Postpartum Depression
Conditions
Keywords
Moderate Postpartum Depression, SAGE-547
Brief summary
The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.
Interventions
DRUGPlacebo
Intravenous infusion of matching placebo for SAGE-547.
Intravenous infusion of SAGE-547
Sponsors
Supernus Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participant either must have ceased lactating at screening; or if still lactating or actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to their infant(s). * Participant had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I). * Participant had a HAM-D total score of ≥20 and ≤25 at screening and Day 1 (prior to dosing). * Participant was ≤ six months postpartum. * Participant was amenable to intravenous therapy. Key
Exclusion criteria
* Active psychosis. * Attempted suicide associated with index case of postpartum depression. * Medical history of bipolar disorder. Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at 60 Hours in 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score | Baseline, Hour 60 | The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HAM-D Total Score | Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14 and 21 | The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression. |
| Percentage of Participants With HAM-D Response | Hour 60, Days 7 and 30 | The HAM-D response is defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression. |
| Percentage of Participants With HAM-D Remission | Hour 60, Days 7 and 30 | HAM-D remission is defined as having a HAM-D total score of ≤7. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression. |
| Change From Baseline in HAM-D Bech 6 Subscale | Baseline, Hour 60, Days 7 and 30 | The HAM-D Bech 6 subscale score is calculated as the sum of the following six items: Item # 1 (depressed mood), Item # 2 (feelings of guilt), Item # 7 (work and activities), Item # 8 (retardation), Item # 10 (anxiety psychic), and Item # 13 (general somatic symptoms). Each item is scored in a range of 0 to 2 or 0 to 4, with higher scores indicating a greater degree of depression. The scores were transformed to a 100-point scale with a higher score indicating a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression. |
| Change From Baseline in HAM-D Individual Item Scores | Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 60, 72, and Days 7, 14, 21, and 30 | The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression. |
| Change From Baseline in HAM-D Total Score at Day 30 | Baseline, Day 30 | The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression. |
| Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Hour 60, Days 7 and 30 | The CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. |
| Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score | Baseline, Hour 60, Days 7, 14, 21 and 30 | The GAD-7 is a participant-rated, generalized anxiety symptom severity scale. Scoring for GAD-7 generalized anxiety is calculated by assigning scores of 0 = not at all sure, 1 = several days, 2 = over half the days, and 3 = nearly every day to the response categories. The GAD-7 total score for the seven items ranges from 0 to 21, where a score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and 15 to 21 = severe anxiety. The GAD-7 total score was calculated as the sum of the seven individual item scores. A negative change from baseline indicates less anxiety. A positive change from baseline indicates more anxiety. |
| Percentage of Participants With Treatment Emergent Adverse Event (TEAE) | Up to approximately 37 days | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion. |
| Time to Change in Antidepressant Medication | Up to approximately 37 days | The time to first start or increase in the dose and time to first stop or decrease in the dose of any antidepressant medication. |
| Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Baseline, Hour 60, Days 7 and 30 | The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicates more severe depression. A negative change from baseline indicates less severe depression. A positive change from baseline indicates more severe depression. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 32 centers in United States from 25 July 2016 to 11 October 2017.
Pre-assignment details
A total of 108 participants were randomized into the study to receive either placebo or SAGE-547, 104 of whom received the study drug.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received an infusion rate equivalent to the 90 μg/kg/h group. | 53 |
| SAGE-547 90 μg/kg/h Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours). | 51 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Randomized but not dosed | 1 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | SAGE-547 90 μg/kg/h | Total |
|---|---|---|---|
| Age, Continuous | 27.3 years STANDARD_DEVIATION 5.9 | 28.2 years STANDARD_DEVIATION 6.09 | 27.8 years STANDARD_DEVIATION 5.98 |
| Hamilton Rating Scale for Depression (HAMD) Total Score | 22.7 score on a scale STANDARD_DEVIATION 1.59 | 22.6 score on a scale STANDARD_DEVIATION 1.56 | 22.7 score on a scale STANDARD_DEVIATION 1.57 |
| Race/Ethnicity, Customized Black or African American | 19 Participants | 22 Participants | 41 Participants |
| Race/Ethnicity, Customized Hispanic or Latina | 14 Participants | 10 Participants | 24 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latina | 39 Participants | 41 Participants | 80 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 33 Participants | 29 Participants | 62 Participants |
| Sex: Female, Male Female | 53 Participants | 51 Participants | 104 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 51 |
| other Total, other adverse events | 13 / 53 | 21 / 51 |
| serious Total, serious adverse events | 0 / 53 | 1 / 51 |
Outcome results
Primary
Change From Baseline at 60 Hours in 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score
The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Time frame: Baseline, Hour 60
Population: All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline at 60 Hours in 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score | -12.12 score on a scale | Standard Error 0.773 |
| SAGE-547 90 μg/kg/h | Change From Baseline at 60 Hours in 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score | -14.62 score on a scale | Standard Error 0.782 |
Comparison: Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.01695% CI: [-4.52, -0.48]MMRM
Secondary
Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicates more severe depression. A negative change from baseline indicates less severe depression. A positive change from baseline indicates more severe depression.
Time frame: Baseline, Hour 60, Days 7 and 30
Population: All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Hour 60 | -15.66 score on a scale | Standard Deviation 1.329 |
| Placebo | Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Day 7 | -15.35 score on a scale | Standard Deviation 1.658 |
| Placebo | Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Day 30 | -20.52 score on a scale | Standard Deviation 1.489 |
| SAGE-547 90 μg/kg/h | Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Hour 60 | -20.52 score on a scale | Standard Deviation 1.333 |
| SAGE-547 90 μg/kg/h | Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Day 7 | -18.91 score on a scale | Standard Deviation 1.676 |
| SAGE-547 90 μg/kg/h | Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Day 30 | -20.48 score on a scale | Standard Deviation 1.504 |
Comparison: Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.003395% CI: [-8.06, -1.66]MMRM
Comparison: Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.101795% CI: [-7.84, 0.72]MMRM
Comparison: Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.984595% CI: [-3.72, 3.79]MMRM
Secondary
Change From Baseline in HAM-D Bech 6 Subscale
The HAM-D Bech 6 subscale score is calculated as the sum of the following six items: Item # 1 (depressed mood), Item # 2 (feelings of guilt), Item # 7 (work and activities), Item # 8 (retardation), Item # 10 (anxiety psychic), and Item # 13 (general somatic symptoms). Each item is scored in a range of 0 to 2 or 0 to 4, with higher scores indicating a greater degree of depression. The scores were transformed to a 100-point scale with a higher score indicating a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Time frame: Baseline, Hour 60, Days 7 and 30
Population: All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in HAM-D Bech 6 Subscale | Change at Hour 60 | -29.23 score on a scale | Standard Error 2.248 |
| Placebo | Change From Baseline in HAM-D Bech 6 Subscale | Change at Day 7 | -25.05 score on a scale | Standard Error 2.624 |
| Placebo | Change From Baseline in HAM-D Bech 6 Subscale | Change at Day 30 | -36.24 score on a scale | Standard Error 2.345 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Bech 6 Subscale | Change at Hour 60 | -37.59 score on a scale | Standard Error 2.276 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Bech 6 Subscale | Change at Day 7 | -34.80 score on a scale | Standard Error 2.668 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Bech 6 Subscale | Change at Day 30 | -34.86 score on a scale | Standard Error 2.39 |
Comparison: Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.006395% CI: [-14.29, -2.42]MMRM
Comparison: Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.007495% CI: [-16.83, -2.68]MMRM
Comparison: Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.663795% CI: [-4.88, 7.63]MMRM
Secondary
Change From Baseline in HAM-D Individual Item Scores
The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Time frame: Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 60, 72, and Days 7, 14, 21, and 30
Population: All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 2 | -0.35 score on a scale | Standard Error 0.121 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 4 | -0.67 score on a scale | Standard Error 0.137 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 8 | -0.90 score on a scale | Standard Error 0.136 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 12 | -1.05 score on a scale | Standard Error 0.139 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 24 | -1.01 score on a scale | Standard Error 0.143 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 36 | -1.35 score on a scale | Standard Error 0.145 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 48 | -1.33 score on a scale | Standard Error 0.144 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 60 | -1.62 score on a scale | Standard Error 0.142 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 72 | -1.63 score on a scale | Standard Error 0.137 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Day 7 | -1.43 score on a scale | Standard Error 0.159 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Day 14 | -1.42 score on a scale | Standard Error 0.17 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Day 21 | -1.80 score on a scale | Standard Error 0.168 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Day 30 | -2.07 score on a scale | Standard Error 0.137 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 2 | -0.37 score on a scale | Standard Error 0.125 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 4 | -0.56 score on a scale | Standard Error 0.127 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 8 | -0.81 score on a scale | Standard Error 0.124 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 12 | -0.69 score on a scale | Standard Error 0.127 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 