Generalized Anxiety Disorder
Conditions
Keywords
PF 06372865, generalized anxiety disorder, outpatient, safety, efficacy, suboptimal response
Brief summary
This study aims to evaluate whether PF-06372865 is safe and effective in the treatment of sub-optimally controlled symptoms of generalized anxiety disorder during two 4-week treatment periods using a Sequential Parallel Comparison Design (SPCD). The study will use the Hamilton Anxiety Rating Scale (HAM-A) to measure change in symptoms from baseline for two doses of PF-06372865 compared to placebo.
Interventions
DRUGPF-06372865.
Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Outpatient males and females 18 65 years of age (inclusive). 2. Diagnostic and Statistical Manual of Mental Disorders Fourth edition Text Revised (DSM IV TR) diagnosis of GAD (DSM IV TR, 300.02), confirmed as primary diagnosis by the Mini international neuropsychiatric interview (MINI) structured interview. 3. All subjects must have a total HAM A (via SIGH A) score 22 at screening. In addition, scores at the baseline visit must also be within 20% of scores at screening. 4. Subjects must also have a Covi Anxiety Scale score of 9 and a Raskin Depression Scale score 7 at the Screening (Visit 1) visit to ensure predominance of anxiety symptoms over depression symptoms. 5. Taking an FDA approved GAD treatment (escitalopram 10 to 20 mg total daily dose, paroxetine 20 to 50 mg total daily dose, duloxetine 60 to 120 mg total daily dose, or venlafaxine 75 to 225 mg total daily dose) at a stable FDA approved dosage for at least the two consecutive months in the current episode immediately prior to the screening visit. Sertraline or citalopram are also permitted as background treatment for GAD at doses of 50 to 200 mg total daily dose and 20 to 40 mg total daily dose, respectively.
Exclusion criteria
1. Subjects with a history of daily benzodiazepine use within one month of the screening visit. 2. Recent (defined as meeting disorder diagnostic criteria during the last 6 months) of a DSM IV TR Axis I diagnosis other than generalized anxiety disorder, with the following exceptions: a. Subjects with recent (in the last 2 months) major depressive disorder may be enrolled if the anxiety symptoms are predominant over the depressive symptoms, as judged by the Covi/Raskin criteria listed above and confirmed GAD as the primary diagnosis by the MINI structured interview. b. Comorbid social phobia and/or specific phobias are permitted as long as the anxiety symptoms due to these disorders are clinically less significant than the anxiety symptoms due to GAD and GAD is confirmed as the primary diagnosis by the MINI structured interview. 3. Recent (defined as meeting disorder diagnostic criteria during the last 6 months) of a DSM IV TR Axis I of panic disorder with or without agoraphobia, Post Traumatic Stress Disorder (PTSD), dissociative disorder, obsessive compulsive disorder, attention deficit disorder. If a subject has a past misdiagnosis of any of these disorders, or if the subject has another psychiatric disorder that in the opinion of the investigator affects the suitability of a subject for this study based on safety or other considerations, the investigator will need to contact the sponsor prior to screening. 4. Past and/or current DSM IV TR diagnosis of schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive disorder (including delirium, dementia, and amnestic disorder). 5. Presence of comorbid personality disorders (Axis II) based on DSM IV TR. 6. Subjects who meet DSM IV TR defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM IV TR defined substance abuse within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2 | Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28) | The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. |
| Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1 | Week 4 | The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. |
| Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2 | Stage 1: Week 4, Stage 2: Week 8 | The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1 | Week 1, 2, 3 | The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. |
| Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2 | Stage 1: Week 4, Stage 2: Week 8 | A responder was defined as a participant with \>= to 50 percent decrease in their total HAM-A score from baseline to the last week in the stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. Percentage of responders of total HMA scale were reported. |
| Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8) | CGI-I was a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score indicated more affected. Change is equal to score at observation minus score at baseline. |
| Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8) | The CGI-S consisted of a single 7-point rating score of illness severity, was completed by a clinician. Raters selected one response based on the following question, Considering your total clinical experience with that particular population, how mentally ill was your participant at that time? Scores were: 1 (normal, not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill) 6 (severely ill) or 7 (among the most severely ill participants). Higher scores indicate more severity. |
| Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | Week 5, 6, 7, 8 | The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. |
| Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 6, 7, 8 | Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. |
| Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8) | The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Psychic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety. |
| Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8) | The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Somatic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety. |
| Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores | Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8 | Percentage of participants with HAM-A total score less than or equal to 7 in the last week of the Stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. |
| Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 2, 3, 4 | Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 nanogram per milliliter (ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0. |
| Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28) | SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment. |
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Stage 1: Week 4, Stage 2: Week 8 | SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment. |
Countries
United States
Participant flow
Pre-assignment details
This was a sequential parallel study consisting of 2 stages: 4 week randomized treatment period (Stage 1) followed by a 4 week treatment period (Stage 2). Participants randomized to placebo for Stage 1, received either PF-06372865 or placebo in Stage 2 and participants randomized to PF-06372865 in Stage 1 were assigned to Placebo in Stage 2.
