Trial · NCT02978326
A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression
NCT02978326, Phase 3, Completed, Biogen; results first posted 2021-12-16
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ConductScience Library. A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression. Trials, record NCT02978326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02978326
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression
- NCT number
- NCT02978326
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 276 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Postpartum Depression
- Interventions
- SAGE-217 15/20 mg Oral Solution, Placebo, SAGE 217 30 mg Capsules
- First posted
- 2016-11-30
- Last updated
- 2023-12-15
- Results first posted
- 2021-12-16
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 | Parts A and B: Baseline, Day 15 | The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. 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 HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression. |
| Secondary | Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Part B: Baseline, Days 3, 8, 21 and 45 | The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. 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 HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression. |
| Secondary | Parts A and B: Percentage of Participants With HAM-D Response | Part B: Days 3, 8, 15, 21 and 45 | HAM-D Response was defined as having a 50 percent (%) or greater reduction from Baseline in HAM-D total score. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours \[morning\]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression. |
| Secondary | Parts A and B: Percentage of Participants With HAM-D Remission | Part B: Days 3, 8, 15, 21 and 45 | HAM-D Remission was defined as a HAM-D total score of less than or equal to (\<=)7. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours \[morning\]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression. |
| Secondary | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Part B: Baseline, Days 3, 8, 15, 21 and 45 | HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. HAM-D subscales: Core subscale (symptoms-depressed mood, feelings of guilt, suicide, work and activities, and retardation ); Anxiety subscale (symptoms-anxiety \[psychic and somatic\], somatic symptoms \[gastrointestinal and general\], hypochondriasis, loss of weight); Bech-6 subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general); Meier subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic). Each item was scored in a range of 0 to 2 or 0 to 4, higher scores=greater degree of depression. Subscale scores were calculated as the sum of the individual item scores comprising each subscale. Scores were transformed to a scale of 0 to 100, with higher scores indicated more severe depression. A negative change from Baseline indicates less depression. |
| Secondary | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Part B: Baseline, Days 3, 8, 15, 21 and 45 | The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Individual items on the scale were scored in a range of 0 to 2 or 0 to 4. 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 were 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 indicated a greater degree of depression. A negative change from Baseline indicates less depression. |
| Secondary | Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | Part B: Baseline, Days 3, 8, 15, 21 and 45 | The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression. |
| Secondary | Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Part B: Days 3, 8, 15, 21 and 45 | The Clinical Global Impression - Improvement (CGI-I) item of the CGI scale uses a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 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. CGI response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved). The percentage of participants with overall improvement in post-treatment condition, rated by investigator as very much improved (CGI-I score of 1) or much improved (CGI-I score of 2) is reported. |
| Secondary | Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Part B: Baseline, Days 3, 8, 15, 21 and 45 | The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The individual items were scored in a range of 0 (not present) to 4 (very severe). The HAM-A total score was calculated as the sum of the 14 individual item scores and could range from 0 to 56 where a score of \<17=mild severity; 18-24= mild to moderate severity and 25-30=moderate to severe severity. A negative change from Baseline indicates less anxiety. |