24 | -0.86 score on a scale | Standard Error 0.122 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 36 | -0.75 score on a scale | Standard Error 0.127 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 48 | -0.90 score on a scale | Standard Error 0.129 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 60 | -0.99 score on a scale | Standard Error 0.119 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 72 | -0.94 score on a scale | Standard Error 0.121 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Day 7 | -0.82 score on a scale | Standard Error 0.135 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Day 14 | -0.90 score on a scale | Standard Error 0.133 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Day 21 | -1.01 score on a scale | Standard Error 0.126 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Day 30 | -1.31 score on a scale | Standard Error 0.111 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 2 | -0.11 score on a scale | Standard Error 0.062 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 4 | -0.20 score on a scale | Standard Error 0.062 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 8 | -0.26 score on a scale | Standard Error 0.062 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 12 | -0.27 score on a scale | Standard Error 0.062 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 24 | -0.31 score on a scale | Standard Error 0.062 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 36 | -0.29 score on a scale | Standard Error 0.062 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 48 | -0.29 score on a scale | Standard Error 0.062 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 60 | -0.33 score on a scale | Standard Error 0.062 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 72 | -0.33 score on a scale | Standard Error 0.062 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Day 7 | -0.29 score on a scale | Standard Error 0.062 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Day 14 | -0.35 score on a scale | Standard Error 0.068 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Day 21 | -0.36 score on a scale | Standard Error 0.068 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Day 30 | -0.37 score on a scale | Standard Error 0.062 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 2 | -0.18 score on a scale | Standard Error 0.077 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 4 | -0.35 score on a scale | Standard Error 0.092 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 8 | -0.28 score on a scale | Standard Error 0.085 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 12 | -0.36 score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 24 | -0.54 score on a scale | Standard Error 0.111 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 36 | -0.62 score on a scale | Standard Error 0.115 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 48 | -0.62 score on a scale | Standard Error 0.122 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 60 | -0.87 score on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 72 | -0.54 score on a scale | Standard Error 0.119 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Day 7 | -0.69 score on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Day 14 | -0.78 score on a scale | Standard Error 0.142 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Day 21 | -0.98 score on a scale | Standard Error 0.156 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Day 30 | -1.05 score on a scale | Standard Error 0.126 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 2 | -0.18 score on a scale | Standard Error 0.089 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 4 | -0.20 score on a scale | Standard Error 0.092 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 8 | -0.28 score on a scale | Standard Error 0.092 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 12 | -0.30 score on a scale | Standard Error 0.094 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 24 | -0.52 score on a scale | Standard Error 0.103 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 36 | -0.64 score on a scale | Standard Error 0.103 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 48 | -0.58 score on a scale | Standard Error 0.106 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 60 | -0.67 score on a scale | Standard Error 0.099 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 72 | -0.77 score on a scale | Standard Error 0.101 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Day 7 | -0.67 score on a scale | Standard Error 0.112 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Day 14 | -0.62 score on a scale | Standard Error 0.135 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Day 21 | -0.81 score on a scale | Standard Error 0.139 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Day 30 | -0.84 score on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Day 7 | -0.33 score on a scale | Standard Error 0.073 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 2 | -0.14 score on a scale | Standard Error 0.091 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 4 | -0.20 score on a scale | Standard Error 0.095 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 8 | -0.20 score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 12 | -0.21 score on a scale | Standard Error 0.091 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 24 | -0.54 score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 36 | -0.46 score on a scale | Standard Error 0.102 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 48 | -0.56 score on a scale | Standard Error 0.097 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 60 | -0.60 score on a scale | Standard Error 0.098 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 72 | -0.50 score on a scale | Standard Error 0.104 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Day 7 | -0.46 score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Day 14 | -0.27 score on a scale | Standard Error 0.128 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Day 21 | -0.51 score on a scale | Standard Error 0.125 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Day 30 | -0.67 score on a scale | Standard Error 0.099 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 2 | -0.26 score on a scale | Standard Error 0.109 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 4 | -0.73 score on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 8 | -0.77 score on a scale | Standard Error 0.139 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 12 | -1.07 score on a scale | Standard Error 0.151 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 24 | -1.34 score on a scale | Standard Error 0.149 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 36 | -1.54 score on a scale | Standard Error 0.146 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 48 | -1.45 score on a scale | Standard Error 0.138 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 60 | -1.60 score on a scale | Standard Error 0.134 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 72 | -1.68 score on a scale | Standard Error 0.143 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Day 7 | -1.66 score on a scale | Standard Error 0.157 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Day 14 | -1.40 score on a scale | Standard Error 0.161 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Day 21 | -1.75 score on a scale | Standard Error 0.174 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Day 30 | -2.04 score on a scale | Standard Error 0.142 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 2 | -0.03 score on a scale | Standard Error 0.088 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 4 | -0.20 score on a scale | Standard Error 0.085 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 8 | -0.25 score on a scale | Standard Error 0.085 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 12 | -0.27 score on a scale | Standard Error 0.082 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 24 | -0.18 score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 36 | -0.35 score on a scale | Standard Error 0.082 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 48 | -0.35 score on a scale | Standard Error 0.079 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 60 | -0.46 score on a scale | Standard Error 0.066 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 72 | -0.48 score on a scale | Standard Error 0.073 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Day 14 | -0.47 score on a scale | Standard Error 0.061 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Day 21 | -0.51 score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Day 30 | -0.54 score on a scale | Standard Error 0.056 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 2 | -0.27 score on a scale | Standard Error 0.078 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 4 | -0.42 score on a scale | Standard Error 0.082 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 8 | -0.40 score on a scale | Standard Error 0.081 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 12 | -0.32 score on a scale | Standard Error 0.093 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 24 | -0.52 score on a scale | Standard Error 0.081 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 36 | -0.40 score on a scale | Standard Error 0.092 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 48 | -0.44 score on a scale | Standard Error 0.087 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 60 | -0.42 score on a scale | Standard Error 0.097 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 72 | -0.37 score on a scale | Standard Error 0.092 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Day 7 | -0.39 score on a scale | Standard Error 0.096 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Day 14 | -0.58 score on a scale | Standard Error 0.107 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Day 21 | -0.56 score on a scale | Standard Error 0.112 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Day 30 | -0.60 score on a scale | Standard Error 0.075 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 2 | -0.45 score on a scale | Standard Error 0.126 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 4 | -0.81 score on a scale | Standard Error 0.138 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 8 | -0.89 score on a scale | Standard Error 0.141 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 12 | -0.89 score on a scale | Standard Error 0.143 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 24 | -1.00 score on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 36 | -1.06 score on a scale | Standard Error 0.141 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 48 | -0.92 score on a scale | Standard Error 0.142 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 60 | -0.98 score on a scale | Standard Error 0.131 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 72 | -1.08 score on a scale | Standard Error 0.135 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Day 7 | -0.70 score on a scale | Standard Error 0.133 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Day 14 | -0.76 score on a scale | Standard Error 0.178 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Day 21 | -0.94 score on a scale | Standard Error 0.156 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Day 30 | -1.25 score on a scale | Standard Error 0.138 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 2 | -0.54 score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 