the 42 item scores and dividing by the total number of items answered. Total scores range from 1 to 5, with higher scores indicating greater impairment of functioning. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 6 IPT-A Sessions IPT Only
Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression. | 8 |
| 6 IPT-A Sessions + Continue Current Dose of Fluoxetine IPT with continued current fluoxetine dosage
Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.
Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | 3 |
| 10 IPT-A Sessions + Begin Fluoxetine IPT with new fluoxetine use
Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.
Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | 2 |
| 10 IPT-A Sessions + Increase Dose of Fluoxetine IPT with increased dose of fluoxetine
Interpersonal Psychotherapy (IPT): Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.
Fluoxetine: Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. | 1 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | 10 IPT-A Sessions + Begin Fluoxetine | 10 IPT-A Sessions + Increase Dose of Fluoxetine | 6 IPT-A Sessions | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 2 Participants | 1 Participants | 8 Participants | 14 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15 years STANDARD_DEVIATION 1.73 | 13 years STANDARD_DEVIATION 1.41 | 16 years | 15.25 years STANDARD_DEVIATION 1.91 | 14.93 years STANDARD_DEVIATION 1.82 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 0 Participants | 7 Participants | 11 Participants |
| Region of Enrollment United States | 3 participants | 2 participants | 1 participants | 8 participants | 14 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 1 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 3 | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 8 | 0 / 3 | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 8 | 0 / 3 | 0 / 2 | 0 / 1 |
Outcome results
Primary
Beck Depression Inventory-II (BDI-II)
BDI-II is a 21-item self-report multiple-choice inventory that assesses the severity of depressive symptoms reflective of DSM-IV diagnostic criteria over the prior week. Items are rated on a 4-point scale ranging from 0 to 3. Total scores are a sum of the 21 item scores ranging from 0 to 63. Higher scores indicate more severe depression symptoms.
Time frame: 16 weeks, 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 IPT-A Sessions | Beck Depression Inventory-II (BDI-II) | 16 weeks | 7.63 score on a scale | Standard Deviation 4.27 |
| 6 IPT-A Sessions | Beck Depression Inventory-II (BDI-II) | 32 weeks | 5.86 score on a scale | Standard Deviation 3.67 |
| 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | Beck Depression Inventory-II (BDI-II) | 32 weeks | 9 score on a scale | Standard Deviation 10.82 |
| 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | Beck Depression Inventory-II (BDI-II) | 16 weeks | 11.33 score on a scale | Standard Deviation 12.66 |
| 10 IPT-A Sessions + Begin Fluoxetine | Beck Depression Inventory-II (BDI-II) | 16 weeks | 10 score on a scale | Standard Deviation 14.14 |
| 10 IPT-A Sessions + Begin Fluoxetine | Beck Depression Inventory-II (BDI-II) | 32 weeks | 1.5 score on a scale | Standard Deviation 2.12 |
| 10 IPT-A Sessions + Increase Dose of Fluoxetine | Beck Depression Inventory-II (BDI-II) | 16 weeks | NA score on a scale | — |
| 10 IPT-A Sessions + Increase Dose of Fluoxetine | Beck Depression Inventory-II (BDI-II) | 32 weeks | 41 score on a scale | — |
Primary
Children's Depression Rating Scale-Revised (CDRS-R)
The CDRS-R is a clinician-administered semi-structured interview designed to assess present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria. This survey contains 17 items; 3 items are rated on a scale from 0 to 5, 5 items are rated on a scale from 0 to 6, and the remaining 9 items are rated on a scale from 0 to 7. Total score is a raw sum of the 17 item scores and ranges from 0 to 108. Higher scores indicate greater depression severity.