Participants by arm
| Arm | Count |
|---|---|
| Placebo + Placebo Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2. | 15 |
| Placebo + PF-06372865 2.5 mg Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 2. | 15 |
| Placebo + PF-06372865 7.5 mg Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2. | 15 |
| PF-06372865 2.5 mg + Placebo Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2. | 24 |
| PF-06372865 7.5 mg + Placebo Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2. | 21 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Stage 1 ( 4 Weeks) | Adverse Event | 1 | 1 | 1 | 0 | 0 |
| Stage 1 ( 4 Weeks) | Lack of Efficacy | 0 | 0 | 0 | 0 | 1 |
| Stage 1 ( 4 Weeks) | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
| Stage 1 ( 4 Weeks) | No Longer Meets Eligibility Criteria | 0 | 0 | 0 | 1 | 0 |
| Stage 1 ( 4 Weeks) | Other | 1 | 1 | 0 | 0 | 0 |
| Stage 1 ( 4 Weeks) | Withdrawal by Participants | 1 | 0 | 0 | 0 | 0 |
| Stage 2 (4 Weeks) | Adverse Event | 0 | 0 | 0 | 1 | 1 |
| Stage 2 (4 Weeks) | Lost to Follow-up | 0 | 0 | 0 | 2 | 0 |
| Stage 2 (4 Weeks) | Other | 0 | 1 | 1 | 0 | 0 |
| Stage 2 (4 Weeks) | Protocol Violation | 0 | 0 | 0 | 1 | 0 |
| Stage 2 (4 Weeks) | Withdrawal by Participants | 1 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo + Placebo | Placebo + PF-06372865 2.5 mg | Placebo + PF-06372865 7.5 mg | PF-06372865 2.5 mg + Placebo | PF-06372865 7.5 mg + Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 36.5 years STANDARD_DEVIATION 12.4 | 47.1 years STANDARD_DEVIATION 15.6 | 42.7 years STANDARD_DEVIATION 13.8 | 38.8 years STANDARD_DEVIATION 14 | 42 years STANDARD_DEVIATION 12 | 41.2 years STANDARD_DEVIATION 13.7 |
| Gender Female | 11 Participants | 9 Participants | 10 Participants | 19 Participants | 18 Participants | 67 Participants |
| Gender Male | 4 Participants | 6 Participants | 5 Participants | 5 Participants | 3 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 27 / 87 | 13 / 37 | 16 / 35 |
| serious Total, serious adverse events | 1 / 87 | 0 / 37 | 0 / 35 |
Outcome results
Primary
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1
The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Time frame: Week 4
Population: Full analysis set for Stage 1 included all randomized participants who had received at least 1 dose of randomized treatment. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1 | -10.5 units on a scale | Standard Error 1.16 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1 | -7.9 units on a scale | Standard Error 1.54 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1 | -9.9 units on a scale | Standard Error 1.62 |
Comparison: (PF-06372865 7.5 mg - Placebo). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.p-value: 0.78490% CI: [-2.8, 3.9]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.p-value: 0.18490% CI: [-0.6, 5.8]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.p-value: 0.3690% CI: [-5.7, 1.6]Mixed-Effects Model Repeated Measure
Primary
Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2
The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Time frame: Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)
Population: Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) with less than (\<) 50% reduction in HAM-A during Stage 1 baseline,Week 4 and HAM-A value of greater than or equal to (\>=)16 at Week 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Stage 1) | Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2 | 28 units on a scale | Standard Deviation 4.48 |
| PF-06372865 2.5 mg (Stage 1) | Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2 | 26.7 units on a scale | Standard Deviation 4.27 |
| PF-06372865 7.5 mg (Stage 1) | Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2 | 26.1 units on a scale | Standard Deviation 4 |
| Placebo (Stage 2) | Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2 | 26.2 units on a scale | Standard Deviation 6.91 |
| PF-06372865 2.5 mg (Stage 2) | Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2 | 22.5 units on a scale | Standard Deviation 4.24 |
| PF-06372865 7.5 mg (Stage 2) | Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2 | 22.5 units on a scale | Standard Deviation 4.63 |
Primary
Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2
The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Time frame: Stage 1: Week 4, Stage 2: Week 8
Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Stage 1) | Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2 | 17.5 units on a scale | Standard Deviation 8.03 |
| PF-06372865 2.5 mg (Stage 1) | Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2 | 18.7 units on a scale | Standard Deviation 9.49 |
| PF-06372865 7.5 mg (Stage 1) | Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2 | 16.5 units on a scale | Standard Deviation 6.87 |
| Placebo (Stage 2) | Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2 | 21.7 units on a scale | Standard Deviation 9.44 |
| PF-06372865 2.5 mg (Stage 2) | Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2 | 15.5 units on a scale | Standard Deviation 7.01 |
| PF-06372865 7.5 mg (Stage 2) | Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2 | 19.4 units on a scale | Standard Deviation 8.44 |
Secondary
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2
CGI-I was a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score indicated more affected. Change is equal to score at observation minus score at baseline.
Time frame: Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)
Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W3, S2: W7 (n=39,21,21,6,8,7) | -1.0 units on a scale | Standard Deviation 0.99 |
| Placebo (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W1, S2: W5 (n=41,23,21,6,8,8) | -0.4 units on a scale | Standard Deviation 0.89 |
| Placebo (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Baseline : S1, S2 (n=45,23,21,6,8,8) | 3.8 units on a scale | Standard Deviation 0.53 |
| Placebo (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W4, S2: W8 (n=40,21,20,6,8,7) | -1.1 units on a scale | Standard Deviation 1.06 |
| Placebo (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W2, S2: W6 (n=39,22,21,6,8,8) | -0.6 units on a scale | Standard Deviation 0.91 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W1, S2: W5 (n=41,23,21,6,8,8) | -0.6 units on a scale | Standard Deviation 1.04 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W3, S2: W7 (n=39,21,21,6,8,7) | -0.9 units on a scale | Standard Deviation 1.2 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Baseline : S1, S2 (n=45,23,21,6,8,8) | 3.8 units on a scale | Standard Deviation 0.74 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W4, S2: W8 (n=40,21,20,6,8,7) | -1.0 units on a scale | Standard Deviation 1.24 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W2, S2: W6 (n=39,22,21,6,8,8) | -0.7 units on a scale | Standard Deviation 1.17 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W1, S2: W5 (n=41,23,21,6,8,8) | -0.5 units on a scale | Standard Deviation 0.87 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W3, S2: W7 (n=39,21,21,6,8,7) | -1.1 units on a scale | Standard Deviation 1.01 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W4, S2: W8 (n=40,21,20,6,8,7) | -1.1 units on a scale | Standard Deviation 1.05 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W2, S2: W6 (n=39,22,21,6,8,8) | -0.9 units on a scale | Standard Deviation 1.11 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Baseline : S1, S2 (n=45,23,21,6,8,8) | 3.9 units on a scale | Standard Deviation 0.36 |
| Placebo (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W2, S2: W6 (n=39,22,21,6,8,8) | -0.5 units on a scale | Standard Deviation 1.22 |