4 | -0.71 score on a scale | Standard Error 0.098 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 8 | -0.62 score on a scale | Standard Error 0.102 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 12 | -0.60 score on a scale | Standard Error 0.099 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 24 | -0.73 score on a scale | Standard Error 0.103 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 36 | -0.75 score on a scale | Standard Error 0.098 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 48 | -0.79 score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 60 | -0.88 score on a scale | Standard Error 0.101 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 72 | -0.84 score on a scale | Standard Error 0.088 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Day 7 | -0.66 score on a scale | Standard Error 0.112 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Day 14 | -0.85 score on a scale | Standard Error 0.139 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Day 21 | -0.90 score on a scale | Standard Error 0.119 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Day 30 | -0.88 score on a scale | Standard Error 0.11 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 2 | -0.22 score on a scale | Standard Error 0.091 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 4 | -0.33 score on a scale | Standard Error 0.096 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 8 | -0.56 score on a scale | Standard Error 0.087 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 12 | -0.56 score on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 24 | -0.48 score on a scale | Standard Error 0.083 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 36 | -0.60 score on a scale | Standard Error 0.084 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 48 | -0.56 score on a scale | Standard Error 0.086 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 60 | -0.73 score on a scale | Standard Error 0.091 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 72 | -0.77 score on a scale | Standard Error 0.081 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Day 7 | -0.47 score on a scale | Standard Error 0.093 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Day 14 | -0.64 score on a scale | Standard Error 0.093 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Day 21 | -0.61 score on a scale | Standard Error 0.107 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Day 30 | -0.77 score on a scale | Standard Error 0.085 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 2 | -0.18 score on a scale | Standard Error 0.081 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 4 | -0.29 score on a scale | Standard Error 0.095 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 8 | -0.38 score on a scale | Standard Error 0.094 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 12 | -0.50 score on a scale | Standard Error 0.094 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 24 | -0.65 score on a scale | Standard Error 0.104 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 36 | -0.55 score on a scale | Standard Error 0.097 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 48 | -0.61 score on a scale | Standard Error 0.101 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 60 | -0.79 score on a scale | Standard Error 0.105 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 72 | -0.80 score on a scale | Standard Error 0.112 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Day 7 | -0.57 score on a scale | Standard Error 0.102 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Day 14 | -0.66 score on a scale | Standard Error 0.118 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Day 21 | -0.82 score on a scale | Standard Error 0.124 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Day 30 | -0.77 score on a scale | Standard Error 0.104 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 2 | -0.05 score on a scale | Standard Error 0.052 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 4 | -0.09 score on a scale | Standard Error 0.065 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 8 | -0.07 score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 12 | -0.05 score on a scale | Standard Error 0.083 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 24 | -0.11 score on a scale | Standard Error 0.089 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 36 | -0.18 score on a scale | Standard Error 0.091 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 48 | -0.18 score on a scale | Standard Error 0.092 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 60 | -0.23 score on a scale | Standard Error 0.084 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 72 | -0.22 score on a scale | Standard Error 0.102 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Day 7 | -0.52 score on a scale | Standard Error 0.112 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Day 14 | -0.56 score on a scale | Standard Error 0.149 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Day 21 | -0.67 score on a scale | Standard Error 0.147 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Day 30 | -0.84 score on a scale | Standard Error 0.131 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 2 | -0.14 score on a scale | Standard Error 0.077 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 4 | -0.20 score on a scale | Standard Error 0.071 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 8 | -0.22 score on a scale | Standard Error 0.073 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 12 | -0.18 score on a scale | Standard Error 0.076 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 24 | -0.37 score on a scale | Standard Error 0.069 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 36 | -0.25 score on a scale | Standard Error 0.079 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 48 | -0.35 score on a scale | Standard Error 0.075 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 60 | -0.29 score on a scale | Standard Error 0.075 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 72 | -0.31 score on a scale | Standard Error 0.077 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Day 7 | -0.25 score on a scale | Standard Error 0.088 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Day 14 | -0.14 score on a scale | Standard Error 0.102 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Day 21 | -0.30 score on a scale | Standard Error 0.093 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Day 30 | -0.31 score on a scale | Standard Error 0.069 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 2 | -0.11 score on a scale | Standard Error 0.055 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 4 | -0.17 score on a scale | Standard Error 0.063 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 8 | -0.19 score on a scale | Standard Error 0.053 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 12 | -0.21 score on a scale | Standard Error 0.067 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 24 | -0.25 score on a scale | Standard Error 0.067 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 36 | -0.23 score on a scale | Standard Error 0.066 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 48 | -0.23 score on a scale | Standard Error 0.074 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 60 | -0.19 score on a scale | Standard Error 0.065 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 72 | -0.15 score on a scale | Standard Error 0.076 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Day 7 | -0.38 score on a scale | Standard Error 0.091 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Day 14 | -0.44 score on a scale | Standard Error 0.125 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Day 21 | -0.38 score on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Day 30 | -0.46 score on a scale | Standard Error 0.111 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 2 | 0.01 score on a scale | Standard Error 0.034 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 4 | 0.01 score on a scale | Standard Error 0.034 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 8 | 0.05 score on a scale | Standard Error 0.034 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 12 | -0.01 score on a scale | Standard Error 0.034 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 24 | 0.01 score on a scale | Standard Error 0.034 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 36 | -0.01 score on a scale | Standard Error 0.034 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 48 | -0.01 score on a scale | Standard Error 0.034 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 60 | -0.04 score on a scale | Standard Error 0.034 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 72 | -0.01 score on a scale | Standard Error 0.034 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Day 7 | -0.02 score on a scale | Standard Error 0.034 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Day 14 | -0.02 score on a scale | Standard Error 0.038 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Day 21 | -0.02 score on a scale | Standard Error 0.038 |
| Placebo | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Day 30 | -0.02 score on a scale | Standard Error 0.034 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 48 | -0.78 score on a scale | Standard Error 0.089 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 2 | -0.45 score on a scale | Standard Error 0.121 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Day 21 | -0.35 score on a scale | Standard Error 0.094 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 4 | -0.92 score on a scale | Standard Error 0.138 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 60 | -0.64 score on a scale | Standard Error 0.099 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 8 | -1.20 score on a scale | Standard Error 0.136 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Day 14 | -0.94 score on a scale | Standard Error 0.118 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 12 | -1.18 score on a scale | Standard Error 0.14 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 72 | -0.74 score on a scale | Standard Error 0.094 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 24 | -1.34 score on a scale | Standard Error 0.145 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Day 30 | -0.42 score on a scale | Standard Error 0.115 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 36 | -1.64 score on a scale | Standard Error 0.147 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Day 7 | -0.65 score on a scale | Standard Error 0.097 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 48 | -1.74 score on a scale | Standard Error 0.146 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Day 21 | -0.67 score on a scale | Standard Error 0.123 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 60 | -1.91 score on a scale | Standard Error 0.144 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Day 14 | -0.67 score on a scale | Standard Error 0.108 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Hour 72 | -1.93 score on a scale | Standard Error 0.14 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Day 30 | -0.40 score on a scale | Standard Error 0.07 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Day 7 | -1.82 score on a scale | Standard Error 0.161 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Day 21 | -0.65 score on a scale | Standard Error 0.114 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Day 14 | -1.59 