Trial · NCT02942004

A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)

NCT02942004, Phase 3, Completed, Supernus Pharmaceuticals, Inc.; results first posted 2019-06-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B). Trials, record NCT02942004. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02942004

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
NCT number: NCT02942004
Status: Completed
Phases: Phase 3
Enrollment: 138 participants, actual
Lead sponsor: Supernus Pharmaceuticals, Inc.
Conditions: Postpartum Depression
Interventions: Placebo, SAGE-547 60 μg/kg/h, SAGE-547 90 μg/kg/h
First posted: 2016-10-21
Last updated: 2025-10-14
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 the 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	The 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, Hour 2, Hour 4, Hour 8, Hour 12, Hour 24, Hour 36, Hour 48, Hour 60, Hour 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 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. CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved).
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 outcomes

Outcomes12

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 the 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, Hour 2, Hour 4, Hour 8, Hour 12, Hour 24, Hour 36, Hour 48, Hour 60, Hour 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	LEAST_SQUARES_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 outcomes

Results by group770

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 the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score	Placebo		-14.04	Standard Error 1.148	score on a scale
Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score	SAGE-547 60 μg/kg/h		-19.54	Standard Error 1.231	score on a scale
Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score	SAGE-547 90 μg/kg/h		-17.72	Standard Error 1.193	score on a scale
Change From Baseline in HAM-D Total Score at Day 30	Placebo		-13.82	Standard Error 1.324	score on a scale
Change From Baseline in HAM-D Total Score at Day 30	SAGE-547 60 μg/kg/h		-19.45	Standard Error 1.435	score on a scale
Change From Baseline in HAM-D Total Score at Day 30	SAGE-547 90 μg/kg/h		-17.62	Standard Error 1.400	score on a scale
Change From Baseline in HAM-D Total Score	Placebo	Change at Hour 2	-5.04	Standard Error 0.669	score on a scale
Change From Baseline in HAM-D Total Score	SAGE-547 60 μg/kg/h	Change at Hour 2	-4.99	Standard Error 0.721	score on a scale
Change From Baseline in HAM-D Total Score	SAGE-547 90 μg/kg/h	Change at Hour 2	-4.89	Standard Error 0.707	score on a scale
Change From Baseline in HAM-D Total Score	Placebo	Change at Hour 4	-6.88	Standard Error 0.841	score on a scale

1 to 10 of 770Source ClinicalTrials.gov

See all 770 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	46
Overall Study	STARTED	SAGE-547 60 μg/kg/h	47
Overall Study	STARTED	SAGE-547 90 μg/kg/h	45
Overall Study	Participants Who Received Study Drug	Placebo	43
Overall Study	Participants Who Received Study Drug	SAGE-547 60 μg/kg/h	38
Overall Study	Participants Who Received Study Drug	SAGE-547 90 μg/kg/h	41
Overall Study	COMPLETED	Placebo	42
Overall Study	COMPLETED	SAGE-547 60 μg/kg/h	35
Overall Study	COMPLETED	SAGE-547 90 μg/kg/h	36
Overall Study	NOT COMPLETED	Placebo	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events30

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
other	Dry mouth	Gastrointestinal disorders	Placebo	0	43
other	Dry mouth	Gastrointestinal disorders	SAGE-547 60 μg/kg/h	4	38
other	Dry mouth	Gastrointestinal disorders	SAGE-547 90 μg/kg/h	0	41
other	Nausea	Gastrointestinal disorders	Placebo	3	43
other	Nausea	Gastrointestinal disorders	SAGE-547 60 μg/kg/h	1	38
other	Nausea	Gastrointestinal disorders	SAGE-547 90 μg/kg/h	0	41
other	Infusion site pain	General disorders	Placebo	1	43
other	Infusion site pain	General disorders	SAGE-547 60 μg/kg/h	1	38
other	Infusion site pain	General disorders	SAGE-547 90 μg/kg/h	4	41
other	Dizziness	Nervous system disorders	Placebo	1	43

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	43
Total, all-cause mortality	SAGE-547 60 μg/kg/h	0	38
Total, all-cause mortality	SAGE-547 90 μg/kg/h	0	41
Total, other adverse events	Placebo	9	43
Total, other adverse events	SAGE-547 60 μg/kg/h	17	38
Total, other adverse events	SAGE-547 90 μg/kg/h	13	41
Total, serious adverse events	Placebo	0	43
Total, serious adverse events	SAGE-547 60 μg/kg/h	1	38
Total, serious adverse events	SAGE-547 90 μg/kg/h	0	41

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30177236	DERIVED	PubMed
33181049	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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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