| Placebo (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Baseline : S1, S2 (n=45,23,21,6,8,8) | 3.5 units on a scale | Standard Deviation 0.55 |
| Placebo (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W1, S2: W5 (n=41,23,21,6,8,8) | -0.2 units on a scale | Standard Deviation 0.98 |
| Placebo (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W3, S2: W7 (n=39,21,21,6,8,7) | -0.7 units on a scale | Standard Deviation 1.03 |
| Placebo (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W4, S2: W8 (n=40,21,20,6,8,7) | -0.5 units on a scale | Standard Deviation 1.38 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W3, S2: W7 (n=39,21,21,6,8,7) | -0.8 units on a scale | Standard Deviation 1.16 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Baseline : S1, S2 (n=45,23,21,6,8,8) | 3.3 units on a scale | Standard Deviation 0.71 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W4, S2: W8 (n=40,21,20,6,8,7) | -1.0 units on a scale | Standard Deviation 1.2 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W1, S2: W5 (n=41,23,21,6,8,8) | -0.5 units on a scale | Standard Deviation 1.2 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W2, S2: W6 (n=39,22,21,6,8,8) | -0.3 units on a scale | Standard Deviation 1.16 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Baseline : S1, S2 (n=45,23,21,6,8,8) | 3.0 units on a scale | Standard Deviation 0.76 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W3, S2: W7 (n=39,21,21,6,8,7) | 0.0 units on a scale | Standard Deviation 0.58 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W1, S2: W5 (n=41,23,21,6,8,8) | 0.3 units on a scale | Standard Deviation 0.46 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W4, S2: W8 (n=40,21,20,6,8,7) | -0.3 units on a scale | Standard Deviation 0.76 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W2, S2: W6 (n=39,22,21,6,8,8) | 0.1 units on a scale | Standard Deviation 0.64 |
Comparison: (PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.80190% CI: [-0.4, 0.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.41690% CI: [-0.5, 0.2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.63490% CI: [-0.3, 0.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.4790% CI: [-0.6, 0.2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.68390% CI: [-0.5, 0.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.77590% CI: [-0.5, 0.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.84890% CI: [-0.4, 0.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.4990% CI: [-0.2, 0.6]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.43390% CI: [-0.7, 0.2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.79690% CI: [-0.4, 0.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.62490% CI: [-0.3, 0.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.84490% CI: [-0.5, 0.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.74390% CI: [-0.7, 1]LS Mean Difference
Comparison: (PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.35690% CI: [-1.3, 0.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.1890% CI: [-0.2, 1.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.58990% CI: [-0.6, 1.2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.87390% CI: [-0.8, 1]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.66790% CI: [-0.6, 1]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.54890% CI: [-0.5, 1.1]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.56790% CI: [-1, 0.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.20890% CI: [-0.2, 1.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.85890% CI: [-1.2, 0.9]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.32990% CI: [-1.7, 0.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.27290% CI: [-0.4, 1.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.p-value: 0.94690% CI: [-0.6, 0.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.p-value: 0.40790% CI: [-0.8, 0.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.p-value: 0.43690% CI: [-0.3, 0.8]Mixed-Effects Model Repeated Measure
Secondary
Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2
The CGI-S consisted of a single 7-point rating score of illness severity, was completed by a clinician. Raters selected one response based on the following question, Considering your total clinical experience with that particular population, how mentally ill was your participant at that time? Scores were: 1 (normal, not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill) 6 (severely ill) or 7 (among the most severely ill participants). Higher scores indicate more severity.
Time frame: Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)
Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W1, S2: W5 (n=41,24,21,6,8,8) | -0.5 units on a scale | Standard Deviation 0.78 |
| Placebo (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 4.8 units on a scale | Standard Deviation 0.63 |
| Placebo (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -0.8 units on a scale | Standard Deviation 0.9 |
| Placebo (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -1.3 units on a scale | Standard Deviation 1.16 |
| Placebo (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -1.2 units on a scale | Standard Deviation 1.12 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -0.7 units on a scale | Standard Deviation 1.01 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W1, S2: W5 (n=41,24,21,6,8,8) | -0.5 units on a scale | Standard Deviation 0.93 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 4.6 units on a scale | Standard Deviation 0.58 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -1.0 units on a scale | Standard Deviation 1.21 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -1.0 units on a scale | Standard Deviation 1.21 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -1.0 units on a scale | Standard Deviation 1.07 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -1.4 units on a scale | Standard Deviation 0.98 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -1.3 units on a scale | Standard Deviation 1.08 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 4.8 units on a scale | Standard Deviation 0.54 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W1, S2: W5 (n=41,24,21,6,8,8) | -0.7 units on a scale | Standard Deviation 0.72 |
| Placebo (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W1, S2: W5 (n=41,24,21,6,8,8) | 0.0 units on a scale | Standard Deviation 1.1 |
| Placebo (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -0.5 units on a scale | Standard Deviation 1.87 |
| Placebo (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -0.8 units on a scale | Standard Deviation 1.33 |
| Placebo (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -0.5 units on a scale | Standard Deviation 1.64 |
| Placebo (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 4.5 units on a scale | Standard Deviation 1.05 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | 0.0 units on a scale | Standard Deviation 0.93 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W1, S2: W5 (n=41,24,21,6,8,8) | -0.1 units on a scale | Standard Deviation 0.99 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 4.3 units on a scale | Standard Deviation 0.89 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -1.0 units on a scale | Standard Deviation 0.93 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -1.1 units on a scale | Standard Deviation 0.83 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -0.3 units on a scale | Standard Deviation 0.49 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -0.6 units on a scale | Standard Deviation 0.79 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W1, S2: W5 (n=41,24,21,6,8,8) | 0.0 units on a scale | Standard Deviation 0.53 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 4.0 units on a scale | Standard Deviation 0.76 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -0.1 units on a scale | Standard Deviation 0.64 |
