Depressive Disorder
Conditions
Keywords
MDD, flexible-dose, Major Depressive Disorder, paroxetine, GSK372475
Brief summary
To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the treatment of outpatients subjects with major depressive disorder to exhibit decreased pleasure, interest and energy.
Interventions
DRUGGSK372475
GSK372475 1.0-1.5 mg/day
DRUGParoxetine
Paroxetine 20-30 mg/day
OTHERPlacebo
Placebo to Match
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR criteria) * Duration of current episode is at least 12 weeks duration and less than 2 years * Symptoms of decreased energy, pleasure, and interest * Female subjects who agree to use acceptable methods of birth control throughout the study
Exclusion criteria
* Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial * Symptoms of MDE better accounted for by another diagnosis * Diagnosis of panic disorder / attacks, generalised anxiety, borderline or antisocial personality disorder, dementia, anorexia nervosa / bulimia (within 6 months of screening), bipolar disorder, schizophrenia or any other psychotic disorder(s). * Started psychotherapy within 3 months prior to the Screening * Received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening * Received psychoactive drugs within 4 weeks of randomization * Positive urine drug screen or positive blood alcohol * Suicidal risk or has had any previous suicide attempt, a family history of suicide attempt * Positive pregnancy test * History of seizure disorder, myocardial infarction (\< 1yr), or unstable medical condition * Failed to respond to an adequate course of pharmacotherapy of at least 2 different antidepressants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Randomization at the End of the Treatment Phase in the MADRS Total Score | Week 0 (Randomization) and Week 10 | The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between MADRS total score at the time point being analyzed (Week 10) to Randomization. |
| Change From Randomization at the End of the Treatment Phase (Week 10) in Bech Scale (6-item of 17-item Hamilton Depression Rating [HAMD-17] Scale) Score | Week 0 (Randomization) and Week 10 | The HAMD is a rating instrument for evaluating severity of symptoms of depression, was completed by the participant. The rating instrument used in this study was the 17-item version (HAM-D17). The Bech scale of the HAMD-17 is composed of 6 identified items out of the 17 items rated in HAMD-17 scale. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). The following symptoms were rated on a 5-point scale (0-4): depressed mood, feeling of guilt, work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). Total score ranged from 0 to 22, with 0 indicating absence of symptoms and a higher score indicating greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between Bech total score at the time point being analyzed (Week 10) to Randomization. |
| Mean Change From Randomization at the End of the Treatment Phase (Week 10) in Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Total Score | Week 0 (Randomization) and Week 10 | The IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. In order to calculate the total score of IDS-CR, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored. The total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS-CR total score at the time point being analyzed (Week 10) to Randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 0 (Randomization) up to Week 10 | The MADRS scale measures the depression level of a participant. The items of the scale include: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. The item 2 (Reported Sadness) of MADRS was scored using a scale 7-point scale of 0-6, where 0 indicates absence of symptom and higher score indicates increased severity of symptom. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between MADRS Item 2 score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization. |
| Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 0 (Randomization) up to Week 10 | The IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The item 5 (Feeling Sad) of IDS-CR was rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in score was the difference between IDS-CR Item 5 score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization. |
| Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 0 (Randomization) and Week 10 | HAMD-17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items of HAMD-17 are rated on a scale 3-point scale of 0-2 or a 5-point scale of 0-4 where 0 is absence of symptom and higher score indicate more severe symptom. Items rated on the 3-point scale include: insomnia early, middle, late; somatic symptoms gastrointestinal and general; genital symptoms; loss of weight; insight. Items rated on 5-point scale include: depressed mood; feelings of guilt; suicide; work and activities; retardation; agitation; anxiety psychic and somatic; hypochondriasis. Total score ranges from 0 to 52, where 0 indicates absence of symptom and higher scores indicates more severe symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between HAMD-17 total score at the time point being analyzed (Week 10) to Randomization. |
| Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 0 (Randomization) up to Week 10 | HAMD-17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAMD-17 are rated on a 3-point scale of 0-2 or a 5-point scale of 0-4. The item 1 (Depressed Mood) of HAMD-17 was rated the 5-point scale of 0-4, where 0 indicates absence of symptom and higher score indicates more severe symptom. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in the score was the difference between HAMD-17 Item 1 score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization. |
| Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | Week 0 (Randomization) up to Week 10 | The IDS-CR and IDS-SR is a standardized 30-item scale rated by the clinician and the participant respectively to assess the severity of a participant's depressive symptoms. The 5 items of the IDS subscale include: item 19 (general interest/involvement), item 20 (energy/fatigability), item 21 (pleasure/enjoyment), item 22 (sexual interest), item 30 (Leaden paralysis/physical energy) which assessed participant's pleasure, interest and energy. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score ranges from 0 to 15, where 0 indicates absence of symptom and higher scores indicates more severe symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS 5 Item subscale total score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization. |
| Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 0 (Randomization) up to Week 10 | The CGI-S scale measures the severity of psychiatric symptoms on a 7-point scale from 1-7. The scores indicated the following: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. The score ranged from 1-7, where 1 indicated absence of symptoms and higher score indicated greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in the score was the difference between CGI-S score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization. |
| Mean Change From Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) Total Score Over Week 10 | Week 0 (Randomization) up to Week 10 | MEI 18 item-SF questionnaire was used to measure reductions in mental energy, physical energy, and social motivation. All items use either a 7-level (0-6) or 5-level (0-4) response scale; for questions 1, 2, and 13-18, response '0' indicates lower motivation, energy and interest and responses with higher scores indicate increased motivation, energy and interest. For questions 3-12, response '0' indicates higher motivation, energy and interest and responses with higher scores indicate lower motivation, energy and interest. Items with a 5-level response scale were rescaled to 7-levels, and items were reverse-scored. Total score ranges from 0-108, where 0 indicates lower motivation, energy and interest and higher score indicates higher motivation, energy and interest. Randomization value was defined as assessment value done on Week 0. Change from Randomization in total score was difference between MEI score at individual time points being analyzed (Week 1, 4 and 10) to Randomization. |
| Mean Change From Randomization in the Changes in Sexual Functioning Questionnaire 14-item Short Form (CSFQ-14SF) Over Week 10 | Week 0 (Randomization) up to Week 10 | The CSFQ-14SF is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning. It is consisting of 14 items that measure sexual activity and sexual functioning. It measures five dimensions of sexual behavior: pleasure (1 item); desire/frequency (items 2 and 3); desire/interest (items 4, 5 and 6); arousal (items 7, 8 and 9); and orgasm (items 11, 12 and 13). Items 10 and 14 are included in the total score but not in any dimension score. Items were rated on an 5 point scale from 1 to 5. Total score ranged from 14 to 70, where higher scores indicate higher sexual functioning and lower score indicate lower sexual functioning. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in the total score was the difference between CSFQ-14SF score at the individual time points being analyzed (Week 4 and 10) to Randomization. |
| Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10 | Week 0 (Randomization) up to Week 10 | The IDS-SR is a standardized 30-item, participant rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. In order to calculate the total score of IDS-SR, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored. The total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS-SR total score at the individual time points being analyzed (Week, 1, 4 and 10) to Randomization. |
| Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 0 (Randomization) up to Week 8 | The IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. In order to calculate the total score of IDS-CR, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored. The total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS-CR total score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6 and 8) to Randomization. |
| Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 0 (Randomization) up to Week 8 | The HAMD is a rating instrument for evaluating severity of symptoms of depression, was completed by the participant. Rating instrument used in this study was the 17-item version (HAM-D17). The Bech scale of the HAMD-17 is composed of 6 identified items out of the 17 items rated in HAMD-17 scale. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). The following symptoms were rated on a 5-point scale (0-4): depressed mood, feeling of guilt, work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). Total score ranged from 0 to 22, with 0 indicating absence of symptoms and a higher score indicating greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between Bech total score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6 and 8) to randomization. |
| Percentage of Responders and Remitters of MADRS Over Week 10 | Up to Week 10 | The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The total score ranged from 0-60, where 0 indicated no depression and 60 indicated severely depressed. Responders were defined as participants who had a \>=50% reduction from randomization in MADRS total Score. Percentage change from randomization was calculated as total score at post Randomization visit minus total score at Randomization visit divided by total score at Randomization visit multiplied by 100. Remitters were defined as participants with a MADRS total score \<=11. |
| Percentage of Responders and Remitters of IDS-CR Over Week 10 | Up to Week 10 | IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score of IDS-CR calculated as : either item 11 or 12 scored; either item 13 or 14 scored; if both items scored, the highest of the items was used. Total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Responders were defined as participants who had a \>=50% reduction from randomization in IDS-CR total Score. Percentage change from randomization was calculated as total score at post Randomization visit minus total score at Randomization visit divided by total score at Randomization visit multiplied by 100. Remitters were defined as participants with a IDS-CR total score \<=14. |
| Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Up to Week 10 | HAMD-17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAMD-17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges from 0 to 52, where 0 indicates absence of symptom and higher scores indicates more severe symptoms. Responders were defined as participants who had a \>=50% reduction from randomization in HAMD-17 total Score. Percentage change from randomization was calculated as total score at post Randomization visit minus total score at Randomization visit divided by total score at Randomization visit multiplied by 100. Remitters were defined as participants with a HAMD-17 total score \<=7. |
| Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Up to Week 10 | The CGI-I scale measures the improvement of psychiatric symptoms on a 7-point scale from 1-7. The scale was rated by the clinician at every visit during the treatment phase (Week 1 through Week 10/early withdrawal) of the participant's total improvement or worsening compared with that individual's condition at the start of the study (the Randomization visit , Week 0) whether or not the change is judged to be due to drug treatment. The scores indicated the following: 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; 7= very much worse. The score ranged from 1-7, where 1 indicated very much improved and higher score indicated greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Data is reported for the percentage of participants who were much improved and very much improved. |
| Percentage of Participants Satisfied With Study Medication at Week 10 | Week 10 | Participants were asked complete the participant Satisfaction with Study Medication question at Week 10 (or early withdrawal). Satisfaction was measured using a single 7-point Likert scale from 1 to 7 where higher scores indicate greater satisfaction with study medication. A score of 1 represents very dissatisfied, whilst a score of 7 represents very satisfied. Participants were categorized as a responder if they are rated either as 6 Satisfied or 7 Very Satisfied. The proportion of responders as percentage of participants based on the participant satisfaction with study medication item was defined as: number of participants with a response of 6 or 7 at the visit divided by number of participants with a satisfaction with study medication assessment at that visit (the sum of responders and non-responders) multiplied by 100. |
| Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | Up to Week 10 | CSSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both behaviour and ideation. For SB scale, participants were scored as non-suicidal (00), preparatory acts or behavior communicating ideation (01), aborted attempt (02), interrupted attempt (03) or actual attempt (04) based on the most severe score (4 being the most severe). On SI scale, participants were scored as non-suicidal (00), wish to be dead (01), non-specific active suicidal thoughts (02), active suicidal ideation with associated thoughts of methods without intent (03), active suicidal ideation with some intent to act on suicidal thoughts without clear plan (04), active suicidal ideation with plan and intent (05), based on the most severe score (5 being the most severe). For both subscales, 0 indicated absence of symptom and higher score indicated greater severity of symptom. Only those scores for which at least one participant was reported are summarized. |
| Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 0 (Randomization) up to Week 8 | The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The total score ranged from 0-60, where 0 indicated no depression and 60 indicated severely depressed. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between MADRS total score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6 and 8) to Randomization. |
| Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 0 (Randomization) up to Week 10 | QIDS-CR16 is a 16-item rating scale of depressive symptoms rated by the clinician. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score was obtained by adding scores of items of sad mood, interest, energy/fatigue, sleep disturbance, decrease/increase in appetite or weight, concentration/decision making, suicidal ideation and psychomotor agitation/retardation, the highest score on any 1 of the 4 sleep items, highest score on any 1 appetite/weight item and highest score on either of the 2 psychomotor items. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between QIDS-CR16 total score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization. |
| Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Self-rated Version (QIDS-SR16) Total Score Over Week 10 | Week 0 (Randomization) up to Week 10 | QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by participant. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score was obtained by adding scores of the items of sad mood, interest, energy/fatigue, sleep disturbance, decrease/increase in appetite or weight, concentration/decision making, suicidal ideation and psychomotor agitation/retardation, the highest score on any 1 of the 4 sleep items, highest score on any 1 appetite/weight item and highest score on either of the 2 psychomotor items. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between QIDS-SR16 total score at the individual time points being analyzed (Week 1, 4 and 10) to Randomization. |
Countries
Bulgaria, Canada, Chile, Costa Rica, Croatia, France, Germany, India, Italy, Poland
Participant flow
Recruitment details
The study was conducted on male and female participants, aged 18 to 64, with major depressive episodes associated with major depressive disorder (MDD), from 19 December 2006 to 24 June 2008 at 35 centers in 10 countries of Canada (4), Bulgaria (2), Croatia (5), France (4), Germany (4), Italy (2), Poland (3), Chile (3), Costa Rica (3) and India (5).