score on a scale | Standard Error 0.174 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Day 30 | -0.86 score on a scale | Standard Error 0.106 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Day 21 | -1.56 score on a scale | Standard Error 0.17 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Day 30 | -0.73 score on a scale | Standard Error 0.077 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Depressed Mood, Change at Day 30 | -1.89 score on a scale | Standard Error 0.14 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 48 | 0.01 score on a scale | Standard Error 0.034 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 2 | -0.59 score on a scale | Standard Error 0.125 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 2 | -0.67 score on a scale | Standard Error 0.126 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 48 | -1.11 score on a scale | Standard Error 0.131 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 4 | -1.00 score on a scale | Standard Error 0.127 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 2 | 0.07 score on a scale | Standard Error 0.053 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 8 | -1.04 score on a scale | Standard Error 0.124 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 4 | -0.93 score on a scale | Standard Error 0.138 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 12 | -0.98 score on a scale | Standard Error 0.128 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 2 | -0.06 score on a scale | Standard Error 0.055 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 24 | -1.16 score on a scale | Standard Error 0.123 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 8 | -1.05 score on a scale | Standard Error 0.142 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 36 | -1.09 score on a scale | Standard Error 0.129 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 4 | -0.01 score on a scale | Standard Error 0.066 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 12 | -1.01 score on a scale | Standard Error 0.144 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 60 | -1.28 score on a scale | Standard Error 0.12 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 2 | -0.03 score on a scale | Standard Error 0.034 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Hour 72 | -1.34 score on a scale | Standard Error 0.123 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 24 | -1.13 score on a scale | Standard Error 0.141 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Day 7 | -1.14 score on a scale | Standard Error 0.137 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 8 | -0.03 score on a scale | Standard Error 0.07 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Day 14 | -1.00 score on a scale | Standard Error 0.136 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 36 | -1.20 score on a scale | Standard Error 0.143 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Day 21 | -1.11 score on a scale | Standard Error 0.128 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 4 | -0.02 score on a scale | Standard Error 0.063 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt, Change at Day 30 | -1.20 score on a scale | Standard Error 0.112 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 48 | -1.24 score on a scale | Standard Error 0.144 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 2 | -0.19 score on a scale | Standard Error 0.062 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 12 | -0.09 score on a scale | Standard Error 0.085 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 4 | -0.28 score on a scale | Standard Error 0.062 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 60 | -1.51 score on a scale | Standard Error 0.133 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 8 | -0.32 score on a scale | Standard Error 0.062 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Day 21 | -0.02 score on a scale | Standard Error 0.038 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 12 | -0.36 score on a scale | Standard Error 0.062 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Hour 72 | -1.36 score on a scale | Standard Error 0.137 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 24 | -0.38 score on a scale | Standard Error 0.062 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 24 | -0.13 score on a scale | Standard Error 0.091 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 36 | -0.38 score on a scale | Standard Error 0.063 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Day 7 | -1.21 score on a scale | Standard Error 0.134 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 48 | -0.40 score on a scale | Standard Error 0.063 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 8 | -0.08 score on a scale | Standard Error 0.053 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 60 | -0.40 score on a scale | Standard Error 0.063 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Day 14 | -0.82 score on a scale | Standard Error 0.184 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Hour 72 | -0.40 score on a scale | Standard Error 0.063 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 36 | -0.31 score on a scale | Standard Error 0.094 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Day 7 | -0.30 score on a scale | Standard Error 0.062 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Day 21 | -0.83 score on a scale | Standard Error 0.158 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Day 14 | -0.32 score on a scale | Standard Error 0.069 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 4 | -0.05 score on a scale | Standard Error 0.034 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Day 21 | -0.36 score on a scale | Standard Error 0.068 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic, Change at Day 30 | -1.10 score on a scale | Standard Error 0.141 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Suicide, Change at Day 30 | -0.38 score on a scale | Standard Error 0.063 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 48 | -0.39 score on a scale | Standard Error 0.095 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 2 | -0.22 score on a scale | Standard Error 0.077 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 2 | -0.61 score on a scale | Standard Error 0.101 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 4 | -0.26 score on a scale | Standard Error 0.092 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 12 | -0.02 score on a scale | Standard Error 0.067 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 8 | -0.26 score on a scale | Standard Error 0.085 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 4 | -0.81 score on a scale | Standard Error 0.099 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 12 | -0.25 score on a scale | Standard Error 0.091 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 60 | -0.37 score on a scale | Standard Error 0.086 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 24 | -0.81 score on a scale | Standard Error 0.113 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 8 | -0.69 score on a scale | Standard Error 0.103 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 36 | -0.80 score on a scale | Standard Error 0.117 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 60 | 0.01 score on a scale | Standard Error 0.034 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 48 | -0.94 score on a scale | Standard Error 0.125 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 12 | -0.87 score on a scale | Standard Error 0.1 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 60 | -0.96 score on a scale | Standard Error 0.133 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Hour 72 | -0.59 score on a scale | Standard Error 0.105 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Hour 72 | -0.93 score on a scale | Standard Error 0.122 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 24 | -0.77 score on a scale | Standard Error 0.105 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Day 7 | -0.95 score on a scale | Standard Error 0.133 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 24 | -0.04 score on a scale | Standard Error 0.067 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Day 14 | -0.98 score on a scale | Standard Error 0.145 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 36 | -0.89 score on a scale | Standard Error 0.1 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Day 21 | -0.95 score on a scale | Standard Error 0.157 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Day 7 | -0.57 score on a scale | Standard Error 0.115 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Early, Change at Day 30 | -0.96 score on a scale | Standard Error 0.13 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 48 | -0.96 score on a scale | Standard Error 0.103 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 2 | -0.08 score on a scale | Standard Error 0.089 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 8 | -0.03 score on a scale | Standard Error 0.034 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 4 | -0.22 score on a scale | Standard Error 0.092 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 60 | -0.95 score on a scale | Standard Error 0.104 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 8 | -0.22 score on a scale | Standard Error 0.092 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Day 14 | -0.66 score on a scale | Standard Error 0.152 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 12 | -0.15 score on a scale | Standard Error 0.094 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Hour 72 | -1.08 score on a scale | Standard Error 0.09 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 24 | -0.84 score on a scale | Standard Error 0.105 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 36 | -0.15 score on a scale | Standard Error 0.067 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 36 | -0.91 score on a scale | Standard Error 0.105 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Day 7 | -0.92 score on a scale | Standard Error 0.114 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 48 | -0.88 score on a scale | Standard Error 0.109 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Day 21 | -0.76 score on a scale | Standard Error 0.149 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 60 | -0.96 score on a scale | Standard Error 0.101 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Day 14 | -0.63 score on a scale | Standard Error 0.139 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Hour 72 | -1.00 score on a scale | Standard Error 0.103 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Day 14 | -0.02 score on a scale | Standard Error 0.038 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Day 7 | -0.89 score on a scale | Standard Error 0.114 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Day 21 | -1.01 score on a scale | Standard Error 0.118 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Day 14 | -0.85 score on a scale | Standard Error 0.137 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms, Change at Day 30 | -0.62 score on a scale | Standard Error 0.135 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Day 21 | -0.79 score on a scale | Standard Error 0.138 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic, Change at Day 30 | -0.97 score on a scale | Standard Error 0.113 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 48 | -0.11 score on a scale | Standard Error 0.076 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Middle, Change