Comparison: (PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.p-value: 0.32590% CI: [-0.6, 0.1]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.99690% CI: [-0.3, 0.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.37790% CI: [-0.6, 0.2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.29190% CI: [-0.7, 0.1]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.92590% CI: [-0.4, 0.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.3990% CI: [-0.7, 0.2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.50290% CI: [-0.7, 0.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.34890% CI: [-0.2, 0.7]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.1690% CI: [-1, 0.1]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.96590% CI: [-0.5, 0.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.38990% CI: [-0.2, 0.7]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.43390% CI: [-0.8, 0.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.9490% CI: [-0.9, 0.8]LS Mean Difference
Comparison: (PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.75790% CI: [-1, 0.7]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.83690% CI: [-0.7, 0.9]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.82790% CI: [-0.9, 1.1]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.50790% CI: [-0.6, 1.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.63290% CI: [-1.1, 0.6]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.44290% CI: [-0.5, 1.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.64390% CI: [-1.1, 0.6]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.18890% CI: [-0.2, 1.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.70190% CI: [-1.4, 0.9]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.27190% CI: [-1.8, 0.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.44590% CI: [-0.6, 1.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.p-value: 0.71490% CI: [-0.8, 0.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.p-value: 0.51590% CI: [-0.8, 0.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.p-value: 0.77890% CI: [-0.5, 0.7]Mixed-Effects Model Repeated Measure
Secondary
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1
The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Time frame: Week 1, 2, 3
Population: Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1 | Week 1 (n= 41,24,21) | -6.0 units on a scale | Standard Error 0.84 |
| Placebo (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1 | Week 3 (n= 39,22,21) | -10.2 units on a scale | Standard Error 1 |
| Placebo (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1 | Week 2 (n= 39,23,21) | -6.9 units on a scale | Standard Error 1.05 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1 | Week 2 (n= 39,23,21) | -6.3 units on a scale | Standard Error 1.37 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1 | Week 3 (n= 39,22,21) | -8.6 units on a scale | Standard Error 1.32 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1 | Week 1 (n= 41,24,21) | -5.3 units on a scale | Standard Error 1.09 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1 | Week 2 (n= 39,23,21) | -7.7 units on a scale | Standard Error 1.45 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1 | Week 3 (n= 39,22,21) | -9.2 units on a scale | Standard Error 1.38 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1 | Week 1 (n= 41,24,21) | -5.7 units on a scale | Standard Error 1.18 |
Comparison: (PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.p-value: 0.85690% CI: [-2.2, 2.7]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.p-value: 0.64790% CI: [-1.7, 2.9]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.p-value: 0.81790% CI: [-3, 2.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.p-value: 0.6790% CI: [-3.8, 2.2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.p-value: 0.73690% CI: [-2.3, 3.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.p-value: 0.49690% CI: [-4.7, 2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.p-value: 0.57590% CI: [-1.9, 3.8]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.p-value: 0.36290% CI: [-1.2, 4.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.p-value: 0.77190% CI: [-3.7, 2.6]Mixed-Effects Model Repeated Measure
Secondary
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2
The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Time frame: Week 5, 6, 7, 8
Population: Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) \< 50 % reduction in HAM-A during Stage 1 baseline, Week 4 and HAM-A value of \>=16 at Week 4. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | Week 5 (n = 6, 8, 8) | -0.4 units on a scale | Standard Error 1.77 |
| Placebo (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | Week 6 (n = 6, 8, 8) | -3.3 units on a scale | Standard Error 2.25 |
| Placebo (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | Week 7 (n = 6, 8, 7) | -4.6 units on a scale | Standard Error 2.02 |
| Placebo (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | Week 8 (n = 6, 8, 7) | -4.1 units on a scale | Standard Error 2.92 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | Week 8 (n = 6, 8, 7) | -7.2 units on a scale | Standard Error 2.46 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | Week 5 (n = 6, 8, 8) | -1.5 units on a scale | Standard Error 1.49 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | Week 7 (n = 6, 8, 7) | -4.4 units on a scale | Standard Error 1.7 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | Week 6 (n = 6, 8, 8) | -0.8 units on a scale | Standard Error 1.89 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | Week 8 (n = 6, 8, 7) | -3.4 units on a scale | Standard Error 2.54 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | Week 6 (n = 6, 8, 8) | -1.2 units on a scale | Standard Error 1.89 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | Week 7 (n = 6, 8, 7) | -1.9 units on a scale | Standard Error 1.74 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2 | Week 5 (n = 6, 8, 8) | 0.5 units on a scale | Standard Error 1.49 |
Comparison: (PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).p-value: 0.70890% CI: [-3.2, 5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).p-value: 0.64690% CI: [-5.2, 3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).p-value: 0.35290% CI: [-1.6, 5.6]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).p-value: 0.49590% CI: [-3.1, 7.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).p-value: 0.42290% CI: [-2.7, 7.6]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).p-value: 0.88990% CI: [-5, 4.2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).p-value: 0.32490% CI: [-2, 7.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).p-value: 0.93990% CI: [-4.5, 4.9]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).p-value: 0.30890% CI: [-1.7, 6.7]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).p-value: 0.84690% CI: [-6, 7.6]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).p-value: 0.44990% CI: [-9.8, 3.7]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).p-value: 0.29590% CI: [-2.3, 9.9]Mixed-Effects Model Repeated Measure
Secondary
Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2
SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.