Pre-assignment details
A total of 504 participants were randomized in ratio of 1:1:1 to receive placebo or GSK372475 (1.0 milligram per day \[mg/day\] to 1.5 mg/day) or paroxetine (20 mg/day to 30 mg/day) for 10 week double blind treatment phase.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received oral dose of matching placebo to capsule GSK372475/paroxetine for DL1 once daily in morning for 4 weeks of treatment period and DL2 once daily in morning for remaining 6 weeks. Dose escalation was based on investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (\>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization. | 156 |
| GSK372475 Participants received oral dose of GSK372475 1.0 mg/day capsule at dose level 1 (DL1) once daily in morning for 4 weeks of treatment period and 1.5 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (\>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed placebo capsules to maintain blind for Taper Phase of paroxetine, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization. | 171 |
| Paroxetine Participants received oral dose of paroxetine 20 mg/day capsule at DL1 once daily in morning for 4 weeks of treatment period and 30 mg/day capsule once daily in morning at DL2 for remaining 6 weeks. Dose escalation was based on the investigator's judgement of participant not experiencing any troublesome adverse signs or symptoms and not meeting response criteria (\>=50% reduction from randomization in MADRS total score). Treatment Phase of study was followed by a one week Taper Phase where participants were dosed at DL1, applicable for all participants who completed 10 week double-blind treatment phase on DL2 or who withdrew prematurely after having received at least 1 week of study medication on DL2. Lorazepam (or other specified comparable sedative) was permitted as a night-time sleep aid at the recommended dosage during first 2 weeks of study starting at randomization. | 166 |
| Total | 493 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 25 | 10 |
| Overall Study | Lack of Efficacy | 6 | 5 | 4 |
| Overall Study | Lost to Follow-up | 2 | 4 | 2 |
| Overall Study | Non-compliance | 7 | 5 | 4 |
| Overall Study | Other | 4 | 4 | 3 |
| Overall Study | Protocol Violation | 8 | 8 | 7 |
| Overall Study | Withdrawal by Subject | 15 | 21 | 14 |
Baseline characteristics
| Characteristic | Placebo | GSK372475 | Paroxetine | Total |
|---|---|---|---|---|
| Age, Continuous | 41.8 Years STANDARD_DEVIATION 10.89 | 42.4 Years STANDARD_DEVIATION 11.64 | 44.4 Years STANDARD_DEVIATION 10.9 | 42.9 Years STANDARD_DEVIATION 11.19 |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants | 11 Participants | 11 Participants | 30 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 14 Participants | 12 Participants | 39 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 128 Participants | 144 Participants | 137 Participants | 409 Participants |
| Sex: Female, Male Female | 117 Participants | 117 Participants | 111 Participants | 345 Participants |
| Sex: Female, Male Male | 39 Participants | 54 Participants | 55 Participants | 148 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 156 | 1 / 171 | 0 / 166 |
| other Total, other adverse events | 71 / 156 | 87 / 171 | 85 / 166 |
| serious Total, serious adverse events | 2 / 156 | 8 / 171 | 3 / 166 |
Outcome results
Primary
Change From Randomization at the End of the Treatment Phase (Week 10) in Bech Scale (6-item of 17-item Hamilton Depression Rating [HAMD-17] Scale) Score
The HAMD is a rating instrument for evaluating severity of symptoms of depression, was completed by the participant. The rating instrument used in this study was the 17-item version (HAM-D17). The Bech scale of the HAMD-17 is composed of 6 identified items out of the 17 items rated in HAMD-17 scale. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). The following symptoms were rated on a 5-point scale (0-4): depressed mood, feeling of guilt, work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). Total score ranged from 0 to 22, with 0 indicating absence of symptoms and a higher score indicating greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between Bech total score at the time point being analyzed (Week 10) to Randomization.
Time frame: Week 0 (Randomization) and Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Randomization at the End of the Treatment Phase (Week 10) in Bech Scale (6-item of 17-item Hamilton Depression Rating [HAMD-17] Scale) Score | -6.2 Score on scale | Standard Deviation 4.32 |
| GSK372475 | Change From Randomization at the End of the Treatment Phase (Week 10) in Bech Scale (6-item of 17-item Hamilton Depression Rating [HAMD-17] Scale) Score | -7.2 Score on scale | Standard Deviation 3.98 |
| Paroxetine | Change From Randomization at the End of the Treatment Phase (Week 10) in Bech Scale (6-item of 17-item Hamilton Depression Rating [HAMD-17] Scale) Score | -7.9 Score on scale | Standard Deviation 3.82 |
Comparison: Placebo versus GSK372475 in Bech score at Week 10.p-value: 0.25290% CI: [-1.28, 0.23]MMRM
Comparison: Placebo versus Paroxetine in MADRS total score at Week 10.p-value: 090% CI: [-2.49, -1.05]MMRM
Primary
Mean Change From Randomization at the End of the Treatment Phase in the MADRS Total Score
The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between MADRS total score at the time point being analyzed (Week 10) to Randomization.
Time frame: Week 0 (Randomization) and Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Randomization at the End of the Treatment Phase in the MADRS Total Score | -16.9 Score on scale | Standard Deviation 9.97 |
| GSK372475 | Mean Change From Randomization at the End of the Treatment Phase in the MADRS Total Score | -19.0 Score on scale | Standard Deviation 9.5 |
| Paroxetine | Mean Change From Randomization at the End of the Treatment Phase in the MADRS Total Score | -20.5 Score on scale | Standard Deviation 8.65 |
Comparison: Placebo versus GSK372475 in MADRS total score at Week 10.p-value: 0.48590% CI: [-2.6, 1.05]Mixed Model Repeated Measures (MMRM)
Comparison: Placebo versus Paroxetine in MADRS total score at Week 10.p-value: 090% CI: [-5.75, -2.22]MMRM
Primary
Mean Change From Randomization at the End of the Treatment Phase (Week 10) in Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Total Score
The IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. In order to calculate the total score of IDS-CR, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored. The total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS-CR total score at the time point being analyzed (Week 10) to Randomization.
Time frame: Week 0 (Randomization) and Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Total Score | -22.3 Score on scale | Standard Deviation 14.21 |
| GSK372475 | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Total Score | -25.1 Score on scale | Standard Deviation 13.3 |
| Paroxetine | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Total Score | -26.8 Score on scale | Standard Deviation 12.1 |
Comparison: Placebo versus GSK372475 in IDS-CR total score at Week 10.p-value: 0.27990% CI: [-4.19, 0.87]MMRM
Comparison: Placebo versus Paroxetine in IDS-CR total score at Week 10.p-value: 0.00190% CI: [-7.55, -2.68]MMRM
Secondary
Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score
HAMD-17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items of HAMD-17 are rated on a scale 3-point scale of 0-2 or a 5-point scale of 0-4 where 0 is absence of symptom and higher score indicate more severe symptom. Items rated on the 3-point scale include: insomnia early, middle, late; somatic symptoms gastrointestinal and general; genital symptoms; loss of weight; insight. Items rated on 5-point scale include: depressed mood; feelings of guilt; suicide; work and activities; retardation; agitation; anxiety psychic and somatic; hypochondriasis. Total score ranges from 0 to 52, where 0 indicates absence of symptom and higher scores indicates more severe symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between HAMD-17 total score at the time point being analyzed (Week 10) to Randomization.