| Secondary | Parts A and B: Percentage of Participants With MADRS Response | Part B: Days 3, 8, 15, 21 and 45 | MADRS response was defined as having a 50% or greater reduction from Baseline in MADRS total score. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 | Parts A and B: Baseline, Day 15 | Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Part B: Baseline, Days 3, 8, 21 and 45 | Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Parts A and B: Percentage of Participants With HAM-D Response | Part B: Days 3, 8, 15, 21 and 45 | Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Parts A and B: Percentage of Participants With HAM-D Remission | Part B: Days 3, 8, 15, 21 and 45 | Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Part B: Baseline, Days 3, 8, 15, 21 and 45 | Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Part B: Baseline, Days 3, 8, 15, 21 and 45 | Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | Part B: Baseline, Days 3, 8, 15, 21 and 45 | Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Part B: Days 3, 8, 15, 21 and 45 | Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Part B: Baseline, Days 3, 8, 15, 21 and 45 | Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Parts A and B: Percentage of Participants With MADRS Response | Part B: Days 3, 8, 15, 21 and 45 | Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. | percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group401
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 | Part B: Placebo | -13.6 | Standard Error 1.07 | score on a scale | |
| Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 | Part B: SAGE 217 30 mg Capsules | -17.8 | Standard Error 1.04 | score on a scale | |
| Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Part B: Placebo | Change From Baseline at Day 3 | -9.8 | Standard Error 0.95 | score on a scale |
| Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Part B: SAGE 217 30 mg Capsules | Change From Baseline at Day 3 | -12.5 | Standard Error 0.93 | score on a scale |
| Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Part B: Placebo | Change From Baseline at Day 8 | -12.9 | Standard Error 1.03 | score on a scale |
| Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Part B: SAGE 217 30 mg Capsules | Change From Baseline at Day 8 | -16.3 | Standard Error 1.00 | score on a scale |
| Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Part B: Placebo | Change From Baseline at Day 21 | -14.4 | Standard Error 1.11 | score on a scale |
| Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Part B: SAGE 217 30 mg Capsules | Change From Baseline at Day 21 | -17.6 | Standard Error 1.09 | score on a scale |
| Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Part B: Placebo | Change From Baseline at Day 45 | -15.1 | Standard Error 1.06 | score on a scale |
| Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Part B: SAGE 217 30 mg Capsules | Change From Baseline at Day 45 | -19.2 | Standard Error 1.02 | score on a scale |
1 to 10 of 401Source ClinicalTrials.gov
See all 401 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (Up to 75 Days) | STARTED | Part A: SAGE-217 15/20 mg Oral Solution | 1 | |
| Part A (Up to 75 Days) | STARTED | Part B: Placebo | 0 | |
| Part A (Up to 75 Days) | STARTED | Part B: SAGE 217 30 mg Capsules | 0 | |
| Part A (Up to 75 Days) | COMPLETED | Part A: SAGE-217 15/20 mg Oral Solution | 1 | |
| Part A (Up to 75 Days) | COMPLETED | Part B: Placebo | 0 | |
| Part A (Up to 75 Days) | COMPLETED | Part B: SAGE 217 30 mg Capsules | 0 | |
| Part A (Up to 75 Days) | NOT COMPLETED | Part A: SAGE-217 15/20 mg Oral Solution | 0 | |
| Part A (Up to 75 Days) | NOT COMPLETED | Part B: Placebo | 0 | |
| Part A (Up to 75 Days) | NOT COMPLETED | Part B: SAGE 217 30 mg Capsules | 0 | |
| Part B (Up to 45 Days) | STARTED | Part A: SAGE-217 15/20 mg Oral Solution | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events39
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | Part A: SAGE-217 15/20 mg Oral Solution | 0 | 1 | |
| other | Somnolence | Nervous system disorders | Part B: Placebo | 8 | 73 | |
| other | Somnolence | Nervous system disorders | Part B: SAGE 217 30 mg Capsules | 12 | 78 | |
| other | Headache | Nervous system disorders | Part A: SAGE-217 15/20 mg Oral Solution | 0 | 1 | |
| other | Headache | Nervous system disorders | Part B: Placebo | 9 | 73 | |
| other | Headache | Nervous system disorders | Part B: SAGE 217 30 mg Capsules | 7 | 78 | |
| other | Dizziness | Nervous system disorders | Part A: SAGE-217 15/20 mg Oral Solution | 0 | 1 | |
| other | Dizziness | Nervous system disorders | Part B: Placebo | 4 | 73 | |
| other | Dizziness | Nervous system disorders | Part B: SAGE 217 30 mg Capsules | 6 | 78 | |
| other | Upper respiratory tract infection | Infections and infestations | Part A: SAGE-217 15/20 mg Oral Solution | 0 | 1 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: SAGE-217 15/20 mg Oral Solution | 0 | 1 |
| Total, all-cause mortality | Part B: Placebo | 0 | 73 |
| Total, all-cause mortality | Part B: SAGE 217 30 mg Capsules | 0 | 78 |
| Total, other adverse events | Part A: SAGE-217 15/20 mg Oral Solution | 1 | 1 |
| Total, other adverse events | Part B: Placebo | 26 | 73 |
| Total, other adverse events | Part B: SAGE 217 30 mg Capsules | 31 | 78 |
| Total, serious adverse events | Part A: SAGE-217 15/20 mg Oral Solution | 0 | 1 |
| Total, serious adverse events | Part B: Placebo | 1 | 73 |
| Total, serious adverse events | Part B: SAGE 217 30 mg Capsules | 1 | 78 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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