Time frame: Stage 1: Week 4, Stage 2: Week 8
Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Stage 1) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Social Sub-scale Score (n= 40,22,20,6,8,7) | -1.8 units on a scale | Standard Error 0.53 |
| Placebo (Stage 1) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Total Score (n= 40,22,20,6,8,7) | -3.5 units on a scale | Standard Error 0.98 |
| Placebo (Stage 1) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Family Sub-scale Score 9 (n= 40, 22, 20,6,8,7) | -0.9 units on a scale | Standard Error 0.36 |
| Placebo (Stage 1) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Work Sub-scale Score (n= 30,16,14,6,5,6) | -0.7 units on a scale | Standard Error 0.41 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Work Sub-scale Score (n= 30,16,14,6,5,6) | -2.4 units on a scale | Standard Error 0.56 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Total Score (n= 40,22,20,6,8,7) | -5.3 units on a scale | Standard Error 1.33 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Social Sub-scale Score (n= 40,22,20,6,8,7) | -1.7 units on a scale | Standard Error 0.5 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Family Sub-scale Score 9 (n= 40, 22, 20,6,8,7) | -1.6 units on a scale | Standard Error 0.48 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Total Score (n= 40,22,20,6,8,7) | -4.7 units on a scale | Standard Error 1.4 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Social Sub-scale Score (n= 40,22,20,6,8,7) | -1.8 units on a scale | Standard Error 0.53 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Work Sub-scale Score (n= 30,16,14,6,5,6) | -1.5 units on a scale | Standard Error 0.6 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Family Sub-scale Score 9 (n= 40, 22, 20,6,8,7) | -1.4 units on a scale | Standard Error 0.51 |
| Placebo (Stage 2) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Social Sub-scale Score (n= 40,22,20,6,8,7) | -0.3 units on a scale | Standard Error 1.32 |
| Placebo (Stage 2) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Work Sub-scale Score (n= 30,16,14,6,5,6) | -0.7 units on a scale | Standard Error 0.96 |
| Placebo (Stage 2) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Family Sub-scale Score 9 (n= 40, 22, 20,6,8,7) | -1.4 units on a scale | Standard Error 0.92 |
| Placebo (Stage 2) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Total Score (n= 40,22,20,6,8,7) | -3.5 units on a scale | Standard Error 2.9 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Work Sub-scale Score (n= 30,16,14,6,5,6) | -2.6 units on a scale | Standard Error 1.01 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Family Sub-scale Score 9 (n= 40, 22, 20,6,8,7) | -1.9 units on a scale | Standard Error 0.78 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Social Sub-scale Score (n= 40,22,20,6,8,7) | -2.3 units on a scale | Standard Error 1.03 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Total Score (n= 40,22,20,6,8,7) | -5.9 units on a scale | Standard Error 2.36 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Work Sub-scale Score (n= 30,16,14,6,5,6) | -1.4 units on a scale | Standard Error 0.93 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Total Score (n= 40,22,20,6,8,7) | -2.4 units on a scale | Standard Error 2.4 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Social Sub-scale Score (n= 40,22,20,6,8,7) | -0.6 units on a scale | Standard Error 1.07 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2 | Family Sub-scale Score 9 (n= 40, 22, 20,6,8,7) | -1.0 units on a scale | Standard Error 0.8 |
Comparison: (PF-06372865 7.5 mg - Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.51490% CI: [-4, 1.7]ANCOVA
Comparison: (PF-06372865 2.5 mg - Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.30290% CI: [-4.5, 1]ANCOVA
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.73690% CI: [-2.6, 3.8]ANCOVA
Comparison: (PF-06372865 7.5 mg - Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.77590% CI: [-5.6, 7.8]ANCOVA
Comparison: (PF-06372865 2.5 mg - Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.55390% CI: [-9.4, 4.5]ANCOVA
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.29990% CI: [-2.2, 9.3]ANCOVA
Comparison: (PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.99490% CI: [-1.1, 1.1]ANCOVA
Comparison: (PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.8790% CI: [-0.9, 1.1]ANCOVA
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.88590% CI: [-1.3, 1.1]ANCOVA
Comparison: (PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.83490% CI: [-3.5, 2.7]ANCOVA
Comparison: (PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.28190% CI: [-5.1, 1.1]ANCOVA
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.27290% CI: [-0.9, 4.1]ANCOVA
Comparison: (PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.24990% CI: [-2.1, 0.4]ANCOVA
Comparison: (PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.01690% CI: [-2.9, -0.6]ANCOVA
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.2850.285% CI: [-0.5, 2.3]ANCOVA
Comparison: (PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.63590% CI: [-3.1, 1.8]ANCOVA
Comparison: (PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.21790% CI: [-4.4, 0.7]ANCOVA
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.39990% CI: [-1.2, 3.6]ANCOVA
Comparison: (PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.42990% CI: [-1.5, 0.5]ANCOVA
Comparison: (PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.2690% CI: [-1.7, 0.3]ANCOVA
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.79990% CI: [-1, 1.3]ANCOVA
Comparison: (PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.73890% CI: [-1.7, 2.5]ANCOVA
Comparison: (PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.69190% CI: [-2.7, 1.7]ANCOVA
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.41790% CI: [-1, 2.9]ANCOVA
Comparison: (PF-06372865 7.5 mg - Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.99890% CI: [-3.7, 3.7]ANCOVA
Comparison: (PF-06372865 2.5 mg - Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.35390% CI: [-5.8, 1.7]ANCOVA
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.29690% CI: [-1.3, 5.4]ANCOVA
Comparison: (PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.84190% CI: [-1.8, 1.5]ANCOVA
Comparison: (PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.33290% CI: [-2.6, 0.7]ANCOVA
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.35990% CI: [-0.6, 2.2]ANCOVA
Comparison: (PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.34790% CI: [-2.1, 0.6]ANCOVA
Comparison: (PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.04190% CI: [-3.2, -0.4]ANCOVA
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.21290% CI: [-0.4, 2.4]ANCOVA
Comparison: (PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.95490% CI: [-1.2, 1.2]ANCOVA
Comparison: (PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.40790% CI: [-1.8, 0.6]ANCOVA
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.p-value: 0.41290% CI: [-0.6, 1.7]ANCOVA
Secondary
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Psychic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.