Time frame: Week 0 (Randomization) and Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 1 | -1.9 Score on scale | Standard Deviation 4.11 |
| Placebo | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 2 | -4.3 Score on scale | Standard Deviation 4.87 |
| Placebo | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 3 | -6.6 Score on scale | Standard Deviation 5.66 |
| Placebo | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 5 | -8.5 Score on scale | Standard Deviation 6.36 |
| Placebo | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 6 | -9.9 Score on scale | Standard Deviation 7.08 |
| Placebo | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 8 | -10.4 Score on scale | Standard Deviation 7.88 |
| Placebo | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 10 | -11.5 Score on scale | Standard Deviation 7.73 |
| Placebo | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 4 | -7.7 Score on scale | Standard Deviation 6.51 |
| GSK372475 | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 8 | -11.5 Score on scale | Standard Deviation 7.78 |
| GSK372475 | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 1 | -1.9 Score on scale | Standard Deviation 4.16 |
| GSK372475 | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 5 | -7.8 Score on scale | Standard Deviation 7.68 |
| GSK372475 | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 4 | -6.3 Score on scale | Standard Deviation 6.3 |
| GSK372475 | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 2 | -4.2 Score on scale | Standard Deviation 5.82 |
| GSK372475 | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 10 | -12.9 Score on scale | Standard Deviation 7.46 |
| GSK372475 | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 6 | -9.5 Score on scale | Standard Deviation 8.38 |
| GSK372475 | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 3 | -4.9 Score on scale | Standard Deviation 6.73 |
| Paroxetine | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 3 | -6.9 Score on scale | Standard Deviation 6.39 |
| Paroxetine | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 4 | -7.9 Score on scale | Standard Deviation 6.43 |
| Paroxetine | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 5 | -9.9 Score on scale | Standard Deviation 6.34 |
| Paroxetine | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 6 | -11.6 Score on scale | Standard Deviation 6.62 |
| Paroxetine | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 1 | -2.3 Score on scale | Standard Deviation 4.36 |
| Paroxetine | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 10 | -13.9 Score on scale | Standard Deviation 6.89 |
| Paroxetine | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 2 | -4.8 Score on scale | Standard Deviation 5.99 |
| Paroxetine | Mean Change From Randomization at the End of the Treatment Phase (Week 10) in the HAMD-17 Total Score | Week 8 | -12.7 Score on scale | Standard Deviation 7.02 |
Comparison: Placebo versus GSK372475 in HAMD-17 total score at Week 10.p-value: 0.57690% CI: [-1.84, 0.91]MMRM
Comparison: Placebo versus Paroxetine in HAMD-17 total score at Week 10.p-value: 090% CI: [-4.28, -1.64]MMRM
Secondary
Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10
The IDS-CR and IDS-SR is a standardized 30-item scale rated by the clinician and the participant respectively to assess the severity of a participant's depressive symptoms. The 5 items of the IDS subscale include: item 19 (general interest/involvement), item 20 (energy/fatigability), item 21 (pleasure/enjoyment), item 22 (sexual interest), item 30 (Leaden paralysis/physical energy) which assessed participant's pleasure, interest and energy. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score ranges from 0 to 15, where 0 indicates absence of symptom and higher scores indicates more severe symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS 5 Item subscale total score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.
Time frame: Week 0 (Randomization) up to Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 6 | -4.4 Score on scale | Standard Deviation 3.76 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 5 | -0.7 Score on scale | Standard Deviation 1.5 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 8 | -2.5 Score on scale | Standard Deviation 2.12 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 8 | -4.8 Score on scale | Standard Deviation 3.85 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 4 | -3.5 Score on scale | Standard Deviation 3.96 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 3 | -2.6 Score on scale | Standard Deviation 3.05 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 10 | -5.3 Score on scale | Standard Deviation 3.73 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 5 | -3.8 Score on scale | Standard Deviation 3.24 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 10 | -6.2 Score on scale | Standard Deviation 4.53 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 1 | -1.3 Score on scale | Standard Deviation 2.48 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 1 | -0.8 Score on scale | Standard Deviation 2.08 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 2 | -3.0 Score on scale | Standard Deviation 4.55 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 6 | -2.8 Score on scale | Standard Deviation 3.76 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 4 | -3.1 Score on scale | Standard Deviation 3.41 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 3 | 0.0 Score on scale | Standard Deviation 0 |
| Placebo | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 2 | -1.6 Score on scale | Standard Deviation 2.49 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 3 | -3.4 Score on scale | Standard Deviation 5.91 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 4 | -4.7 Score on scale | Standard Deviation 4.12 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 5 | -5.9 Score on scale | Standard Deviation 3.81 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 6 | -1.0 Score on scale | Standard Deviation 5.37 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 5 | -4.3 Score on scale | Standard Deviation 3.6 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 8 | -7.0 Score on scale | Standard Deviation 3.61 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 2 | -2.5 Score on scale | Standard Deviation 2.85 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 10 | -7.6 Score on scale | Standard Deviation 4.21 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 1 | -2.5 Score on scale | Standard Deviation 3.1 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 6 | -4.8 Score on scale | Standard Deviation 3.81 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 1 | -1.2 Score on scale | Standard Deviation 2.32 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 8 | -5.6 Score on scale | Standard Deviation 3.56 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 10 | -6.2 Score on scale | Standard Deviation 3.42 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 3 | -2.9 Score on scale | Standard Deviation 3.13 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 2 | -2.1 Score on scale | Standard Deviation 2.97 |
| GSK372475 | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 4 | -3.5 Score on scale | Standard Deviation 3.13 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 10 | -7.9 Score on scale | Standard Deviation 4.26 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 1 | -0.8 Score on scale | Standard Deviation 2.21 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 2 | -2.0 Score on scale | Standard Deviation 2.85 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 3 | -2.9 Score on scale | Standard Deviation 3.12 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 4 | -3.4 Score on scale | Standard Deviation 3.06 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 5 | -4.4 Score on scale | Standard Deviation 3.41 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 6 | -5.2 Score on scale | Standard Deviation 3.59 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 8 | -5.9 Score on scale | Standard Deviation 3.41 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-CR 5 Item subscale, Week 10 | -6.3 Score on scale | Standard Deviation 3.21 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 1 | -2.2 Score on scale | Standard Deviation 3.09 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 2 | -3.3 Score on scale | Standard Deviation 4.16 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 3 | -3.7 Score on scale | Standard Deviation 5.99 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 4 | -4.9 Score on scale | Standard Deviation 3.85 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 5 | -5.0 Score on scale | Standard Deviation 6.52 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 6 | -3.3 Score on scale | Standard Deviation 2.52 |
| Paroxetine | Mean Change From Randomization in IDS-CR and IDS-SR 5 Item Subscale Over Week 10 | IDS-SR 5 Item subscale, Week 8 | -6.3 Score on scale | Standard Deviation 4.04 |
Comparison: Placebo versus GSK372475 in IDS-CR 5 Item subscale total score at Week 10.p-value: 0.17590% CI: [-1.23, 0.12]MMRM
Comparison: Placebo versus Paroxetine in IDS-CR 5 Item subscale total score at Week 10.p-value: 0.00390% CI: [-1.79, -0.5]MMRM
Comparison: Placebo versus GSK372475 in IDS-SR 5 Item subscale total score at Week 10.p-value: 0.08290% CI: [-1.92, -0.05]MMRM
Comparison: Placebo versus Paroxetine in IDS-SR 5 Item subscale total score at Week 10.p-value: 0.00190% CI: [-2.64, -0.9]MMRM
Secondary
Mean Change From Randomization in IDS-CR Total Score Over Week 8
The IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. In order to calculate the total score of IDS-CR, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored. The total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS-CR total score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6 and 8) to Randomization.
Time frame: Week 0 (Randomization) up to Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 6 | -19.5 Score on scale | Standard Deviation 13.11 |
| Placebo | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 1 | -4.4 Score on scale | Standard Deviation 7.16 |
| Placebo | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 2 | -8.8 Score on scale | Standard Deviation 9.03 |
| Placebo | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 3 | -12.7 Score on scale | Standard Deviation 11.07 |
| Placebo | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 4 | -15.0 Score on scale | Standard Deviation 12.42 |
| Placebo | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 5 | -16.9 Score on scale | Standard Deviation 11.51 |
| Placebo | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 8 | -20.3 Score on scale | Standard Deviation 14.81 |
| GSK372475 | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 5 | -16.9 Score on scale | Standard Deviation 13.07 |
| GSK372475 | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 4 | -13.2 Score on scale | Standard Deviation 10.97 |
| GSK372475 | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 1 | -4.9 Score on scale | Standard Deviation 7.54 |
| GSK372475 | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 3 | -11.2 Score on scale | Standard Deviation 11.36 |
| GSK372475 | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 6 | -19.3 Score on scale | Standard Deviation 14.4 |
| GSK372475 | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 2 | -9.7 Score on scale | Standard Deviation 10.37 |
| GSK372475 | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 8 | -22.8 Score on scale | Standard Deviation 14.09 |
| Paroxetine | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 2 | -9.8 Score on scale | Standard Deviation 11.55 |
| Paroxetine | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 3 | -14.3 Score on scale | Standard Deviation 11.9 |
| Paroxetine | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 8 | -25.2 Score on scale | Standard Deviation 12.77 |
| Paroxetine | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 4 | -16.2 Score on scale | Standard Deviation 11.8 |
| Paroxetine | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 5 | -20.1 Score on scale | Standard Deviation 12.05 |
| Paroxetine | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 1 | -5.1 Score on scale | Standard Deviation 8.56 |
| Paroxetine | Mean Change From Randomization in IDS-CR Total Score Over Week 8 | Week 6 | -23.4 Score on scale | Standard Deviation 12.6 |
Secondary
Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10
The IDS-SR is a standardized 30-item, participant rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. In order to calculate the total score of IDS-SR, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored. The total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between IDS-SR total score at the individual time points being analyzed (Week, 1, 4 and 10) to Randomization.