at Day 30 | -0.91 score on a scale | Standard Error 0.123 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 2 | -0.15 score on a scale | Standard Error 0.092 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 2 | -0.03 score on a scale | Standard Error 0.092 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 2 | -0.30 score on a scale | Standard Error 0.077 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 4 | -0.13 score on a scale | Standard Error 0.096 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 4 | -0.39 score on a scale | Standard Error 0.096 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 8 | -0.23 score on a scale | Standard Error 0.09 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 12 | -0.03 score on a scale | Standard Error 0.034 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 12 | -0.23 score on a scale | Standard Error 0.092 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 8 | -0.37 score on a scale | Standard Error 0.087 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 24 | -0.59 score on a scale | Standard Error 0.101 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 4 | -0.28 score on a scale | Standard Error 0.071 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 36 | -0.45 score on a scale | Standard Error 0.105 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 12 | -0.45 score on a scale | Standard Error 0.091 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 48 | -0.61 score on a scale | Standard Error 0.1 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 60 | -0.19 score on a scale | Standard Error 0.065 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 60 | -0.63 score on a scale | Standard Error 0.1 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 24 | -0.54 score on a scale | Standard Error 0.084 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Hour 72 | -0.76 score on a scale | Standard Error 0.107 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 8 | -0.26 score on a scale | Standard Error 0.073 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Day 7 | -0.64 score on a scale | Standard Error 0.102 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 36 | -0.51 score on a scale | Standard Error 0.086 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Day 14 | -0.66 score on a scale | Standard Error 0.13 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 72 | 0.01 score on a scale | Standard Error 0.034 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Day 21 | -0.64 score on a scale | Standard Error 0.126 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 48 | -0.59 score on a scale | Standard Error 0.088 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insomnia - Late, Change at Day 30 | -0.72 score on a scale | Standard Error 0.101 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 12 | -0.34 score on a scale | Standard Error 0.076 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 48 | -1.71 score on a scale | Standard Error 0.141 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 2 | -0.41 score on a scale | Standard Error 0.109 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 60 | -0.71 score on a scale | Standard Error 0.093 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 4 | -0.72 score on a scale | Standard Error 0.131 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Hour 72 | -0.23 score on a scale | Standard Error 0.078 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 8 | -1.02 score on a scale | Standard Error 0.141 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Hour 72 | -0.75 score on a scale | Standard Error 0.082 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 12 | -1.18 score on a scale | Standard Error 0.152 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 24 | -0.32 score on a scale | Standard Error 0.069 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 24 | -1.33 score on a scale | Standard Error 0.151 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Day 7 | -0.67 score on a scale | Standard Error 0.095 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 36 | -1.65 score on a scale | Standard Error 0.149 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 24 | -0.05 score on a scale | Standard Error 0.034 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Day 14 | -0.79 score on a scale | Standard Error 0.094 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 60 | -2.04 score on a scale | Standard Error 0.136 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 36 | -0.30 score on a scale | Standard Error 0.08 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Hour 72 | -2.06 score on a scale | Standard Error 0.146 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Day 21 | -0.83 score on a scale | Standard Error 0.108 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Day 7 | -1.94 score on a scale | Standard Error 0.16 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Day 7 | -0.18 score on a scale | Standard Error 0.093 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Day 14 | -1.84 score on a scale | Standard Error 0.165 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms GI, Change at Day 30 | -0.73 score on a scale | Standard Error 0.087 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Day 21 | -1.70 score on a scale | Standard Error 0.178 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 48 | -0.30 score on a scale | Standard Error 0.076 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Work and Activities, Change at Day 30 | -2.00 score on a scale | Standard Error 0.145 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 2 | -0.15 score on a scale | Standard Error 0.079 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 2 | 0.06 score on a scale | Standard Error 0.089 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Day 30 | -0.01 score on a scale | Standard Error 0.034 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 4 | 0.00 score on a scale | Standard Error 0.086 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 4 | -0.35 score on a scale | Standard Error 0.094 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 8 | -0.13 score on a scale | Standard Error 0.086 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 60 | -0.34 score on a scale | Standard Error 0.075 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 12 | -0.29 score on a scale | Standard Error 0.083 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 8 | -0.45 score on a scale | Standard Error 0.093 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 24 | -0.17 score on a scale | Standard Error 0.092 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Day 14 | -0.39 score on a scale | Standard Error 0.127 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 36 | -0.38 score on a scale | Standard Error 0.084 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 12 | -0.75 score on a scale | Standard Error 0.093 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 48 | -0.24 score on a scale | Standard Error 0.081 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Hour 72 | -0.36 score on a scale | Standard Error 0.078 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 60 | -0.55 score on a scale | Standard Error 0.068 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 24 | -0.73 score on a scale | Standard Error 0.104 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Hour 72 | -0.44 score on a scale | Standard Error 0.075 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Day 7 | -0.55 score on a scale | Standard Error 0.074 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Hour 36 | -0.01 score on a scale | Standard Error 0.034 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Day 14 | -0.58 score on a scale | Standard Error 0.06 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 36 | -0.69 score on a scale | Standard Error 0.098 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Day 21 | -0.57 score on a scale | Standard Error 0.068 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Day 7 | -0.27 score on a scale | Standard Error 0.089 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Retardation, Change at Day 30 | -0.55 score on a scale | Standard Error 0.058 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 48 | -0.69 score on a scale | Standard Error 0.102 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 2 | -0.47 score on a scale | Standard Error 0.078 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Loss of Weight, Change at Day 21 | -0.50 score on a scale | Standard Error 0.132 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 4 | -0.65 score on a scale | Standard Error 0.082 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 60 | -0.91 score on a scale | Standard Error 0.105 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 8 | -0.71 score on a scale | Standard Error 0.081 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis, Change at Day 14 | -0.33 score on a scale | Standard Error 0.104 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 12 | -0.62 score on a scale | Standard Error 0.094 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Hour 72 | -1.05 score on a scale | Standard Error 0.113 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 24 | -0.74 score on a scale | Standard Error 0.083 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Insight, Change at Day 7 | -0.07 score on a scale | Standard Error 0.034 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Agitation, Change at Hour 36 | -0.66 score on a scale | Standard Error 0.094 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms General, Change at Day 7 | -0.93 score on a scale | Standard Error 0.103 |
Comparison: Depressed Mood, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.513295% CI: [-0.41, 0.21]MMRM
Comparison: Depressed Mood, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.167295% CI: [-0.61, 0.11]MMRM
Comparison: Depressed Mood, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.096395% CI: [-0.65, 0.05]MMRM
Comparison: Depressed Mood, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.480395% CI: [-0.49, 0.23]MMRM
Comparison: Depressed Mood, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.084495% CI: [-0.71, 0.05]MMRM
Comparison: Depressed Mood, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.132595% CI: [-0.68, 0.09]MMRM
Comparison: Depressed Mood, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.033295% CI: [-0.79, -0.03]MMRM
Comparison: Depressed Mood, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.127395% CI: [-0.67, 0.08]MMRM
Comparison: Depressed Mood, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.105995% CI: [-0.66, 0.06]MMRM
Comparison: Depressed Mood, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.068395% CI: [-0.82, 0.03]MMRM
Comparison: Depressed Mood, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.445895% CI: [-0.64, 0.28]MMRM
Comparison: Depressed Mood, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.290595% CI: [-0.21, 0.7]MMRM
Comparison: Depressed Mood, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.309695% CI: [-0.18, 0.55]MMRM
Comparison: Feeling of Guilt, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.192595% CI: [-0.55, 0.11]MMRM
Comparison: Feeling of Guilt, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.010195% CI: [-0.77, -0.11]MMRM
Comparison: Feeling of Guilt, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.154695% CI: [-0.56, 0.09]MMRM
Comparison: Feeling of Guilt, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.090195% CI: [-0.62, 0.05]MMRM