Time frame: Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)
Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -3.8 units on a scale | Standard Deviation 3.92 |
| Placebo (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8) | -2.8 units on a scale | Standard Deviation 3.87 |
| Placebo (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -5.3 units on a scale | Standard Deviation 4.21 |
| Placebo (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 16.5 units on a scale | Standard Deviation 2.23 |
| Placebo (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -5.9 units on a scale | Standard Deviation 4.63 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8) | -2.7 units on a scale | Standard Deviation 3.42 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -4.4 units on a scale | Standard Deviation 4.53 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -3.4 units on a scale | Standard Deviation 4.97 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 15.2 units on a scale | Standard Deviation 2.36 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -4.0 units on a scale | Standard Deviation 5.19 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -5.4 units on a scale | Standard Deviation 3.63 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 16.1 units on a scale | Standard Deviation 1.77 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8) | -3.2 units on a scale | Standard Deviation 2.87 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -5.8 units on a scale | Standard Deviation 3.89 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -4.6 units on a scale | Standard Deviation 4.35 |
| Placebo (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -0.8 units on a scale | Standard Deviation 2.86 |
| Placebo (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -2.5 units on a scale | Standard Deviation 3.56 |
| Placebo (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8) | -0.3 units on a scale | Standard Deviation 2.88 |
| Placebo (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -1.7 units on a scale | Standard Deviation 2.42 |
| Placebo (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 15.5 units on a scale | Standard Deviation 2.88 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -2.3 units on a scale | Standard Deviation 3.28 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 13.0 units on a scale | Standard Deviation 4.54 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8) | -0.6 units on a scale | Standard Deviation 2.83 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -3.9 units on a scale | Standard Deviation 3.27 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | 0.4 units on a scale | Standard Deviation 2.97 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -1.6 units on a scale | Standard Deviation 3.05 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 12.9 units on a scale | Standard Deviation 3.87 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8) | 0.3 units on a scale | Standard Deviation 1.28 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -0.7 units on a scale | Standard Deviation 1.8 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -0.6 units on a scale | Standard Deviation 2.2 |
Comparison: (PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.56290% CI: [-2.1, 1]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.70890% CI: [-1.9, 1.2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.85290% CI: [-1.9, 1.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.34790% CI: [-3, 0.8]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.75990% CI: [-2.2, 1.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.57490% CI: [-2.9, 1.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.83190% CI: [-2.1, 1.6]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.70590% CI: [-1.4, 2.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.690% CI: [-2.7, 1.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.84890% CI: [-2.3, 1.8]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.23790% CI: [-0.6, 3.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.22490% CI: [-4, 0.6]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.74790% CI: [-1.9, 2.8]LS Mean Difference
Comparison: (PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28). Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.76490% CI: [-2.8, 2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.48790% CI: [-1.3, 3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.74490% CI: [-2.1, 3.2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.3490% CI: [-1.1, 4.1]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.47790% CI: [-3.3, 1.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.48290% CI: [-1.5, 3.7]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.71990% CI: [-3.1, 2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.24590% CI: [-0.7, 4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.58690% CI: [-2.3, 4.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.4490% CI: [-4.8, 1.8]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.15990% CI: [-0.5, 5.6]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.p-value: 0.7290% CI: [-1.6, 2.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.p-value: 0.99190% CI: [-2, 1.9]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.p-value: 0.70490% CI: [-1.5, 2.4]Mixed-Effects Model Repeated Measure
Secondary
Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8
The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Somatic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.
Time frame: Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)
Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -4.9 units on a scale | Standard Deviation 3.63 |
| Placebo (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -3.2 units on a scale | Standard Deviation 3.09 |
| Placebo (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 11.5 units on a scale | Standard Deviation 3.76 |
| Placebo (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -4.8 units on a scale | Standard Deviation 4.62 |
| Placebo (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8) | -3.2 units on a scale | Standard Deviation 3.37 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -4.1 units on a scale | Standard Deviation 3.19 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -3.7 units on a scale | Standard Deviation 3.27 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -2.8 units on a scale | Standard Deviation 2.24 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8) | -2.6 units on a scale | Standard Deviation 2.9 |
| PF-06372865 2.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 11.5 units on a scale | Standard Deviation 3.15 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -3.8 units on a scale | Standard Deviation 3.49 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 10.0 units on a scale | Standard Deviation 4.01 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -3.6 units on a scale | Standard Deviation 3.47 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8) | -2.4 units on a scale | Standard Deviation 2.77 |
| PF-06372865 7.5 mg (Stage 1) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -2.9 units on a scale | Standard Deviation 4.27 |
| Placebo (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -2.0 units on a scale | Standard Deviation 5.62 |
| Placebo (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8) | -0.3 units on a scale | Standard Deviation 3.78 |
| Placebo (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -2.7 units on a scale | Standard Deviation 4.68 |
| Placebo (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -2.8 units on a scale | Standard Deviation 3.66 |
| Placebo (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 10.7 units on a scale | Standard Deviation 5.2 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -2.3 units on a scale | Standard Deviation 2.82 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 9.5 units on a scale | Standard Deviation 2.98 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -1.1 units on a scale | Standard Deviation 2.03 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8) | -0.8 units on a scale | Standard Deviation 2.6 |
| PF-06372865 2.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -3.1 units on a scale | Standard Deviation 3.14 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W3, S2: W7 (n=39,22,21,6,8,7) | -1.3 units on a scale | Standard Deviation 3.5 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W4, S2: W8 (n=40,22,20,6,8,7) | -2.0 units on a scale | Standard Deviation 4.08 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W2, S2: W6 (n=39,23,21,6,8,8) | -0.5 units on a scale | Standard Deviation 3.51 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Baseline: S1 and S2 (n=45,24,21,6,8,8) | 9.6 units on a scale | Standard Deviation 3.34 |
| PF-06372865 7.5 mg (Stage 2) | Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8 | Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8) | 0.4 units on a scale | Standard Deviation 2.07 |
Comparison: (PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.53990% CI: [-0.9, 1.9]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.43990% CI: [-0.7, 1.9]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.91490% CI: [-1.6, 1.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.89290% CI: [-1.3, 1.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.46390% CI: [-0.8, 2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.61190% CI: [-2.1, 1.1]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.32190% CI: [-0.6, 2.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.29490% CI: [-0.5, 2.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.98790% CI: [-1.7, 1.6]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.59990% CI: [-1.2, 2.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.32290% CI: [-0.7, 2.6]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.70490% CI: [-2.4, 1.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.80490% CI: [-2, 2.7]LS Mean Difference
Comparison: (PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.55990% CI: [-3.2, 1.6]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.36990% CI: [-1, 3.4]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.31390% CI: [-1.1, 4.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.5690% CI: [-1.8, 3.6]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.63590% CI: [-1.8, 3.2]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.53890% CI: [-1.8, 3.8]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.94290% CI: [-2.7, 2.9]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.55590% CI: [-1.7, 3.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.72890% CI: [-4.1, 2.7]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.36290% CI: [-5.2, 1.6]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).p-value: 0.53890% CI: [-2, 4.3]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.p-value: 0.94990% CI: [-2, 1.8]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 2.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.p-value: 0.70890% CI: [-2.3, 1.5]Mixed-Effects Model Repeated Measure
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.p-value: 0.75290% CI: [-1.5, 2.2]Mixed-Effects Model Repeated Measure
Secondary
Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores
Percentage of participants with HAM-A total score less than or equal to 7 in the last week of the Stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
Time frame: Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8
Population: Full analysis set for Stage 1 was defined as all participants randomized and who had received at least 1 dose of randomized treatment. The Stage 2 placebo non-responder set was defined as the subset of subjects in the Stage 2 placebo set who had both a \<50% reduction in HAM-A between Stage 1 baseline and Week 4, and HAM-A value of \>= 16 at Week 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Stage 1) | Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores | 6.67 percentage of participants |
| PF-06372865 2.5 mg (Stage 1) | Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores | 12.50 percentage of participants |
| PF-06372865 7.5 mg (Stage 1) | Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores | 4.76 percentage of participants |
| Placebo (Stage 2) | Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores | 0 percentage of participants |
| PF-06372865 2.5 mg (Stage 2) | Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores | 0 percentage of participants |
| PF-06372865 7.5 mg (Stage 2) | Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores | 12.50 percentage of participants |
Comparison: (PF-06372865 7.5 mg - Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).90% CI: [0.37, 2.45]Regression, Logistic
Comparison: (PF-06372865 2.5 mg - Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).90% CI: [0.39, 6.88]Regression, Logistic
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).90% CI: [0.23, 1.49]Regression, Logistic
Secondary
Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2
A responder was defined as a participant with \>= to 50 percent decrease in their total HAM-A score from baseline to the last week in the stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. Percentage of responders of total HMA scale were reported.