Time frame: Week 0 (Randomization) up to Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10 | Week 4 | -16.8 Score on scale | Standard Deviation 12.12 |
| Placebo | Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10 | Week 1 | -7.6 Score on scale | Standard Deviation 9.05 |
| Placebo | Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10 | Week 10 | -25.6 Score on scale | Standard Deviation 16.27 |
| GSK372475 | Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10 | Week 4 | -15.5 Score on scale | Standard Deviation 13 |
| GSK372475 | Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10 | Week 1 | -7.6 Score on scale | Standard Deviation 9.15 |
| GSK372475 | Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10 | Week 10 | -26.9 Score on scale | Standard Deviation 14.73 |
| Paroxetine | Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10 | Week 1 | -8.6 Score on scale | Standard Deviation 9.96 |
| Paroxetine | Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10 | Week 10 | -30.5 Score on scale | Standard Deviation 13.66 |
| Paroxetine | Mean Change From Randomization in IDS- Self-Rated Version (SR) Total Score Over Week 10 | Week 4 | -19.1 Score on scale | Standard Deviation 12.55 |
Comparison: Placebo versus GSK372475 in IDS-SR total score at Week 10.p-value: 0.28790% CI: [-5.23, 1.12]MMRM
Comparison: Placebo versus Paroxetine in IDS-SR total score at Week 10.p-value: 0.00190% CI: [-9.21, -3.25]MMRM
Secondary
Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10
QIDS-CR16 is a 16-item rating scale of depressive symptoms rated by the clinician. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score was obtained by adding scores of items of sad mood, interest, energy/fatigue, sleep disturbance, decrease/increase in appetite or weight, concentration/decision making, suicidal ideation and psychomotor agitation/retardation, the highest score on any 1 of the 4 sleep items, highest score on any 1 appetite/weight item and highest score on either of the 2 psychomotor items. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between QIDS-CR16 total score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.
Time frame: Week 0 (Randomization) up to Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 1 | -1.5 Score on scale | Standard Deviation 2.78 |
| Placebo | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 2 | -3.3 Score on scale | Standard Deviation 3.67 |
| Placebo | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 3 | -5.0 Score on scale | Standard Deviation 4.27 |
| Placebo | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 4 | -5.9 Score on scale | Standard Deviation 4.75 |
| Placebo | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 5 | -6.5 Score on scale | Standard Deviation 4.64 |
| Placebo | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 6 | -7.3 Score on scale | Standard Deviation 4.88 |
| Placebo | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 8 | -7.8 Score on scale | Standard Deviation 5.58 |
| Placebo | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 10 | -8.5 Score on scale | Standard Deviation 5.31 |
| GSK372475 | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 3 | -4.3 Score on scale | Standard Deviation 4.24 |
| GSK372475 | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 8 | -8.8 Score on scale | Standard Deviation 5.07 |
| GSK372475 | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 4 | -5.0 Score on scale | Standard Deviation 4.2 |
| GSK372475 | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 5 | -6.6 Score on scale | Standard Deviation 5.09 |
| GSK372475 | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 6 | -7.3 Score on scale | Standard Deviation 5.55 |
| GSK372475 | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 1 | -1.8 Score on scale | Standard Deviation 2.76 |
| GSK372475 | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 2 | -3.6 Score on scale | Standard Deviation 4.01 |
| GSK372475 | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 10 | -9.6 Score on scale | Standard Deviation 4.95 |
| Paroxetine | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 3 | -5.3 Score on scale | Standard Deviation 4.64 |
| Paroxetine | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 2 | -3.4 Score on scale | Standard Deviation 4.7 |
| Paroxetine | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 1 | -1.8 Score on scale | Standard Deviation 3.65 |
| Paroxetine | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 4 | -5.9 Score on scale | Standard Deviation 4.61 |
| Paroxetine | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 8 | -9.4 Score on scale | Standard Deviation 5.03 |
| Paroxetine | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 6 | -8.6 Score on scale | Standard Deviation 4.92 |
| Paroxetine | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 5 | -7.4 Score on scale | Standard Deviation 4.82 |
| Paroxetine | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Clinician-rated Version (QIDS-CR16) Total Score Over Week 10 | Week 10 | -10.0 Score on scale | Standard Deviation 4.85 |
Comparison: Placebo versus GSK372475 in QIDS-CR16 total score at Week 10.p-value: 0.35290% CI: [-1.47, 0.41]MMRM
Comparison: Placebo versus Paroxetine in QIDS-CR16 total score at Week 10.p-value: 0.00290% CI: [-2.62, -0.81]MMRM
Secondary
Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Self-rated Version (QIDS-SR16) Total Score Over Week 10
QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by participant. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score was obtained by adding scores of the items of sad mood, interest, energy/fatigue, sleep disturbance, decrease/increase in appetite or weight, concentration/decision making, suicidal ideation and psychomotor agitation/retardation, the highest score on any 1 of the 4 sleep items, highest score on any 1 appetite/weight item and highest score on either of the 2 psychomotor items. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating most severe depression. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between QIDS-SR16 total score at the individual time points being analyzed (Week 1, 4 and 10) to Randomization.
Time frame: Week 0 (Randomization) up to Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Self-rated Version (QIDS-SR16) Total Score Over Week 10 | Week 4 | -6.4 Score on scale | Standard Deviation 5.23 |
| Placebo | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Self-rated Version (QIDS-SR16) Total Score Over Week 10 | Week 1 | -2.7 Score on scale | Standard Deviation 3.82 |
| Placebo | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Self-rated Version (QIDS-SR16) Total Score Over Week 10 | Week 10 | -10.0 Score on scale | Standard Deviation 6.73 |
| GSK372475 | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Self-rated Version (QIDS-SR16) Total Score Over Week 10 | Week 4 | -5.7 Score on scale | Standard Deviation 5.31 |
| GSK372475 | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Self-rated Version (QIDS-SR16) Total Score Over Week 10 | Week 1 | -3.1 Score on scale | Standard Deviation 4 |
| GSK372475 | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Self-rated Version (QIDS-SR16) Total Score Over Week 10 | Week 10 | -10.6 Score on scale | Standard Deviation 5.64 |
| Paroxetine | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Self-rated Version (QIDS-SR16) Total Score Over Week 10 | Week 1 | -2.9 Score on scale | Standard Deviation 4.16 |
| Paroxetine | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Self-rated Version (QIDS-SR16) Total Score Over Week 10 | Week 10 | -11.6 Score on scale | Standard Deviation 5.39 |
| Paroxetine | Mean Change From Randomization in the 16-item Quick Inventory of Depressive Symptomatology-Self-rated Version (QIDS-SR16) Total Score Over Week 10 | Week 4 | -6.9 Score on scale | Standard Deviation 5.1 |
Comparison: Placebo versus GSK372475 in QIDS-SR16 total score at Week 10.p-value: 0.16890% CI: [-2.27, 0.2]MMRM
Comparison: Placebo versus Paroxetine in QIDS-SR16 total score at Week 10.p-value: 0.00290% CI: [-3.27, -0.97]MMRM
Secondary
Mean Change From Randomization in the Changes in Sexual Functioning Questionnaire 14-item Short Form (CSFQ-14SF) Over Week 10
The CSFQ-14SF is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning. It is consisting of 14 items that measure sexual activity and sexual functioning. It measures five dimensions of sexual behavior: pleasure (1 item); desire/frequency (items 2 and 3); desire/interest (items 4, 5 and 6); arousal (items 7, 8 and 9); and orgasm (items 11, 12 and 13). Items 10 and 14 are included in the total score but not in any dimension score. Items were rated on an 5 point scale from 1 to 5. Total score ranged from 14 to 70, where higher scores indicate higher sexual functioning and lower score indicate lower sexual functioning. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in the total score was the difference between CSFQ-14SF score at the individual time points being analyzed (Week 4 and 10) to Randomization.
Time frame: Week 0 (Randomization) up to Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Randomization in the Changes in Sexual Functioning Questionnaire 14-item Short Form (CSFQ-14SF) Over Week 10 | Week 4 | 2.4 Score on scale | Standard Deviation 5.44 |
| Placebo | Mean Change From Randomization in the Changes in Sexual Functioning Questionnaire 14-item Short Form (CSFQ-14SF) Over Week 10 | Week 10 | 4.6 Score on scale | Standard Deviation 8.17 |
| GSK372475 | Mean Change From Randomization in the Changes in Sexual Functioning Questionnaire 14-item Short Form (CSFQ-14SF) Over Week 10 | Week 4 | 3.1 Score on scale | Standard Deviation 7.63 |
| GSK372475 | Mean Change From Randomization in the Changes in Sexual Functioning Questionnaire 14-item Short Form (CSFQ-14SF) Over Week 10 | Week 10 | 6.1 Score on scale | Standard Deviation 8.95 |
| Paroxetine | Mean Change From Randomization in the Changes in Sexual Functioning Questionnaire 14-item Short Form (CSFQ-14SF) Over Week 10 | Week 4 | 1.3 Score on scale | Standard Deviation 8.08 |
| Paroxetine | Mean Change From Randomization in the Changes in Sexual Functioning Questionnaire 14-item Short Form (CSFQ-14SF) Over Week 10 | Week 10 | 4.4 Score on scale | Standard Deviation 9.3 |
Comparison: Placebo versus GSK372475 in CSFQ-14SF total score at Week 10.p-value: 0.12690% CI: [-0.13, 3.57]MMRM
Comparison: Placebo versus Paroxetine in CSFQ-14SF total score at Week 10.p-value: 0.95790% CI: [-1.69, 1.81]MMRM
Secondary
Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10
The CGI-S scale measures the severity of psychiatric symptoms on a 7-point scale from 1-7. The scores indicated the following: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. The score ranged from 1-7, where 1 indicated absence of symptoms and higher score indicated greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in the score was the difference between CGI-S score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.