Comparison: Feeling of Guilt, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.071795% CI: [-0.62, 0.03]MMRM
Comparison: Feeling of Guilt, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.046895% CI: [-0.68, 0]MMRM
Comparison: Feeling of Guilt, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.222295% CI: [-0.56, 0.13]MMRM
Comparison: Feeling of Guilt, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.068295% CI: [-0.6, 0.02]MMRM
Comparison: Feeling of Guilt, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.014795% CI: [-0.72, -0.08]MMRM
Comparison: Feeling of Guilt, Day 7:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.083795% CI: [-0.68, 0.04]MMRM
Comparison: Feeling of Guilt, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.582895% CI: [-0.46, 0.26]MMRM
Comparison: Feeling of Guilt, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.567495% CI: [-0.43, 0.24]MMRM
Comparison: Feeling of Guilt, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.461395% CI: [-0.18, 0.4]MMRM
Comparison: Suicide, Hour 2:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.32495% CI: [-0.24, 0.08]MMRM
Comparison: Suicide, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.302395% CI: [-0.24, 0.08]MMRM
Comparison: Suicide, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.412795% CI: [-0.23, 0.09]MMRM
Comparison: Suicide, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.281995% CI: [-0.25, 0.07]MMRM
Comparison: Suicide, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.388495% CI: [-0.23, 0.09]MMRM
Comparison: Suicide, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.27595% CI: [-0.25, 0.07]MMRM
Comparison: Suicide, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.181195% CI: [-0.27, 0.05]MMRM
Comparison: Suicide, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.385495% CI: [-0.23, 0.09]MMRM
Comparison: Suicide, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.382295% CI: [-0.23, 0.09]MMRM
Comparison: Suicide, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.925595% CI: [-0.17, 0.15]MMRM
Comparison: Suicide, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.671495% CI: [-0.14, 0.22]MMRM
Comparison: Suicide, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.983895% CI: [-0.18, 0.18]MMRM
Comparison: Suicide, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.888495% CI: [-0.17, 0.15]MMRM
Comparison: Insomnia-Early, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.699695% CI: [-0.23, 0.16]MMRM
Comparison: Insomnia-Early, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.442695% CI: [-0.15, 0.33]MMRM
Comparison: Insomnia-Early, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.874395% CI: [-0.2, 0.24]MMRM
Comparison: Insomnia-Early, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.349895% CI: [-0.12, 0.35]MMRM
Comparison: Insomnia-Early, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.083995% CI: [-0.56, 0.04]MMRM
Comparison: Insomnia-Early, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.259595% CI: [-0.49, 0.13]MMRM
Comparison: Insomnia-Early, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.05695% CI: [-0.66, 0.01]MMRM
Comparison: Insomnia-Early, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.618795% CI: [-0.45, 0.27]MMRM
Comparison: Insomnia-Early, Hour 72 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.018795% CI: [-0.72, -0.07]MMRM
Comparison: Insomnia-Early, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.153195% CI: [-0.62, 0.1]MMRM
Comparison: Insomnia-Early, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.334195% CI: [-0.58, 0.2]MMRM
Comparison: Insomnia-Early, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.896995% CI: [-0.4, 0.46]MMRM
Comparison: Insomnia-Early, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.586295% CI: [-0.25, 0.44]MMRM
Comparison: Insomnia-Middle, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.377695% CI: [-0.13, 0.34]MMRM
Comparison: Insomnia-Middle, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.902995% CI: [-0.26, 0.23]MMRM
Comparison: Insomnia-Middle, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.617395% CI: [-0.18, 0.3]MMRM
Comparison: Insomnia-Middle, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.243395% CI: [-0.1, 0.39]MMRM
Comparison: Insomnia-Middle, Hour 24 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.023495% CI: [-0.59, -0.04]MMRM
Comparison: Insomnia-Middle, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.05495% CI: [-0.55, 0]MMRM
Comparison: Insomnia-Middle, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.040695% CI: [-0.58, -0.01]MMRM
Comparison: Insomnia-Middle, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.029595% CI: [-0.56, -0.03]MMRM
Comparison: Insomnia-Middle, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.092595% CI: [-0.5, 0.04]MMRM
Comparison: Insomnia-Middle, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.163195% CI: [-0.52, 0.09]MMRM
Comparison: Insomnia-Middle, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.221395% CI: [-0.6, 0.14]MMRM
Comparison: Insomnia-Middle, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.917595% CI: [-0.36, 0.39]MMRM
Comparison: Insomnia-Middle, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.676395% CI: [-0.4, 0.26]MMRM
Comparison: Insomnia-Late, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.380595% CI: [-0.13, 0.35]MMRM
Comparison: Insomnia-Late, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.607395% CI: [-0.19, 0.32]MMRM
Comparison: Insomnia-Late, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.784895% CI: [-0.27, 0.2]MMRM
Comparison: Insomnia-Late, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.903895% CI: [-0.25, 0.23]MMRM
Comparison: Insomnia-Late, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.686995% CI: [-0.32, 0.21]MMRM
Comparison: Insomnia-Late, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.927295% CI: [-0.26, 0.29]MMRM
Comparison: Insomnia-Late, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.693195% CI: [-0.31, 0.21]MMRM
Comparison: Insomnia-Late, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.826295% CI: [-0.29, 0.23]MMRM
Comparison: Insomnia-Late, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.074995% CI: [-0.54, 0.03]MMRM
Comparison: Insomnia-Late, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.192395% CI: [-0.45, 0.09]MMRM
Comparison: Insomnia-Late, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.032695% CI: [-0.73, -0.03]MMRM
Comparison: Insomnia-Late, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.44495% CI: [-0.47, 0.21]MMRM
Comparison: Insomnia-Late, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.705795% CI: [-0.32, 0.22]MMRM
Comparison: Work and Activities, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.286595% CI: [-0.42, 0.13]MMRM
Comparison: Work and Activities, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.947595% CI: [-0.33, 0.35]MMRM
Comparison: Work and Activities, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.18895% CI: [-0.61, 0.12]MMRM
Comparison: Work and Activities, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.59595% CI: [-0.51, 0.29]MMRM
Comparison: Work and Activities, Hour 24 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.963695% CI: [-0.39, 0.41]MMRM
Comparison: Work and Activities, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.583695% CI: [-0.5, 0.28]MMRM
Comparison: Work and Activities, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.156895% CI: [-0.63, 0.1]MMRM
Comparison: Work and Activities, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.01555% CI: [-0.79, -0.09]Wilcoxon (Mann-Whitney)
Comparison: Work and Activities, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.050495% CI: [-0.76, 0]MMRM
Comparison: Work and Activities, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.186595% CI: [-0.7, 0.14]MMRM
Comparison: Work and Activities, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.051895% CI: [-0.87, 0]MMRM
Comparison: Work and Activities, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.83395% CI: [-0.42, 0.53]MMRM
Comparison: Work and Activities, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.84495% CI: [-0.34, 0.42]MMRM
Comparison: Retardation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.460295% CI: [-0.15, 0.33]MMRM
Comparison: Retardation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.089195% CI: [-0.03, 0.43]MMRM
Comparison: Retardation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.308895% CI: [-0.11, 0.35]MMRM
Comparison: Retardation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.85695% CI: [-0.24, 0.2]MMRM
Comparison: Retardation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.970295% CI: [-0.24, 0.25]MMRM
Comparison: Retardation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.800195% CI: [-0.25, 0.2]MMRM
Comparison: Retardation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effectsp-value: 0.322395% CI: [-0.11, 0.32]MMRM
Comparison: Retardation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effectsp-value: 0.338595% CI: [-0.26, 0.09]MMRM
Comparison: Retardation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effectsp-value: 0.700395% CI: [-0.16, 0.24]MMRM
Comparison: Retardation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effectsp-value: 0.031195% CI: [-0.41, -0.02]MMRM
Comparison: Retardation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effectsp-value: 0.197695% CI: [-0.26, 0.06]MMRM
Comparison: Retardation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effectsp-value: 0.548995% CI: [-0.24, 0.13]MMRM
Comparison: Retardation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effectsp-value: 0.799295% CI: [-0.17, 0.13]MMRM
Comparison: Agitation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.057395% CI: [-0.4, 0.01]MMRM
Comparison: Agitation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.043195% CI: [-0.44, -0.01]MMRM
Comparison: Agitation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.00695% CI: [-0.52, -0.09]MMRM
Comparison: Agitation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.021595% CI: [-0.55, -0.04]MMRM
Comparison: Agitation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.042295% CI: [-0.44, -0.01]MMRM
Comparison: Agitation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.043395% CI: [-0.51, -0.01]MMRM
Comparison: Agitation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.005195% CI: [-0.57, -0.1]MMRM
Comparison: Agitation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.097395% CI: [-0.48, 0.04]MMRM
Comparison: Agitation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.003695% CI: [-0.63, -0.13]MMRM
Comparison: Agitation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.049895% CI: [-0.52, 0]MMRM
Comparison: Agitation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.511195% CI: [-0.39, 0.2]MMRM
Comparison: Agitation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.583995% CI: [-0.39, 0.22]MMRM
Comparison: Agitation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.190595% CI: [-0.33, 0.07]MMRM
Comparison: Anxiety Psychic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.176795% CI: [-0.54, 0.1]MMRM
Comparison: Anxiety Psychic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.518295% CI: [-0.47, 0.24]MMRM
Comparison: Anxiety Psychic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.39395% CI: [-0.53, 0.21]MMRM
Comparison: Anxiety Psychic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.521295% CI: [-0.5, 0.25]MMRM