Time frame: Stage 1: Week 4, Stage 2: Week 8
Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Stage 1) | Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2 | 33.33 percentage of participants |
| PF-06372865 2.5 mg (Stage 1) | Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2 | 25.00 percentage of participants |
| PF-06372865 7.5 mg (Stage 1) | Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2 | 28.57 percentage of participants |
| Placebo (Stage 2) | Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2 | 16.67 percentage of participants |
| PF-06372865 2.5 mg (Stage 2) | Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2 | 25.00 percentage of participants |
| PF-06372865 7.5 mg (Stage 2) | Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2 | 12.50 percentage of participants |
Comparison: (PF-06372865 7.5 mg - Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.90% CI: [0.45, 1.26]Regression, Logistic
Comparison: (PF-06372865 2.5 mg - Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.90% CI: [0.23, 1.54]Regression, Logistic
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.90% CI: [0.69, 2.32]Regression, Logistic
Comparison: (PF-06372865 7.5 mg - Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.90% CI: [0.27, 5.78]Regression, Logistic
Comparison: (PF-06372865 2.5 mg - Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.90% CI: [0.19, 24.51]Regression, Logistic
Comparison: (PF-06372865 7.5 mg - PF-06372865 2.5 mg). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.90% CI: [0.16, 2.09]Regression, Logistic
Secondary
Plasma Concentration Versus Time Summary of PF-06372865: Stage 1
Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 nanogram per milliliter (ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.
Time frame: Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 2, 3, 4
Population: Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 2 : 0 Hour (n= 12, 10) | 10.89 ng/mL | Standard Deviation 7.1367 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 2 : 2 Hour (n= 13, 10) | 20.76 ng/mL | Standard Deviation 10.06 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 2 : 4 Hour (n= 5, 8) | 16.07 ng/mL | Standard Deviation 18.541 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 2 : 10 Hour (n= 5, 9) | 17.41 ng/mL | Standard Deviation 14.951 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 4 : 2 Hour (n= 8, 10) | 26.32 ng/mL | Standard Deviation 20.328 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 4 : 4 Hour (n= 11, 5) | 29.58 ng/mL | Standard Deviation 12.398 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 4 : 10 Hour (n= 10, 5) | 28.48 ng/mL | Standard Deviation 11.55 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 3 : 0 Hour (n= 6, 5) | 11.62 ng/mL | Standard Deviation 10.44 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 3 : 2 Hour (n= 6, 4) | 16.42 ng/mL | Standard Deviation 13.626 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 3 : 4 Hour (n= 10, 9) | 22.20 ng/mL | Standard Deviation 19.11 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 3 : 10 Hour (n= 10, 9) | 19.40 ng/mL | Standard Deviation 13.88 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 4 : 0 Hour (n= 7, 9) | 14.36 ng/mL | Standard Deviation 18.77 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 4 : 4 Hour (n= 11, 5) | 79.00 ng/mL | Standard Deviation 69.914 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 2 : 0 Hour (n= 12, 10) | 64.73 ng/mL | Standard Deviation 58.463 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 3 : 2 Hour (n= 6, 4) | 54.02 ng/mL | Standard Deviation 54.091 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 2 : 2 Hour (n= 13, 10) | 113.8 ng/mL | Standard Deviation 55.517 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 4 : 10 Hour (n= 10, 5) | 78.60 ng/mL | Standard Deviation 81.529 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 2 : 4 Hour (n= 5, 8) | 77.75 ng/mL | Standard Deviation 65.594 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 3 : 10 Hour (n= 10, 9) | 73.31 ng/mL | Standard Deviation 57.082 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 2 : 10 Hour (n= 5, 9) | 66.60 ng/mL | Standard Deviation 53.888 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 4 : 0 Hour (n= 7, 9) | 27.15 ng/mL | Standard Deviation 20.84 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 3 : 0 Hour (n= 6, 5) | 33.44 ng/mL | Standard Deviation 34.409 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 4 : 2 Hour (n= 8, 10) | 61.98 ng/mL | Standard Deviation 21.457 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 1 | Week 3 : 4 Hour (n= 10, 9) | 81.58 ng/mL | Standard Deviation 54.133 |
Secondary
Plasma Concentration Versus Time Summary of PF-06372865: Stage 2
Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.