Time frame: Week 0 (Randomization) up to Week 10
Population: ITT Population with OC analysis. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 1 | -0.2 Score on scale | Standard Deviation 0.54 |
| Placebo | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 2 | -0.5 Score on scale | Standard Deviation 0.7 |
| Placebo | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 3 | -0.8 Score on scale | Standard Deviation 0.91 |
| Placebo | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 4 | -1.1 Score on scale | Standard Deviation 1.11 |
| Placebo | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 5 | -1.2 Score on scale | Standard Deviation 1.23 |
| Placebo | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 6 | -1.5 Score on scale | Standard Deviation 1.3 |
| Placebo | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 8 | -1.7 Score on scale | Standard Deviation 1.4 |
| Placebo | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 10 | -1.9 Score on scale | Standard Deviation 1.41 |
| GSK372475 | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 3 | -0.7 Score on scale | Standard Deviation 1.09 |
| GSK372475 | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 8 | -1.9 Score on scale | Standard Deviation 1.51 |
| GSK372475 | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 4 | -1.0 Score on scale | Standard Deviation 1.2 |
| GSK372475 | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 5 | -1.4 Score on scale | Standard Deviation 1.41 |
| GSK372475 | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 6 | -1.6 Score on scale | Standard Deviation 1.54 |
| GSK372475 | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 1 | -0.3 Score on scale | Standard Deviation 0.55 |
| GSK372475 | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 2 | -0.5 Score on scale | Standard Deviation 0.93 |
| GSK372475 | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 10 | -2.2 Score on scale | Standard Deviation 1.54 |
| Paroxetine | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 3 | -1.1 Score on scale | Standard Deviation 1.19 |
| Paroxetine | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 2 | -0.6 Score on scale | Standard Deviation 0.88 |
| Paroxetine | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 1 | -0.2 Score on scale | Standard Deviation 0.56 |
| Paroxetine | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 4 | -1.3 Score on scale | Standard Deviation 1.28 |
| Paroxetine | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 8 | -2.2 Score on scale | Standard Deviation 1.31 |
| Paroxetine | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 6 | -2.0 Score on scale | Standard Deviation 1.36 |
| Paroxetine | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 5 | -1.6 Score on scale | Standard Deviation 1.28 |
| Paroxetine | Mean Change From Randomization in the Clinical Global Impression-Severity of Illness (CGI-S) Scale Over Week 10 | Week 10 | -2.5 Score on scale | Standard Deviation 1.27 |
Comparison: Placebo versus GSK372475 in CGI-S score at Week 10.p-value: 0.20890% CI: [-0.45, 0.06]MMRM
Comparison: Placebo versus Paroxetine in CGI-S score at Week 10.p-value: 090% CI: [-0.76, -0.28]MMRM
Secondary
Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10
HAMD-17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAMD-17 are rated on a 3-point scale of 0-2 or a 5-point scale of 0-4. The item 1 (Depressed Mood) of HAMD-17 was rated the 5-point scale of 0-4, where 0 indicates absence of symptom and higher score indicates more severe symptom. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in the score was the difference between HAMD-17 Item 1 score at the individual time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.
Time frame: Week 0 (Randomization) up to Week 10
Population: ITT Population with OC analysis. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 10 | -1.7 Score on scale | Standard Deviation 1.24 |
| Placebo | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 1 | -0.3 Score on scale | Standard Deviation 0.69 |
| Placebo | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 4 | -1.0 Score on scale | Standard Deviation 1.1 |
| Placebo | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 3 | -1.0 Score on scale | Standard Deviation 1.06 |
| Placebo | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 2 | -0.6 Score on scale | Standard Deviation 0.84 |
| Placebo | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 5 | -1.2 Score on scale | Standard Deviation 1.11 |
| Placebo | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 8 | -1.4 Score on scale | Standard Deviation 1.18 |
| Placebo | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 6 | -1.3 Score on scale | Standard Deviation 1.16 |
| GSK372475 | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 2 | -0.7 Score on scale | Standard Deviation 1.03 |
| GSK372475 | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 6 | -1.5 Score on scale | Standard Deviation 1.31 |
| GSK372475 | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 1 | -0.4 Score on scale | Standard Deviation 0.83 |
| GSK372475 | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 8 | -1.8 Score on scale | Standard Deviation 1.13 |
| GSK372475 | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 10 | -2.0 Score on scale | Standard Deviation 1.18 |
| GSK372475 | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 3 | -0.9 Score on scale | Standard Deviation 1.12 |
| GSK372475 | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 4 | -1.0 Score on scale | Standard Deviation 1.1 |
| GSK372475 | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 5 | -1.2 Score on scale | Standard Deviation 1.21 |
| Paroxetine | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 10 | -2.0 Score on scale | Standard Deviation 1.06 |
| Paroxetine | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 1 | -0.3 Score on scale | Standard Deviation 0.79 |
| Paroxetine | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 2 | -0.7 Score on scale | Standard Deviation 0.97 |
| Paroxetine | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 3 | -1.0 Score on scale | Standard Deviation 1.01 |
| Paroxetine | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 4 | -1.2 Score on scale | Standard Deviation 1.04 |
| Paroxetine | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 5 | -1.5 Score on scale | Standard Deviation 1.06 |
| Paroxetine | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 6 | -1.7 Score on scale | Standard Deviation 1.03 |
| Paroxetine | Mean Change From Randomization in the HAMD-17 Scale Item 1 (Depressed Mood) Over Week 10 | Week 8 | -1.8 Score on scale | Standard Deviation 1.06 |
Comparison: Placebo versus GSK372475 in HAMD-17 Item 1 score at Week 10.p-value: 0.20990% CI: [-0.38, 0.05]MMRM
Comparison: Placebo versus Paroxetine in HAMD-17 Item 1 score at Week 10.p-value: 0.00290% CI: [-0.6, -0.19]MMRM
Secondary
Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10
The IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The item 5 (Feeling Sad) of IDS-CR was rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in score was the difference between IDS-CR Item 5 score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.
Time frame: Week 0 (Randomization) up to Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 6 | -1.1 Score on scale | Standard Deviation 0.9 |
| Placebo | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 4 | -0.9 Score on scale | Standard Deviation 0.84 |
| Placebo | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 10 | -1.3 Score on scale | Standard Deviation 0.95 |
| Placebo | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 5 | -1.0 Score on scale | Standard Deviation 0.84 |
| Placebo | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 2 | -0.5 Score on scale | Standard Deviation 0.72 |
| Placebo | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 1 | -0.2 Score on scale | Standard Deviation 0.61 |
| Placebo | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 8 | -1.2 Score on scale | Standard Deviation 0.92 |
| Placebo | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 3 | -0.8 Score on scale | Standard Deviation 0.74 |
| GSK372475 | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 3 | -0.8 Score on scale | Standard Deviation 0.91 |
| GSK372475 | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 1 | -0.3 Score on scale | Standard Deviation 0.7 |
| GSK372475 | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 2 | -0.5 Score on scale | Standard Deviation 0.85 |
| GSK372475 | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 4 | -0.8 Score on scale | Standard Deviation 0.93 |
| GSK372475 | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 5 | -1.0 Score on scale | Standard Deviation 1.06 |
| GSK372475 | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 6 | -1.2 Score on scale | Standard Deviation 1.12 |
| GSK372475 | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 8 | -1.4 Score on scale | Standard Deviation 0.98 |
| GSK372475 | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 10 | -1.5 Score on scale | Standard Deviation 0.99 |
| Paroxetine | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 1 | -0.3 Score on scale | Standard Deviation 0.75 |
| Paroxetine | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 6 | -1.5 Score on scale | Standard Deviation 0.87 |
| Paroxetine | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 2 | -0.6 Score on scale | Standard Deviation 0.87 |
| Paroxetine | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 10 | -1.7 Score on scale | Standard Deviation 0.88 |
| Paroxetine | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 4 | -1.0 Score on scale | Standard Deviation 0.83 |
| Paroxetine | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 8 | -1.6 Score on scale | Standard Deviation 0.9 |
| Paroxetine | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 5 | -1.3 Score on scale | Standard Deviation 0.86 |
| Paroxetine | Mean Change From Randomization in the IDS-CR Scale Item 5 (Feeling Sad) Over Week 10 | Week 3 | -0.9 Score on scale | Standard Deviation 0.82 |
Comparison: Placebo versus GSK372475 in IDS-CR Item 5 score at Week 10.p-value: 0.09690% CI: [-0.33, 0]MMRM
Comparison: Placebo versus Paroxetine in IDS-CR Item 5 at Week 10.p-value: 090% CI: [-0.53, -0.22]MMRM
Secondary
Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8
The HAMD is a rating instrument for evaluating severity of symptoms of depression, was completed by the participant. Rating instrument used in this study was the 17-item version (HAM-D17). The Bech scale of the HAMD-17 is composed of 6 identified items out of the 17 items rated in HAMD-17 scale. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). The following symptoms were rated on a 5-point scale (0-4): depressed mood, feeling of guilt, work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). Total score ranged from 0 to 22, with 0 indicating absence of symptoms and a higher score indicating greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between Bech total score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6 and 8) to randomization.
Time frame: Week 0 (Randomization) up to Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 2 | -2.0 Score on scale | Standard Deviation 2.58 |
| Placebo | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 5 | -4.4 Score on scale | Standard Deviation 3.42 |
| Placebo | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 4 | -3.9 Score on scale | Standard Deviation 3.62 |
| Placebo | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 1 | -0.8 Score on scale | Standard Deviation 2.06 |
| Placebo | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 8 | -5.3 Score on scale | Standard Deviation 4.19 |
| Placebo | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 6 | -5.1 Score on scale | Standard Deviation 4.03 |
| Placebo | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 3 | -3.3 Score on scale | Standard Deviation 3.1 |
| GSK372475 | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 4 | -3.5 Score on scale | Standard Deviation 3.6 |
| GSK372475 | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 1 | -1.0 Score on scale | Standard Deviation 2.55 |
| GSK372475 | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 2 | -2.2 Score on scale | Standard Deviation 3.25 |
| GSK372475 | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 3 | -2.8 Score on scale | Standard Deviation 3.82 |
| GSK372475 | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 5 | -4.4 Score on scale | Standard Deviation 4.26 |
| GSK372475 | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 6 | -5.4 Score on scale | Standard Deviation 4.44 |
| GSK372475 | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 8 | -6.3 Score on scale | Standard Deviation 4.1 |
| Paroxetine | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 5 | -5.6 Score on scale | Standard Deviation 3.61 |
| Paroxetine | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 2 | -2.6 Score on scale | Standard Deviation 3.28 |
| Paroxetine | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 8 | -7.2 Score on scale | Standard Deviation 3.92 |
| Paroxetine | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 6 | -6.5 Score on scale | Standard Deviation 3.78 |
| Paroxetine | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 4 | -4.3 Score on scale | Standard Deviation 3.63 |
| Paroxetine | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 3 | -3.8 Score on scale | Standard Deviation 3.56 |
| Paroxetine | Mean Change From Randomization in the in Bech Scale (6-item of HAMD-17 Scale) Score Over Week 8 | Week 1 | -1.2 Score on scale | Standard Deviation 2.52 |
Secondary
Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10
The MADRS scale measures the depression level of a participant. The items of the scale include: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. The item 2 (Reported Sadness) of MADRS was scored using a scale 7-point scale of 0-6, where 0 indicates absence of symptom and higher score indicates increased severity of symptom. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between MADRS Item 2 score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6, 8 and 10) to Randomization.