Comparison: Anxiety Psychic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.474195% CI: [-0.5, 0.23]MMRM
Comparison: Anxiety Psychic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.448295% CI: [-0.51, 0.23]MMRM
Comparison: Anxiety Psychic, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.096395% CI: [-0.69, 0.06]MMRM
Comparison: Anxiety Psychic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.00395% CI: [-0.86, -0.18]MMRM
Comparison: Anxiety Psychic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.111695% CI: [-0.63, 0.07]MMRM
Comparison: Anxiety Psychic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.00495% CI: [-0.86, -0.17]MMRM
Comparison: Anxiety Psychic, Day 14 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.825395% CI: [-0.54, 0.43]MMRM
Comparison: Anxiety Psychic, Day 21 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.579595% CI: [-0.3, 0.53]MMRM
Comparison: Anxiety Psychic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.403295% CI: [-0.21, 0.51]MMRM
Comparison: Anxiety Somatic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.611795% CI: [-0.33, 0.2]MMRM
Comparison: Anxiety Somatic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.471695% CI: [-0.35, 0.16]MMRM
Comparison: Anxiety Somatic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.604195% CI: [-0.34, 0.2]MMRM
Comparison: Anxiety Somatic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.042495% CI: [-0.53, -0.01]MMRM
Comparison: Anxiety Somatic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.762295% CI: [-0.32, 0.23]MMRM
Comparison: Anxiety Somatic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.268995% CI: [-0.4, 0.11]MMRM
Comparison: Anxiety Somatic, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.21195% CI: [-0.44, 0.1]MMRM
Comparison: Anxiety Somatic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.587395% CI: [-0.34, 0.2]MMRM
Comparison: Anxiety Somatic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.04595% CI: [-0.46, -0.01]MMRM
Comparison: Anxiety Somatic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.084795% CI: [-0.57, 0.04]MMRM
Comparison: Anxiety Somatic, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.252295% CI: [-0.16, 0.6]MMRM
Comparison: Anxiety Somatic, day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.502695% CI: [-0.43, 0.21]MMRM
Comparison: Anxiety Somatic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.591195% CI: [-0.38, 0.22]MMRM
Comparison: Somatic Symptoms Gastrointestinal, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.5895% CI: [-0.18, 0.31]MMRM
Comparison: Somatic Symptoms Gastrointestinal, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.675495% CI: [-0.31, 0.2]MMRM
Comparison: Somatic Symptoms Gastrointestinal, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.100695% CI: [-0.04, 0.42]MMRM
Comparison: Somatic Symptoms Gastrointestinal, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.358895% CI: [-0.13, 0.35]MMRM
Comparison: Somatic Symptoms Gastrointestinal, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.580795% CI: [-0.28, 0.16]MMRM
Comparison: Somatic Symptoms Gastrointestinal, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.424195% CI: [-0.13, 0.31]MMRM
Comparison: Somatic Symptoms Gastrointestinal, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.798495% CI: [-0.26, 0.2]MMRM
Comparison: Somatic Symptoms Gastrointestinal, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.873295% CI: [-0.22, 0.26]MMRM
Comparison: Somatic Symptoms Gastrointestinal, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.862195% CI: [-0.19, 0.23]MMRM
Comparison: Somatic Symptoms Gastrointestinal, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.108795% CI: [-0.45, 0.05]MMRM
Comparison: Somatic Symptoms Gastrointestinal, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.215395% CI: [-0.41, 0.09]MMRM
Comparison: Somatic Symptoms Gastrointestinal, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.142295% CI: [-0.51, 0.07]MMRM
Comparison: Somatic Symptoms Gastrointestinal, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.721195% CI: [-0.19, 0.27]MMRM
Comparison: Somatic Symptoms General, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.822495% CI: [-0.18, 0.23]MMRM
Comparison: Somatic Symptoms General, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.636295% CI: [-0.31, 0.19]MMRM
Comparison: Somatic Symptoms General, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.609495% CI: [-0.31, 0.18]MMRM
Comparison: Somatic Symptoms General, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.045795% CI: [-0.49, 0]MMRM
Comparison: Somatic Symptoms General, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.569195% CI: [-0.36, 0.2]MMRM
Comparison: Somatic Symptoms General, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.294295% CI: [-0.4, 0.12]MMRM
Comparison: Somatic Symptoms General, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.538995% CI: [-0.35, 0.19]MMRM
Comparison: Somatic Symptoms General, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.406195% CI: [-0.4, 0.16]MMRM
Comparison: Somatic Symptoms General, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.09995% CI: [-0.56, 0.05]MMRM
Comparison: Somatic Symptoms General, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.010895% CI: [-0.63, -0.08]MMRM
Comparison: Somatic Symptoms General, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.088995% CI: [-0.59, 0.04]MMRM
Comparison: Somatic Symptoms General, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.372195% CI: [-0.18, 0.49]MMRM
Comparison: Somatic Symptoms General, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.551395% CI: [-0.36, 0.2]MMRM
Comparison: Genital Symptoms, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.074895% CI: [-0.01, 0.26]MMRM
Comparison: Genital Symptoms, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.354595% CI: [-0.09, 0.25]MMRM
Comparison: Genital Symptoms, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.653195% CI: [-0.14, 0.23]MMRM
Comparison: Genital Symptoms, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.75295% CI: [-0.26, 0.19]MMRM
Comparison: Genital Symptoms, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.886195% CI: [-0.26, 0.23]MMRM
Comparison: Genital Symptoms, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.32895% CI: [-0.38, 0.13]MMRM
Comparison: Genital Symptoms, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.112395% CI: [-0.46, 0.05]MMRM
Comparison: Genital Symptoms, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.254195% CI: [-0.36, 0.1]MMRM
Comparison: Genital Symptoms, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.01195% CI: [-0.66, -0.09]MMRM
Comparison: Genital Symptoms, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.77295% CI: [-0.36, 0.27]MMRM
Comparison: Genital Symptoms, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.631195% CI: [-0.52, 0.32]MMRM
Comparison: Genital Symptoms, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.687795% CI: [-0.5, 0.33]MMRM
Comparison: Genital Symptoms, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.246595% CI: [-0.15, 0.58]MMRM
Comparison: Hypochondriasis, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.127995% CI: [-0.36, 0.05]MMRM
Comparison: Hypochondriasis, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.394695% CI: [-0.26, 0.1]MMRM
Comparison: Hypochondriasis, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.669495% CI: [-0.23, 0.15]MMRM
Comparison: Hypochondriasis, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.111395% CI: [-0.36, 0.04]MMRM
Comparison: Hypochondriasis, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.581195% CI: [-0.13, 0.23]MMRM
Comparison: Hypochondriasis, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.679495% CI: [-0.25, 0.17]MMRM
Comparison: Hypochondriasis, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.603195% CI: [-0.14, 0.25]MMRM
Comparison: Hypochondriasis, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.667395% CI: [-0.24, 0.15]MMRM
Comparison: Hypochondriasis, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.647295% CI: [-0.25, 0.16]MMRM
Comparison: Hypochondriasis, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.865495% CI: [-0.26, 0.22]MMRM
Comparison: Hypochondriasis, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.210195% CI: [-0.48, 0.11]MMRM
Comparison: Hypochondriasis, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.712895% CI: [-0.3, 0.21]MMRM
Comparison: Hypochondriasis, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.329795% CI: [-0.27, 0.09]MMRM
Comparison: Loss of weight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.449395% CI: [-0.08, 0.19]MMRM
Comparison: Loss of weight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.071795% CI: [-0.01, 0.31]MMRM
Comparison: Loss of Weight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.105495% CI: [-0.02, 0.24]MMRM
Comparison: Loss of Weight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.040895% CI: [0.01, 0.36]MMRM
Comparison: Loss of Weight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.023395% CI: [0.03, 0.38]MMRM
Comparison: Loss of Weight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.36195% CI: [-0.09, 0.26]MMRM
Comparison: Loss of Weight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.235895% CI: [-0.08, 0.32]MMRM
Comparison: Loss of Weight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.949295% CI: [-0.16, 0.17]MMRM
Comparison: Loss of Weight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.435295% CI: [-0.28, 0.12]MMRM
Comparison: Loss of Weight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.117695% CI: [-0.05, 0.44]MMRM
Comparison: Loss of Weight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.781295% CI: [-0.3, 0.4]MMRM
Comparison: Loss of Weight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.508595% CI: [-0.48, 0.24]MMRM
Comparison: Loss of Weight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.827495% CI: [-0.28, 0.34]MMRM
Comparison: Insight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.367595% CI: [-0.13, 0.05]MMRM
Comparison: Insight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.181895% CI: [-0.15, 0.03]MMRM
Comparison: Insight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.082695% CI: [-0.17, 0.01]MMRM
Comparison: Insight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.643695% CI: [-0.11, 0.07]MMRM
Comparison: Insight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.182795% CI: [-0.15, 0.03]MMRM
Comparison: Insight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.985995% CI: [-0.09, 0.09]MMRM
Comparison: Insight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.667295% CI: [-0.07, 0.11]MMRM
Comparison: Insight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.203195% CI: [-0.03, 0.15]MMRM
Comparison: Insight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.666495% CI: [-0.07, 0.11]MMRM
Comparison: Insight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.341795% CI: [-0.13, 0.05]MMRM
Comparison: Insight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.662295% CI: [-0.12, 0.08]MMRM
Comparison: Insight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.908795% CI: [-0.11, 0.09]MMRM
Comparison: Insight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.826395% CI: [-0.08, 0.1]MMRM
Secondary
Change From Baseline in HAM-D Total Score
The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Time frame: Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14 and 21
Population: All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in HAM-D Total Score | Change at Hour 12 | -7.96 score on a scale | Standard Error 0.758 |