Time frame: 16 weeks, 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 IPT-A Sessions | Children's Depression Rating Scale-Revised (CDRS-R) | 16 Weeks | 32.38 score on a scale | Standard Deviation 7.31 |
| 6 IPT-A Sessions | Children's Depression Rating Scale-Revised (CDRS-R) | 32 Weeks | 29 score on a scale | Standard Deviation 7.07 |
| 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | Children's Depression Rating Scale-Revised (CDRS-R) | 32 Weeks | 33.33 score on a scale | Standard Deviation 5.51 |
| 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | Children's Depression Rating Scale-Revised (CDRS-R) | 16 Weeks | 26.67 score on a scale | Standard Deviation 7.23 |
| 10 IPT-A Sessions + Begin Fluoxetine | Children's Depression Rating Scale-Revised (CDRS-R) | 16 Weeks | 51 score on a scale | Standard Deviation 4.24 |
| 10 IPT-A Sessions + Begin Fluoxetine | Children's Depression Rating Scale-Revised (CDRS-R) | 32 Weeks | 29 score on a scale | Standard Deviation 9.9 |
| 10 IPT-A Sessions + Increase Dose of Fluoxetine | Children's Depression Rating Scale-Revised (CDRS-R) | 16 Weeks | 45 score on a scale | — |
| 10 IPT-A Sessions + Increase Dose of Fluoxetine | Children's Depression Rating Scale-Revised (CDRS-R) | 32 Weeks | 51 score on a scale | — |
Primary
Children's Global Assessment Scale (CGAS)
The CGAS is a numeric scale used by mental health clinicians to rate the general functioning of youths under the age of 18. Scores range from 1 to 100, with higher scores indicating better functioning.
Time frame: 16 weeks, 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 IPT-A Sessions | Children's Global Assessment Scale (CGAS) | 16 weeks | 65 score on a scale | Standard Deviation 4 |
| 6 IPT-A Sessions | Children's Global Assessment Scale (CGAS) | 32 weeks | 72 score on a scale | Standard Deviation 10 |
| 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | Children's Global Assessment Scale (CGAS) | 32 weeks | 71 score on a scale | Standard Deviation 10 |
| 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | Children's Global Assessment Scale (CGAS) | 16 weeks | 77 score on a scale | Standard Deviation 8 |
| 10 IPT-A Sessions + Begin Fluoxetine | Children's Global Assessment Scale (CGAS) | 16 weeks | 53 score on a scale | Standard Deviation 4 |
| 10 IPT-A Sessions + Begin Fluoxetine | Children's Global Assessment Scale (CGAS) | 32 weeks | 72 score on a scale | Standard Deviation 5 |
| 10 IPT-A Sessions + Increase Dose of Fluoxetine | Children's Global Assessment Scale (CGAS) | 16 weeks | 55 score on a scale | — |
| 10 IPT-A Sessions + Increase Dose of Fluoxetine | Children's Global Assessment Scale (CGAS) | 32 weeks | 49 score on a scale | — |
Primary
Social Adjustment Scale - Self Report (SAS-SR)
The SAS-SR is a 42-item self report measure of role performance in the past 2 weeks. Items are rated on a 5-point scale. Total scores are calculated by summing the 42 item scores and dividing by the total number of items answered. Total scores range from 1 to 5, with higher scores indicating greater impairment of functioning.
Time frame: 16 weeks, 32 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 IPT-A Sessions | Social Adjustment Scale - Self Report (SAS-SR) | 16 weeks | 2.03 score on a scale | Standard Deviation 0.49 |
| 6 IPT-A Sessions | Social Adjustment Scale - Self Report (SAS-SR) | 32 weeks | 2.17 score on a scale | Standard Deviation 0.55 |
| 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | Social Adjustment Scale - Self Report (SAS-SR) | 32 weeks | 1.62 score on a scale | Standard Deviation 0.46 |
| 6 IPT-A Sessions + Continue Current Dose of Fluoxetine | Social Adjustment Scale - Self Report (SAS-SR) | 16 weeks | 2.07 score on a scale | Standard Deviation 0.22 |
| 10 IPT-A Sessions + Begin Fluoxetine | Social Adjustment Scale - Self Report (SAS-SR) | 16 weeks | 2.75 score on a scale | Standard Deviation 0.67 |
| 10 IPT-A Sessions + Begin Fluoxetine | Social Adjustment Scale - Self Report (SAS-SR) | 32 weeks | 2.18 score on a scale | Standard Deviation 0.17 |
| 10 IPT-A Sessions + Increase Dose of Fluoxetine | Social Adjustment Scale - Self Report (SAS-SR) | 16 weeks | NA score on a scale | — |
| 10 IPT-A Sessions + Increase Dose of Fluoxetine | Social Adjustment Scale - Self Report (SAS-SR) | 32 weeks | 3.09 score on a scale | — |