Time frame: Week 0 (Randomization) up to Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 10 | -2.4 Score on scale | Standard Deviation 1.52 |
| Placebo | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 6 | -1.9 Score on scale | Standard Deviation 1.56 |
| Placebo | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 1 | -0.4 Score on scale | Standard Deviation 0.84 |
| Placebo | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 5 | -1.6 Score on scale | Standard Deviation 1.43 |
| Placebo | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 8 | -2.0 Score on scale | Standard Deviation 1.43 |
| Placebo | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 2 | -0.8 Score on scale | Standard Deviation 1 |
| Placebo | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 4 | -1.5 Score on scale | Standard Deviation 1.42 |
| Placebo | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 3 | -1.3 Score on scale | Standard Deviation 1.26 |
| GSK372475 | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 8 | -2.4 Score on scale | Standard Deviation 1.33 |
| GSK372475 | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 3 | -1.2 Score on scale | Standard Deviation 1.28 |
| GSK372475 | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 6 | -2.0 Score on scale | Standard Deviation 1.53 |
| GSK372475 | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 4 | -1.4 Score on scale | Standard Deviation 1.23 |
| GSK372475 | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 5 | -1.7 Score on scale | Standard Deviation 1.42 |
| GSK372475 | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 10 | -2.7 Score on scale | Standard Deviation 1.36 |
| GSK372475 | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 1 | -0.5 Score on scale | Standard Deviation 0.95 |
| GSK372475 | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 2 | -0.9 Score on scale | Standard Deviation 1.15 |
| Paroxetine | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 1 | -0.4 Score on scale | Standard Deviation 0.97 |
| Paroxetine | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 6 | -2.4 Score on scale | Standard Deviation 1.29 |
| Paroxetine | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 8 | -2.6 Score on scale | Standard Deviation 1.34 |
| Paroxetine | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 10 | -2.9 Score on scale | Standard Deviation 1.28 |
| Paroxetine | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 5 | -2.1 Score on scale | Standard Deviation 1.28 |
| Paroxetine | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 2 | -0.9 Score on scale | Standard Deviation 1.27 |
| Paroxetine | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 3 | -1.5 Score on scale | Standard Deviation 1.28 |
| Paroxetine | Mean Change From Randomization in the MADRS Item 2 Score (Reported Sadness) Over Week 10 | Week 4 | -1.6 Score on scale | Standard Deviation 1.34 |
Comparison: Placebo versus GSK372475 in MADRS Item 2 score at Week 10.p-value: 0.25790% CI: [-0.46, 0.09]MMRM
Comparison: Placebo versus Paroxetine in MADRS Item 2 score at Week 10.p-value: 0.00190% CI: [-0.77, -0.25]MMRM
Secondary
Mean Change From Randomization in the MADRS Total Score Over Week 8
The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The total score ranged from 0-60, where 0 indicated no depression and 60 indicated severely depressed. Randomization value was defined as the assessment value done on Week 0. Change from Randomization in total score was the difference between MADRS total score at the time points being analyzed (Week 1, 2, 3, 4, 5, 6 and 8) to Randomization.
Time frame: Week 0 (Randomization) up to Week 8
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 5 | -12.0 Score on scale | Standard Deviation 9.24 |
| Placebo | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 2 | -6.3 Score on scale | Standard Deviation 6.78 |
| Placebo | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 6 | -14.3 Score on scale | Standard Deviation 9.98 |
| Placebo | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 8 | -15.1 Score on scale | Standard Deviation 10.09 |
| Placebo | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 4 | -11.0 Score on scale | Standard Deviation 9.23 |
| Placebo | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 1 | -2.9 Score on scale | Standard Deviation 5.4 |
| Placebo | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 3 | -9.7 Score on scale | Standard Deviation 8.45 |
| GSK372475 | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 6 | -14.5 Score on scale | Standard Deviation 10.59 |
| GSK372475 | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 5 | -11.9 Score on scale | Standard Deviation 9.69 |
| GSK372475 | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 3 | -7.3 Score on scale | Standard Deviation 8.56 |
| GSK372475 | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 2 | -5.7 Score on scale | Standard Deviation 7.62 |
| GSK372475 | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 1 | -2.8 Score on scale | Standard Deviation 5.61 |
| GSK372475 | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 8 | -17.3 Score on scale | Standard Deviation 9.65 |
| GSK372475 | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 4 | -9.5 Score on scale | Standard Deviation 8.08 |
| Paroxetine | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 8 | -19.1 Score on scale | Standard Deviation 9.14 |
| Paroxetine | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 1 | -2.8 Score on scale | Standard Deviation 5.98 |
| Paroxetine | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 2 | -6.6 Score on scale | Standard Deviation 8.5 |
| Paroxetine | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 3 | -10.1 Score on scale | Standard Deviation 8.59 |
| Paroxetine | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 4 | -11.4 Score on scale | Standard Deviation 8.67 |
| Paroxetine | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 5 | -14.9 Score on scale | Standard Deviation 8.91 |
| Paroxetine | Mean Change From Randomization in the MADRS Total Score Over Week 8 | Week 6 | -17.3 Score on scale | Standard Deviation 8.75 |
Secondary
Mean Change From Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) Total Score Over Week 10
MEI 18 item-SF questionnaire was used to measure reductions in mental energy, physical energy, and social motivation. All items use either a 7-level (0-6) or 5-level (0-4) response scale; for questions 1, 2, and 13-18, response '0' indicates lower motivation, energy and interest and responses with higher scores indicate increased motivation, energy and interest. For questions 3-12, response '0' indicates higher motivation, energy and interest and responses with higher scores indicate lower motivation, energy and interest. Items with a 5-level response scale were rescaled to 7-levels, and items were reverse-scored. Total score ranges from 0-108, where 0 indicates lower motivation, energy and interest and higher score indicates higher motivation, energy and interest. Randomization value was defined as assessment value done on Week 0. Change from Randomization in total score was difference between MEI score at individual time points being analyzed (Week 1, 4 and 10) to Randomization.
Time frame: Week 0 (Randomization) up to Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) Total Score Over Week 10 | Week 4 | 16.1 Score on scale | Standard Deviation 16.18 |
| Placebo | Mean Change From Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) Total Score Over Week 10 | Week 1 | 3.8 Score on scale | Standard Deviation 10.18 |
| Placebo | Mean Change From Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) Total Score Over Week 10 | Week 10 | 29.8 Score on scale | Standard Deviation 23.46 |
| GSK372475 | Mean Change From Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) Total Score Over Week 10 | Week 4 | 15.4 Score on scale | Standard Deviation 17.68 |
| GSK372475 | Mean Change From Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) Total Score Over Week 10 | Week 1 | 5.7 Score on scale | Standard Deviation 12.23 |
| GSK372475 | Mean Change From Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) Total Score Over Week 10 | Week 10 | 31.8 Score on scale | Standard Deviation 23.25 |
| Paroxetine | Mean Change From Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) Total Score Over Week 10 | Week 1 | 4.9 Score on scale | Standard Deviation 12.02 |
| Paroxetine | Mean Change From Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) Total Score Over Week 10 | Week 10 | 34.3 Score on scale | Standard Deviation 21.07 |
| Paroxetine | Mean Change From Randomization in the Motivation and Energy Inventory (MEI) 18-Item Short Form (SF) Total Score Over Week 10 | Week 4 | 18.4 Score on scale | Standard Deviation 18.14 |
Comparison: Placebo versus GSK372475 in MEI total score at Week 10.p-value: 0.51690% CI: [-2.71, 6.24]MMRM
Comparison: Placebo versus Paroxetine in MEI total score at Week 10.p-value: 0.01690% CI: [1.97, 10.48]MMRM
Secondary
Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10
CSSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both behaviour and ideation. For SB scale, participants were scored as non-suicidal (00), preparatory acts or behavior communicating ideation (01), aborted attempt (02), interrupted attempt (03) or actual attempt (04) based on the most severe score (4 being the most severe). On SI scale, participants were scored as non-suicidal (00), wish to be dead (01), non-specific active suicidal thoughts (02), active suicidal ideation with associated thoughts of methods without intent (03), active suicidal ideation with some intent to act on suicidal thoughts without clear plan (04), active suicidal ideation with plan and intent (05), based on the most severe score (5 being the most severe). For both subscales, 0 indicated absence of symptom and higher score indicated greater severity of symptom. Only those scores for which at least one participant was reported are summarized.