| Placebo | Change From Baseline in HAM-D Total Score | Change at Hour 48 | -10.59 score on a scale | Standard Error 0.86 |
| Placebo | Change From Baseline in HAM-D Total Score | Change at Hour 8 | -7.44 score on a scale | Standard Error 0.738 |
| Placebo | Change From Baseline in HAM-D Total Score | Change at Hour 72 | -11.83 score on a scale | Standard Error 0.829 |
| Placebo | Change From Baseline in HAM-D Total Score | Change at Hour 24 | -9.81 score on a scale | Standard Error 0.82 |
| Placebo | Change From Baseline in HAM-D Total Score | Change at Day 7 | -10.74 score on a scale | Standard Error 1.042 |
| Placebo | Change From Baseline in HAM-D Total Score | Change at Hour 4 | -6.55 score on a scale | Standard Error 0.701 |
| Placebo | Change From Baseline in HAM-D Total Score | Change at Day 14 | -11.40 score on a scale | Standard Error 0.989 |
| Placebo | Change From Baseline in HAM-D Total Score | Change at Hour 36 | -10.45 score on a scale | Standard Error 0.833 |
| Placebo | Change From Baseline in HAM-D Total Score | Change at Day 21 | -13.26 score on a scale | Standard Error 1.022 |
| Placebo | Change From Baseline in HAM-D Total Score | Change at Hour 2 | -4.00 score on a scale | Standard Error 0.598 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Total Score | Change at Day 21 | -13.59 score on a scale | Standard Error 1.041 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Total Score | Change at Hour 2 | -4.60 score on a scale | Standard Error 0.595 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Total Score | Change at Hour 4 | -7.32 score on a scale | Standard Error 0.702 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Total Score | Change at Hour 8 | -8.38 score on a scale | Standard Error 0.74 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Total Score | Change at Hour 12 | -9.10 score on a scale | Standard Error 0.762 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Total Score | Change at Hour 24 | -11.42 score on a scale | Standard Error 0.827 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Total Score | Change at Hour 36 | -12.31 score on a scale | Standard Error 0.843 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Total Score | Change at Hour 48 | -13.00 score on a scale | Standard Error 0.873 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Total Score | Change at Hour 72 | -15.31 score on a scale | Standard Error 0.841 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Total Score | Change at Day 7 | -13.98 score on a scale | Standard Error 1.061 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Total Score | Change at Day 14 | -13.43 score on a scale | Standard Error 1.013 |
Comparison: Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.421695% CI: [-2.06, 0.87]MMRM
Comparison: Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.394795% CI: [-2.57, 1.02]MMRM
Comparison: Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.32895% CI: [-2.86, 0.96]MMRM
Comparison: Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.252295% CI: [-3.12, 0.83]MMRM
Comparison: Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.143195% CI: [-3.78, 0.55]MMRM
Comparison: Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.099195% CI: [-4.06, 0.36]MMRM
Comparison: Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.038995% CI: [-4.71, -0.13]MMRM
Comparison: Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.002295% CI: [-5.67, -1.28]MMRM
Comparison: Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.025595% CI: [-6.08, -0.4]MMRM
Comparison: Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.137595% CI: [-4.73, 0.66]MMRM
Comparison: Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.81795% CI: [-3.11, 2.46]MMRM
Secondary
Change From Baseline in HAM-D Total Score at Day 30
The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Time frame: Baseline, Day 30
Population: All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in HAM-D Total Score at Day 30 | -15.23 score on a scale | Standard Error 0.934 |
| SAGE-547 90 μg/kg/h | Change From Baseline in HAM-D Total Score at Day 30 | -14.69 score on a scale | Standard Error 0.955 |
Comparison: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.67195% CI: [-1.98, 3.07]MMRM
Secondary
Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score
The GAD-7 is a participant-rated, generalized anxiety symptom severity scale. Scoring for GAD-7 generalized anxiety is calculated by assigning scores of 0 = not at all sure, 1 = several days, 2 = over half the days, and 3 = nearly every day to the response categories. The GAD-7 total score for the seven items ranges from 0 to 21, where a score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and 15 to 21 = severe anxiety. The GAD-7 total score was calculated as the sum of the seven individual item scores. A negative change from baseline indicates less anxiety. A positive change from baseline indicates more anxiety.
Time frame: Baseline, Hour 60, Days 7, 14, 21 and 30
Population: All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score | Day 7 | -7.67 score on a scale | Standard Error 0.858 |
| Placebo | Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score | Day 21 | -8.92 score on a scale | Standard Error 1.053 |
| Placebo | Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score | Day 14 | -7.90 score on a scale | Standard Error 0.937 |
| Placebo | Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score | Day 30 | -9.89 score on a scale | Standard Error 0.884 |
| Placebo | Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score | Hour 60 | -6.41 score on a scale | Standard Error 0.814 |
| SAGE-547 90 μg/kg/h | Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score | Day 30 | -10.20 score on a scale | Standard Error 0.913 |
| SAGE-547 90 μg/kg/h | Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score | Hour 60 | -7.58 score on a scale | Standard Error 0.85 |
| SAGE-547 90 μg/kg/h | Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score | Day 7 | -8.43 score on a scale | Standard Error 0.879 |
| SAGE-547 90 μg/kg/h | Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score | Day 14 | -9.76 score on a scale | Standard Error 0.961 |
| SAGE-547 90 μg/kg/h | Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score | Day 21 | -10.88 score on a scale | Standard Error 1.081 |
Comparison: Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.263695% CI: [-3.24, 0.9]MMRM
Comparison: Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.489795% CI: [-2.96, 1.43]MMRM
Comparison: Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.134195% CI: [-4.3, 0.59]MMRM
Comparison: Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.169195% CI: [-4.76, 0.85]MMRM
Comparison: Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.p-value: 0.785295% CI: [-2.6, 1.97]MMRM
Secondary
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response
The CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions.
Time frame: Hour 60, Days 7 and 30
Population: All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Hour 60 | 55.8 percentage of participants |
| Placebo | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 7 | 54.7 percentage of participants |
| Placebo | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 30 | 78.8 percentage of participants |
| SAGE-547 90 μg/kg/h | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Hour 60 | 79.6 percentage of participants |
| SAGE-547 90 μg/kg/h | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 7 | 70.0 percentage of participants |
| SAGE-547 90 μg/kg/h | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 30 | 81.3 percentage of participants |
Comparison: Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.p-value: 0.000595% CI: [2, 12.5]GEE method
Comparison: Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.p-value: 0.047895% CI: [1, 8.4]GEE method
Comparison: Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.p-value: 0.439995% CI: [0.5, 4.6]GEE method
Secondary
Percentage of Participants With HAM-D Remission
HAM-D remission is defined as having a HAM-D total score of ≤7. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Time frame: Hour 60, Days 7 and 30
Population: All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With HAM-D Remission | Hour 60 | 38.5 percentage of participants |
| Placebo | Percentage of Participants With HAM-D Remission | Day 7 | 32.1 percentage of participants |
| Placebo | Percentage of Participants With HAM-D Remission | Day 30 | 61.5 percentage of participants |
| SAGE-547 90 μg/kg/h | Percentage of Participants With HAM-D Remission | Hour 60 | 61.2 percentage of participants |
| SAGE-547 90 μg/kg/h | Percentage of Participants With HAM-D Remission | Day 7 | 56.0 percentage of participants |
| SAGE-547 90 μg/kg/h | Percentage of Participants With HAM-D Remission | Day 30 | 47.9 percentage of participants |
Comparison: Hour 60: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.p-value: 0.003395% CI: [1.5, 7.9]GEE method
Comparison: Day 7: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.p-value: 0.004695% CI: [1.5, 9.3]GEE method
Comparison: Day 30: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.p-value: 0.308595% CI: [0.3, 1.5]GEE method
Secondary
Percentage of Participants With HAM-D Response
The HAM-D response is defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.
Time frame: Hour 60, Days 7 and 30
Population: All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With HAM-D Response | Hour 60 | 59.6 percentage of participants |
| Placebo | Percentage of Participants With HAM-D Response | Day 7 | 50.9 percentage of participants |
| Placebo | Percentage of Participants With HAM-D Response | Day 30 | 78.8 percentage of participants |
| SAGE-547 90 μg/kg/h | Percentage of Participants With HAM-D Response | Hour 60 | 75.5 percentage of participants |
| SAGE-547 90 μg/kg/h | Percentage of Participants With HAM-D Response | Day 7 | 66.0 percentage of participants |
| SAGE-547 90 μg/kg/h | Percentage of Participants With HAM-D Response | Day 30 | 70.8 percentage of participants |
Comparison: Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.p-value: 0.016895% CI: [1.2, 6.7]GEE method
Comparison: Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.p-value: 0.048295% CI: [1, 6.6]GEE method
Comparison: Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.p-value: 0.585795% CI: [0.3, 2]GEE method
Secondary
Percentage of Participants With Treatment Emergent Adverse Event (TEAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.
Time frame: Up to approximately 37 days
Population: The safety set included all randomized participants who started the study drug infusion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Treatment Emergent Adverse Event (TEAE) | 45.3 percentage of participants |
| SAGE-547 90 μg/kg/h | Percentage of Participants With Treatment Emergent Adverse Event (TEAE) | 49.0 percentage of participants |
Secondary
Time to Change in Antidepressant Medication
The time to first start or increase in the dose and time to first stop or decrease in the dose of any antidepressant medication.
Time frame: Up to approximately 37 days
Population: All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to Change in Antidepressant Medication | Time to first start/increase in dose | 8 days |
| SAGE-547 90 μg/kg/h | Time to Change in Antidepressant Medication | Time to first start/increase in dose | 10 days |
| SAGE-547 90 μg/kg/h | Time to Change in Antidepressant Medication | Time to first stop/decrease in dose | 18 days |