Time frame: Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 6, 7, 8
Population: Placebo Non-Responder set for Stage 2. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 6 : 0 Hour (n= 3, 2) | 23.12 ng/mL | Standard Deviation 22.644 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 6 : 2 Hour (n= 5, 3) | 24.62 ng/mL | Standard Deviation 16.959 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 7 : 10 Hour (n= 3, 4) | 33.54 ng/mL | Standard Deviation 38.779 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 8 : 0 Hour (n= 3, 5) | 25.18 ng/mL | Standard Deviation 17.783 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 8 : 2 Hour (n= 4, 6) | 34.55 ng/mL | Standard Deviation 14.856 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 8 : 4 Hour (n= 4, 3) | 13.54 ng/mL | Standard Deviation 15.435 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 8 : 10 Hour (n= 3, 2) | 14.00 ng/mL | Standard Deviation 15.88 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 6 : 4 Hour (n= 2, 3) | 16.83 ng/mL | Standard Deviation 19.459 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 6 : 10 Hour (n= 2, 3) | 14.00 ng/mL | Standard Deviation 16.191 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 7 : 0 Hour (n= 3, 3) | 25.88 ng/mL | Standard Deviation 20.591 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 7 : 2 Hour (n= 4, 2) | 24.54 ng/mL | Standard Deviation 17.913 |
| Placebo (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 7 : 4 Hour (n= 3, 4) | 34.80 ng/mL | Standard Deviation 44.089 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 7 : 2 Hour (n= 4, 2) | 16.40 ng/mL | Standard Deviation 14.262 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 6 : 0 Hour (n= 3, 2) | 35.67 ng/mL | Standard Deviation 31.015 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 8 : 10 Hour (n= 3, 2) | 14.00 ng/mL | Standard Deviation 15.88 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 6 : 2 Hour (n= 5, 3) | 59.40 ng/mL | Standard Deviation 46.218 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 7 : 4 Hour (n= 3, 4) | 57.28 ng/mL | Standard Deviation 38.837 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 7 : 0 Hour (n= 3, 3) | 17.54 ng/mL | Standard Deviation 9.718 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 7 : 10 Hour (n= 3, 4) | 64.45 ng/mL | Standard Deviation 22.42 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 6 : 4 Hour (n= 2, 3) | 75.98 ng/mL | Standard Deviation 60.38 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 8 : 0 Hour (n= 3, 5) | 32.73 ng/mL | Standard Deviation 25.175 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 8 : 2 Hour (n= 4, 6) | 48.83 ng/mL | Standard Deviation 39.032 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 6 : 10 Hour (n= 2, 3) | 66.43 ng/mL | Standard Deviation 52.402 |
| PF-06372865 2.5 mg (Stage 1) | Plasma Concentration Versus Time Summary of PF-06372865: Stage 2 | Week 8 : 4 Hour (n= 4, 3) | 13.54 ng/mL | Standard Deviation 15.435 |
Secondary
Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2
SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.
Time frame: Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)
Population: Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Stage 1) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Family Subscale Score (n= 45,24,21,6,8,8) | 6.2 units on a scale | Standard Deviation 2.1 |
| Placebo (Stage 1) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Work Subscale Score (n =37,19,16,6,6,7) | 5.9 units on a scale | Standard Deviation 2.59 |
| Placebo (Stage 1) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Total Score (n=45,24,21,6,8,8) | 18.6 units on a scale | Standard Deviation 5.8 |
| Placebo (Stage 1) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Social Subscale Score (n=45,24,21,6,8,8) | 6.6 units on a scale | Standard Deviation 1.96 |
| PF-06372865 2.5 mg (Stage 1) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Work Subscale Score (n =37,19,16,6,6,7) | 5.8 units on a scale | Standard Deviation 3.06 |
| PF-06372865 2.5 mg (Stage 1) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Social Subscale Score (n=45,24,21,6,8,8) | 7.2 units on a scale | Standard Deviation 1.88 |
| PF-06372865 2.5 mg (Stage 1) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Total Score (n=45,24,21,6,8,8) | 19.6 units on a scale | Standard Deviation 5.73 |
| PF-06372865 2.5 mg (Stage 1) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Family Subscale Score (n= 45,24,21,6,8,8) | 6.2 units on a scale | Standard Deviation 2.17 |
| PF-06372865 7.5 mg (Stage 1) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Total Score (n=45,24,21,6,8,8) | 17.0 units on a scale | Standard Deviation 5.55 |
| PF-06372865 7.5 mg (Stage 1) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Social Subscale Score (n=45,24,21,6,8,8) | 5.9 units on a scale | Standard Deviation 1.8 |
| PF-06372865 7.5 mg (Stage 1) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Work Subscale Score (n =37,19,16,6,6,7) | 5.9 units on a scale | Standard Deviation 2.28 |
| PF-06372865 7.5 mg (Stage 1) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Family Subscale Score (n= 45,24,21,6,8,8) | 5.5 units on a scale | Standard Deviation 2.23 |
| Placebo (Stage 2) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Social Subscale Score (n=45,24,21,6,8,8) | 7.8 units on a scale | Standard Deviation 1.17 |
| Placebo (Stage 2) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Family Subscale Score (n= 45,24,21,6,8,8) | 7.7 units on a scale | Standard Deviation 1.03 |
| Placebo (Stage 2) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Work Subscale Score (n =37,19,16,6,6,7) | 7.5 units on a scale | Standard Deviation 1.38 |
| Placebo (Stage 2) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Total Score (n=45,24,21,6,8,8) | 23.0 units on a scale | Standard Deviation 2.76 |
| PF-06372865 2.5 mg (Stage 2) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Social Subscale Score (n=45,24,21,6,8,8) | 5.0 units on a scale | Standard Deviation 2.56 |
| PF-06372865 2.5 mg (Stage 2) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Work Subscale Score (n =37,19,16,6,6,7) | 5.3 units on a scale | Standard Deviation 2.58 |
| PF-06372865 2.5 mg (Stage 2) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Family Subscale Score (n= 45,24,21,6,8,8) | 5.3 units on a scale | Standard Deviation 2.49 |
| PF-06372865 2.5 mg (Stage 2) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Total Score (n=45,24,21,6,8,8) | 15.3 units on a scale | Standard Deviation 6.86 |
| PF-06372865 7.5 mg (Stage 2) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Social Subscale Score (n=45,24,21,6,8,8) | 5.5 units on a scale | Standard Deviation 1.2 |
| PF-06372865 7.5 mg (Stage 2) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Work Subscale Score (n =37,19,16,6,6,7) | 5.6 units on a scale | Standard Deviation 2.44 |
| PF-06372865 7.5 mg (Stage 2) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Family Subscale Score (n= 45,24,21,6,8,8) | 6.3 units on a scale | Standard Deviation 2.6 |
| PF-06372865 7.5 mg (Stage 2) | Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2 | Total Score (n=45,24,21,6,8,8) | 17.4 units on a scale | Standard Deviation 4.89 |