Trial · NCT02942017
A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)
NCT02942017, Phase 3, Completed, Supernus Pharmaceuticals, Inc.; results first posted 2019-06-13
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ConductScience Library. A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C). Trials, record NCT02942017. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02942017
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)
- NCT number
- NCT02942017
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 108 participants, actual
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Conditions
- Postpartum Depression
- Interventions
- Placebo, SAGE-547 90 μg/kg/h
- First posted
- 2016-10-21
- Last updated
- 2025-09-15
- Results first posted
- 2019-06-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline at 60 Hours in 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score | Baseline, Hour 60 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HAM-D Total Score at Day 30 | Baseline, Day 30 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HAM-D Total Score | Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14 and 21 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With HAM-D Response | Hour 60, Days 7 and 30 | 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HAM-D Remission | Hour 60, Days 7 and 30 | 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. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in HAM-D Bech 6 Subscale | Baseline, Hour 60, Days 7 and 30 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Baseline, Hour 60, Days 7 and 30 | 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. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Hour 60, Days 7 and 30 | 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. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score | Baseline, Hour 60, Days 7, 14, 21 and 30 | 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. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group513
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline at 60 Hours in 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score | Placebo | -12.12 | Standard Error 0.773 | score on a scale | |
| Change From Baseline at 60 Hours in 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score | SAGE-547 90 μg/kg/h | -14.62 | Standard Error 0.782 | score on a scale | |
| Change From Baseline in HAM-D Total Score at Day 30 | Placebo | -15.23 | Standard Error 0.934 | score on a scale | |
| Change From Baseline in HAM-D Total Score at Day 30 | SAGE-547 90 μg/kg/h | -14.69 | Standard Error 0.955 | score on a scale | |
| Change From Baseline in HAM-D Total Score | Placebo | Change at Hour 2 | -4.00 | Standard Error 0.598 | score on a scale |
| Change From Baseline in HAM-D Total Score | SAGE-547 90 μg/kg/h | Change at Hour 2 | -4.60 | Standard Error 0.595 | score on a scale |
| Change From Baseline in HAM-D Total Score | Placebo | Change at Hour 4 | -6.55 | Standard Error 0.701 | score on a scale |
| Change From Baseline in HAM-D Total Score | SAGE-547 90 μg/kg/h | Change at Hour 4 | -7.32 | Standard Error 0.702 | score on a scale |
| Change From Baseline in HAM-D Total Score | Placebo | Change at Hour 8 | -7.44 | Standard Error 0.738 | score on a scale |
| Change From Baseline in HAM-D Total Score | SAGE-547 90 μg/kg/h | Change at Hour 8 | -8.38 | Standard Error 0.740 | score on a scale |
1 to 10 of 513Source ClinicalTrials.gov
See all 513 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 54 | |
| Overall Study | STARTED | SAGE-547 90 μg/kg/h | 54 | |
| Overall Study | Treated | Placebo | 53 | |
| Overall Study | Treated | SAGE-547 90 μg/kg/h | 51 | |
| Overall Study | COMPLETED | Placebo | 52 | |
| Overall Study | COMPLETED | SAGE-547 90 μg/kg/h | 48 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | SAGE-547 90 μg/kg/h | 6 |
Source ClinicalTrials.gov
Adverse events16
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 | Nausea | Gastrointestinal disorders | Placebo | 2 | 53 | |
| other | Nausea | Gastrointestinal disorders | SAGE-547 90 μg/kg/h | 5 | 51 | |
| other | Fatigue | General disorders | Placebo | 2 | 53 | |
| other | Fatigue | General disorders | SAGE-547 90 μg/kg/h | 3 | 51 | |
| other | Infusion site pain | General disorders | Placebo | 2 | 53 | |
| other | Infusion site pain | General disorders | SAGE-547 90 μg/kg/h | 5 | 51 | |
| other | Dizziness | Nervous system disorders | Placebo | 4 | 53 | |
| other | Dizziness | Nervous system disorders | SAGE-547 90 μg/kg/h | 5 | 51 | |
| other | Headache | Nervous system disorders | Placebo | 6 | 53 | |
| other | Headache | Nervous system disorders | SAGE-547 90 μg/kg/h | 9 | 51 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 53 |
| Total, all-cause mortality | SAGE-547 90 μg/kg/h | 0 | 51 |
| Total, other adverse events | Placebo | 13 | 53 |
| Total, other adverse events | SAGE-547 90 μg/kg/h | 21 | 51 |
| Total, serious adverse events | Placebo | 0 | 53 |
| Total, serious adverse events | SAGE-547 90 μg/kg/h | 1 | 51 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SAGE-547 90 μg/kg/h vs Placebo: deaths from any cause | Trial comparisons |
| SAGE-547 90 μg/kg/h vs Placebo: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02942017
GET https://conductscience.org/api/trials/v1/NCT02942017/results?page=2