Time frame: Up to Week 10
Population: ITT Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 1 | 150 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 5 | 3 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 2 | 7 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 8 | 3 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 5 | 123 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 2 | 2 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 6 | 132 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 4 | 2 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 2 | 3 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 10 | 2 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 4 | 0 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 04, Week 2 | 0 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 8 | 112 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 4 | 1 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 3 | 137 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 8 | 116 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 4 | 137 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 3 | 1 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 3 | 139 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 3 | 0 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 3 | 1 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 6 | 1 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 10 | 120 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 10 | 0 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 6 | 0 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 1 | 130 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 10 | 118 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 6 | 3 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 1 | 14 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 4 | 139 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 8 | 1 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 1 | 5 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 2 | 144 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 6 | 128 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 1 | 1 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 05, Week 8 | 0 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 5 | 3 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 04, Week 1 | 0 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 5 | 129 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 5 | 1 Participants |
| Placebo | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 2 | 132 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 6 | 112 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 1 | 168 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 2 | 154 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 3 | 146 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 4 | 140 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 5 | 125 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 6 | 117 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 8 | 105 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 10 | 101 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 1 | 148 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 1 | 17 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 1 | 1 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 1 | 1 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 04, Week 1 | 1 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 2 | 138 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 2 | 11 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 2 | 4 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 2 | 1 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 04, Week 2 | 1 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 3 | 135 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 3 | 8 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 3 | 2 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 3 | 1 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 4 | 126 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 4 | 10 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 4 | 4 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 4 | 0 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 5 | 119 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 5 | 5 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 5 | 1 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 5 | 0 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 6 | 5 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 6 | 1 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 6 | 0 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 8 | 103 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 8 | 2 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 8 | 0 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 05, Week 8 | 0 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 10 | 100 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 10 | 1 Participants |
| GSK372475 | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 10 | 0 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 2 | 148 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 8 | 0 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 5 | 2 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 04, Week 1 | 0 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 4 | 148 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 5 | 1 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 1 | 1 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 10 | 1 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 5 | 1 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 1 | 1 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 1 | 8 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 6 | 134 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 1 | 156 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 05, Week 8 | 1 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 6 | 1 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 10 | 130 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 3 | 151 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 6 | 0 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 8 | 133 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 1 | 166 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 6 | 2 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 6 | 136 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 3 | 1 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 3 | 4 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 10 | 128 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 3 | 1 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 3 | 145 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 8 | 130 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 4 | 143 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 04, Week 2 | 0 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 5 | 141 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 4 | 2 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 2 | 1 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SB, Score 00, Week 2 | 154 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 4 | 2 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 2 | 2 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 8 | 3 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 03, Week 4 | 1 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 01, Week 2 | 3 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 02, Week 10 | 1 Participants |
| Paroxetine | Number of Participants With Most Severe Suicidal Behaviour and Ideation in the Suicidal Behavior (SB) and Suicidal Ideation (SI) Subscales of the Columbia Suicide Severity Rating Scale (CSSRS) Over Week 10 | SI, Score 00, Week 5 | 137 Participants |
Secondary
Percentage of Participants Satisfied With Study Medication at Week 10
Participants were asked complete the participant Satisfaction with Study Medication question at Week 10 (or early withdrawal). Satisfaction was measured using a single 7-point Likert scale from 1 to 7 where higher scores indicate greater satisfaction with study medication. A score of 1 represents very dissatisfied, whilst a score of 7 represents very satisfied. Participants were categorized as a responder if they are rated either as 6 Satisfied or 7 Very Satisfied. The proportion of responders as percentage of participants based on the participant satisfaction with study medication item was defined as: number of participants with a response of 6 or 7 at the visit divided by number of participants with a satisfaction with study medication assessment at that visit (the sum of responders and non-responders) multiplied by 100.
Time frame: Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Satisfied With Study Medication at Week 10 | 45 Percentage of participants |
| GSK372475 | Percentage of Participants Satisfied With Study Medication at Week 10 | 46 Percentage of participants |
| Paroxetine | Percentage of Participants Satisfied With Study Medication at Week 10 | 64 Percentage of participants |
Comparison: Placebo versus GSK372475 in percentage of participants Satisfied with Study Medication at Week 10.p-value: 0.878290% CI: [0.62, 1.5]Regression, Logistic
Comparison: Placebo versus Paroxetine in percentage of participants Satisfied with Study Medication at Week 10.p-value: 0.001190% CI: [1.56, 3.86]Regression, Logistic
Secondary
Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10
The CGI-I scale measures the improvement of psychiatric symptoms on a 7-point scale from 1-7. The scale was rated by the clinician at every visit during the treatment phase (Week 1 through Week 10/early withdrawal) of the participant's total improvement or worsening compared with that individual's condition at the start of the study (the Randomization visit , Week 0) whether or not the change is judged to be due to drug treatment. The scores indicated the following: 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; 7= very much worse. The score ranged from 1-7, where 1 indicated very much improved and higher score indicated greater severity of symptoms. Randomization value was defined as the assessment value done on Week 0. Data is reported for the percentage of participants who were much improved and very much improved.
Time frame: Up to Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 1 | 3 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 2 | 12 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 3 | 28 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 4 | 40 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 5 | 45 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 6 | 59 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 8 | 61 Percentage of participants |
| Placebo | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 10 | 62 Percentage of participants |
| GSK372475 | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 3 | 27 Percentage of participants |
| GSK372475 | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 8 | 69 Percentage of participants |
| GSK372475 | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 4 | 36 Percentage of participants |
| GSK372475 | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 5 | 48 Percentage of participants |
| GSK372475 | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 6 | 59 Percentage of participants |
| GSK372475 | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 1 | 4 Percentage of participants |
| GSK372475 | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 2 | 17 Percentage of participants |
| GSK372475 | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 10 | 75 Percentage of participants |
| Paroxetine | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 3 | 41 Percentage of participants |
| Paroxetine | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 2 | 20 Percentage of participants |
| Paroxetine | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 1 | 5 Percentage of participants |
| Paroxetine | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 4 | 49 Percentage of participants |
| Paroxetine | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 8 | 83 Percentage of participants |
| Paroxetine | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 6 | 77 Percentage of participants |
| Paroxetine | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 5 | 66 Percentage of participants |
| Paroxetine | Percentage of Participants With Clinical Global Impression - Global Improvement (CGI-I) Over Week 10 | Week 10 | 82 Percentage of participants |
Comparison: Placebo versus GSK372475 in percentage of participants with CGI-I at Week 1.p-value: 0.692890% CI: [0.44, 3.76]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in percentage of participants with CGI-I at Week 1.p-value: 0.303990% CI: [0.69, 5.01]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in percentage of participants with CGI-I at Week 2.p-value: 0.193890% CI: [0.89, 2.7]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in percentage of participants with CGI-I at Week 2.p-value: 0.0690% CI: [1.08, 3.16]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in percentage of participants with CGI-I at Week 3.p-value: 0.898990% CI: [0.61, 1.53]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in percentage of participants with CGI-I at Week 3.p-value: 0.013690% CI: [1.25, 3.05]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in percentage of participants with CGI-I at Week 4.p-value: 0.309990% CI: [0.5, 1.18]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in percentage of participants with CGI-I at Week 4.p-value: 0.113790% CI: [0.98, 2.27]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in percentage of participants with CGI-I at Week 5.p-value: 0.868290% CI: [0.67, 1.64]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in percentage of participants with CGI-I at Week 5.p-value: 0.000690% CI: [1.63, 4.03]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in percentage of participants with CGI-I at Week 6.p-value: 0.899290% CI: [0.62, 1.51]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in percentage of participants with CGI-I at Week 6.p-value: 0.000490% CI: [1.67, 4.09]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in percentage of participants with CGI-I at Week 8.p-value: 0.2890% CI: [0.85, 2.23]Placebo versus GSK372475 in percentage o
Comparison: Placebo versus Paroxetine in percentage of participants with CGI-I at Week 8.p-value: 090% CI: [2.24, 6.08]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in percentage of participants with CGI-I at Week 10.p-value: 0.050790% CI: [1.1, 3.13]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in percentage of participants with CGI-I at Week 10.p-value: 0.000390% CI: [1.81, 4.88]Generalized estimating equation model
Secondary
Percentage of Responders and Remitters of HAMD-17 Over Week 10
HAMD-17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAMD-17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges from 0 to 52, where 0 indicates absence of symptom and higher scores indicates more severe symptoms. Responders were defined as participants who had a \>=50% reduction from randomization in HAMD-17 total Score. Percentage change from randomization was calculated as total score at post Randomization visit minus total score at Randomization visit divided by total score at Randomization visit multiplied by 100. Remitters were defined as participants with a HAMD-17 total score \<=7.
Time frame: Up to Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 5 | 16 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 10 | 51 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 3 | 16 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 4 | 17 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 1 | 2 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 10 | 35 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 3 | 7 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 2 | 3 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 5 | 29 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 2 | 8 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 8 | 28 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 6 | 36 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 1 | 3 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 6 | 23 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 8 | 41 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 4 | 25 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 4 | 9 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 3 | 14 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 4 | 14 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 5 | 30 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 6 | 33 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 8 | 48 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 10 | 55 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 1 | 2 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 2 | 5 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 3 | 8 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 2 | 10 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 5 | 15 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 6 | 20 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 8 | 29 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 10 | 39 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 1 | 2 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 8 | 62 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 10 | 52 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 5 | 26 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 6 | 54 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 3 | 25 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 6 | 40 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 5 | 42 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 2 | 14 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 8 | 45 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 2 | 9 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 1 | 2 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 4 | 32 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 3 | 15 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 10 | 72 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Responders, Week 1 | 4 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of HAMD-17 Over Week 10 | Remitters, Week 4 | 16 Percentage of participants |
Comparison: Placebo versus GSK372475 in HAMD-17 responders at Week 1.p-value: 0.505790% CI: [0.2, 1.98]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 responders at Week 1.p-value: 0.863390% CI: [0.38, 3.3]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 responders at Week 2.p-value: 0.842890% CI: [0.55, 2.16]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 responders at Week 2.p-value: 0.341690% CI: [0.76, 2.84]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 responders at Week 3.p-value: 0.328790% CI: [0.4, 1.26]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 responders at Week 3.p-value: 0.211290% CI: [0.88, 2.57]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 responders at Week 4.p-value: 0.013490% CI: [0.26, 0.76]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 responders at Week 4.p-value: 0.341290% CI: [0.81, 2.17]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 responders at Week 5.p-value: 0.843490% CI: [0.58, 1.54]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 responders at Week 5.p-value: 0.081990% CI: [1.03, 2.63]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 responders at Week 6.p-value: 0.283290% CI: [0.44, 1.19]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 responders at Week 6.p-value: 0.001690% CI: [1.54, 3.97]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 responders at Week 8.p-value: 0.972790% CI: [0.6, 1.63]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 responders at Week 8.p-value: 0.00190% CI: [1.6, 4.13]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 responders at Week 10.p-value: 0.831290% CI: [0.64, 1.8]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 responders at Week 10.p-value: 0.000290% CI: [1.86, 5.02]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 remitters at Week 1.p-value: 0.55390% CI: [0.13, 2.6]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 remitters at Week 1.p-value: 0.97890% CI: [0.28, 3.41]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 remitters at Week 2.p-value: 0.831290% CI: [0.43, 3.03]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 remitters at Week 2.p-value: 0.188190% CI: [0.83, 5.25]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 remitters at Week 3.p-value: 0.638490% CI: [0.39, 1.69]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 remitters at Week 3.p-value: 0.21690% CI: [0.84, 3.37]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 remitters at Week 4.p-value: 0.025990% CI: [0.2, 0.79]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 remitters at Week 4.p-value: 0.395990% CI: [0.39, 1.35]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 remitters at Week 5.p-value: 0.385790% CI: [0.39, 1.34]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 remitters at Week 5.p-value: 0.312690% CI: [0.8, 2.52]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 remitters at Week 6.p-value: 0.118290% CI: [0.36, 1.03]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 remitters at Week 6.p-value: 0.012590% CI: [1.29, 3.43]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 remitters at Week 8.p-value: 0.214790% CI: [0.42, 1.13]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 remitters at Week 8.p-value: 0.078390% CI: [1.03, 2.69]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in HAMD-17 remitters at Week 10.p-value: 0.906790% CI: [0.57, 1.64]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in HAMD-17 remitters at Week 10.p-value: 0.032890% CI: [1.15, 2.92]Generalized estimating equation model
Secondary
Percentage of Responders and Remitters of IDS-CR Over Week 10
IDS-CR is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms. The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Total score of IDS-CR calculated as : either item 11 or 12 scored; either item 13 or 14 scored; if both items scored, the highest of the items was used. Total score was obtained by adding the scores of 28 items of the 30 items. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Responders were defined as participants who had a \>=50% reduction from randomization in IDS-CR total Score. Percentage change from randomization was calculated as total score at post Randomization visit minus total score at Randomization visit divided by total score at Randomization visit multiplied by 100. Remitters were defined as participants with a IDS-CR total score \<=14.
Time frame: Up to Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 5 | 28 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 2 | 8 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 3 | 17 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 4 | 25 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 1 | 4 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 6 | 36 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 8 | 43 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 10 | 50 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 1 | 3 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 2 | 3 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 3 | 8 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 4 | 17 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 5 | 16 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 6 | 22 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 8 | 28 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 10 | 35 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 6 | 37 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 8 | 50 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 10 | 60 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 6 | 21 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 1 | 1 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 2 | 8 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 10 | 38 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 3 | 8 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 1 | 3 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 8 | 31 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 2 | 11 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 4 | 10 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 3 | 15 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 4 | 17 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 5 | 31 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 5 | 18 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 3 | 13 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 6 | 58 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 5 | 27 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 3 | 26 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 8 | 62 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 10 | 48 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 1 | 5 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 10 | 72 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 4 | 16 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 5 | 44 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 1 | 1 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 6 | 40 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 2 | 14 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 2 | 8 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Responders, Week 4 | 33 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of IDS-CR Over Week 10 | Remitters, Week 8 | 44 Percentage of participants |
Comparison: Placebo versus GSK372475 in IDS-CR responders at Week 1.p-value: 0.507290% CI: [0.22, 1.89]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR responders at Week 1.p-value: 0.688690% CI: [0.52, 2.93]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR responders at Week 2.p-value: 0.866490% CI: [0.56, 2.04]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR responders at Week 2.p-value: 0.289790% CI: [0.8, 2.79]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR responders at Week 3.p-value: 0.247490% CI: [0.39, 1.18]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR responders at Week 3.p-value: 0.200790% CI: [0.89, 2.47]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR responders at Week 4.p-value: 0.021490% CI: [0.29, 0.82]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR responders at Week 4.p-value: 0.236890% CI: [0.88, 2.23]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR responders at Week 5.p-value: 0.98790% CI: [0.63, 1.59]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR responders at Week 5.p-value: 0.019390% CI: [1.21, 3]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR responders at Week 6.p-value: 0.835190% CI: [0.59, 1.5]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR responders at Week 6.p-value: 0.000190% CI: [1.9, 4.77]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR responders at Week 8.p-value: 0.75190% CI: [0.67, 1.8]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR responders at Week 8.p-value: 0.002990% CI: [1.47, 3.8]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR responders at Week 10.p-value: 0.170790% CI: [0.92, 2.55]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR responders at Week 10.p-value: 0.000190% CI: [1.99, 5.36]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR remitters at Week 1.p-value: 0.20590% CI: [0.05, 1.48]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR remitters at Week 1.p-value: 0.173590% CI: [0.11, 1.24]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR remitters at Week 2.p-value: 0.230590% CI: [0.78, 4.75]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR remitters at Week 2.p-value: 0.250790% CI: [0.77, 4.5]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR remitters at Week 3.p-value: 0.560890% CI: [0.35, 1.64]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR remitters at Week 3.p-value: 0.652690% CI: [0.6, 2.42]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR remitters at Week 4.p-value: 0.020890% CI: [0.21, 0.77]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR remitters at Week 4.p-value: 0.285990% CI: [0.39, 1.22]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR remitters at Week 5.p-value: 0.792190% CI: [0.49, 1.66]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR remitters at Week 5.p-value: 0.36290% CI: [0.79, 2.31]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR remitters at Week 6.p-value: 0.433190% CI: [0.44, 1.34]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR remitters at Week 6.p-value: 0.004790% CI: [1.42, 3.75]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR remitters at Week 8.p-value: 0.443190% CI: [0.46, 1.32]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR remitters at Week 8.p-value: 0.190190% CI: [0.9, 2.44]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in IDS-CR remitters at Week 10.p-value: 0.922290% CI: [0.56, 1.66]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in IDS-CR remitters at Week 10.p-value: 0.166590% CI: [0.93, 2.43]Generalized estimating equation model
Secondary
Percentage of Responders and Remitters of MADRS Over Week 10
The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The total score ranged from 0-60, where 0 indicated no depression and 60 indicated severely depressed. Responders were defined as participants who had a \>=50% reduction from randomization in MADRS total Score. Percentage change from randomization was calculated as total score at post Randomization visit minus total score at Randomization visit divided by total score at Randomization visit multiplied by 100. Remitters were defined as participants with a MADRS total score \<=11.
Time frame: Up to Week 10
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 6 | 40 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 5 | 17 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 8 | 35 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 8 | 44 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 4 | 18 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 3 | 20 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 10 | 55 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 5 | 35 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 10 | 45 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 1 | 2 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 1 | 3 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 2 | 5 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 6 | 28 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 4 | 29 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 3 | 12 Percentage of participants |
| Placebo | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 2 | 8 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 3 | 10 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 4 | 12 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 5 | 24 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 6 | 33 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 5 | 35 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 8 | 41 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 2 | 11 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 10 | 52 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 1 | 3 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 6 | 41 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 1 | 3 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 8 | 54 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 10 | 64 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 3 | 14 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 2 | 7 Percentage of participants |
| GSK372475 | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 4 | 17 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 10 | 68 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 1 | 4 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 2 | 13 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 3 | 25 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 4 | 35 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 5 | 51 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 6 | 63 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 8 | 72 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Responders, Week 10 | 81 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 1 | 3 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 2 | 11 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 3 | 17 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 4 | 22 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 5 | 38 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 6 | 48 Percentage of participants |
| Paroxetine | Percentage of Responders and Remitters of MADRS Over Week 10 | Remitters, Week 8 | 55 Percentage of participants |
Comparison: Placebo versus GSK372475 in MADRS responders at Week 1.p-value: 0.506190% CI: [0.21, 1.93]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS responders at Week 1.p-value: 0.739890% CI: [0.46, 3.25]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS responders at Week 2.p-value: 0.920990% CI: [0.52, 2.08]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS responders at Week 2.p-value: 0.290890% CI: [0.78, 3.13]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS responders at Week 3.p-value: 0.008690% CI: [0.23, 0.72]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS responders at Week 3.p-value: 0.808790% CI: [0.64, 1.83]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS responders at Week 4.p-value: 0.000290% CI: [0.18, 0.52]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS responders at Week 4.p-value: 0.460690% CI: [0.78, 1.94]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS responders at Week 5.p-value: 0.139990% CI: [0.4, 1.05]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS responders at Week 5.p-value: 0.046190% CI: [1.1, 2.73]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS responders at Week 6.p-value: 0.1490% CI: [0.41, 1.05]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS responders at Week 6.p-value: 0.000290% CI: [1.74, 4.21]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS responders at Week 8.p-value: 0.959690% CI: [0.59, 1.64]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS responders at Week 8.p-value: 090% CI: [2.01, 5.23]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS responders at Week 10.p-value: 0.65390% CI: [0.69, 1.93]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS responders at Week 10.p-value: 090% CI: [2.11, 5.73]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS remitters at Week 1.p-value: 0.884490% CI: [0.23, 3.48]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS remitters at Week 1.p-value: 0.742590% CI: [0.36, 4.68]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS remitters at Week 2.p-value: 0.835590% CI: [0.39, 2.07]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS remitters at Week 2.p-value: 0.178690% CI: [0.86, 4.32]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS remitters at Week 3.p-value: 0.083590% CI: [0.26, 0.97]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS remitters at Week 3.p-value: 0.855890% CI: [0.58, 1.98]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS remitters at Week 4.p-value: 0.006790% CI: [0.2, 0.67]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS remitters at Week 4.p-value: 0.664790% CI: [0.67, 1.98]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS remitters at Week 5.p-value: 0.955390% CI: [0.55, 1.74]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS remitters at Week 5.p-value: 0.00490% CI: [1.5, 4.42]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS remitters at Week 6.p-value: 0.632790% CI: [0.52, 1.43]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS remitters at Week 6.p-value: 0.002790% CI: [1.47, 3.79]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS remitters at Week 8.p-value: 0.396190% CI: [0.45, 1.29]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS remitters at Week 8.p-value: 0.029890% CI: [1.17, 3.06]Generalized estimating equation model
Comparison: Placebo versus GSK372475 in MADRS remitters at Week 10.p-value: 0.882690% CI: [0.56, 1.61]Generalized estimating equation model
Comparison: Placebo versus Paroxetine in MADRS remitters at Week 10.p-value: 0.002290% CI: [1.52, 4.05]Generalized estimating equation model