Trial · NCT02614547
A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression
NCT02614547, Phase 2, Completed, Supernus Pharmaceuticals, Inc.; results first posted 2021-09-13
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ConductScience Library. A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression. Trials, record NCT02614547. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02614547
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression
- NCT number
- NCT02614547
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Conditions
- Severe Postpartum Depression
- Interventions
- SAGE-547, Placebo
- First posted
- 2015-11-25
- Last updated
- 2025-09-15
- Results first posted
- 2021-09-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline at End of Treatment Period (at 60 Hours) in Hamilton Rating Scale for Depression (HAM-D) Total Score | Baseline, 60 Hours | 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. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression. |
| Secondary | Percentage of Participants With HAM-D Response | 60 Hours, Days 7 and 30 | The 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 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. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression. |
| Secondary | Percentage of Participants With HAM-D Remission | 60 Hours, Days 7, and 30 | The HAM-D remission was defined as having a HAM-D total score of less than or equal to (\<=)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. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression. |
| Secondary | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline, 60 Hours, 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 indicate more severe depression. A negative change from baseline indicate less severe depression. A positive change from baseline indicates more severe depression. |
| Secondary | Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Response | 60 Hours, 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, and by definition, was evaluated against baseline conditions. CGI-I response was defined as having a CGI-I score of "very much improved" or "much improved". |
| Secondary | Change From Baseline in HAM-D Bech 6 Subscale | Baseline, 60 Hours, Days 7 and 30 | The HAM-D Bech 6 subscale score was calculated as the sum of the following six items: depressed mood, feelings of guilt, work and activities, retardation, psychic anxiety, and 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 scale of 0 to 100, 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 to 60 Hours in the HAM-D Individual Item Scores | Baseline, 60 Hours | 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 in Generalized Anxiety Disorder 7-item Scale (GAD-7) Total Score | Baseline, 60 Hours, Day 7 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. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to 30 days | An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did 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 was 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. |
Source ClinicalTrials.gov
Outcomes9
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 End of Treatment Period (at 60 Hours) in Hamilton Rating Scale for Depression (HAM-D) Total Score | Baseline, 60 Hours | Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With HAM-D Response | 60 Hours, Days 7 and 30 | Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HAM-D Remission | 60 Hours, Days 7, and 30 | Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed'' signifies participants evaluable for this outcome measure at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline, 60 Hours, Days 7 and 30 | Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed'' signifies participants evaluable for this outcome measure at specified time points. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Response | 60 Hours, Days 7 and 30 | Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed'' signifies participants evaluable for this outcome measure at specified time points. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in HAM-D Bech 6 Subscale | Baseline, 60 Hours, Days 7 and 30 | Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 60 Hours in the HAM-D Individual Item Scores | Baseline, 60 Hours | Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Generalized Anxiety Disorder 7-item Scale (GAD-7) Total Score | Baseline, 60 Hours, Day 7 and 30 | Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to 30 days | Safety population included all randomized participants who started the study drug infusion. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group74
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 End of Treatment Period (at 60 Hours) in Hamilton Rating Scale for Depression (HAM-D) Total Score | Placebo | -8.75 | Standard Error 2.800 | score on a scale | |
| Change From Baseline at End of Treatment Period (at 60 Hours) in Hamilton Rating Scale for Depression (HAM-D) Total Score | SAGE-547 | -20.97 | Standard Error 2.938 | score on a scale | |
| Percentage of Participants With HAM-D Response | Placebo | 60 Hours | 36.4 | percentage of participants | |
| Percentage of Participants With HAM-D Response | SAGE-547 | 60 Hours | 70.0 | percentage of participants | |
| Percentage of Participants With HAM-D Response | Placebo | Day 7 | 20.0 | percentage of participants | |
| Percentage of Participants With HAM-D Response | SAGE-547 | Day 7 | 80.0 | percentage of participants | |
| Percentage of Participants With HAM-D Response | Placebo | Day 30 | 27.3 | percentage of participants | |
| Percentage of Participants With HAM-D Response | SAGE-547 | Day 30 | 70.0 | percentage of participants | |
| Percentage of Participants With HAM-D Remission | Placebo | 60 Hours | 9.1 | percentage of participants | |
| Percentage of Participants With HAM-D Remission | SAGE-547 | 60 Hours | 70.0 | percentage of participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 11 | |
| Overall Study | STARTED | SAGE-547 | 10 | |
| Overall Study | COMPLETED | Placebo | 11 | |
| Overall Study | COMPLETED | SAGE-547 | 10 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | SAGE-547 | 0 |
Source ClinicalTrials.gov
Adverse events44
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 | Dizziness | Nervous system disorders | Placebo | 3 | 11 | |
| other | Dizziness | Nervous system disorders | SAGE-547 | 2 | 10 | |
| other | Somnolence | Nervous system disorders | Placebo | 0 | 11 | |
| other | Somnolence | Nervous system disorders | SAGE-547 | 2 | 10 | |
| other | Dizziness postural | Nervous system disorders | Placebo | 0 | 11 | |
| other | Dizziness postural | Nervous system disorders | SAGE-547 | 1 | 10 | |
| other | Sedation | Nervous system disorders | Placebo | 0 | 11 | |
| other | Sedation | Nervous system disorders | SAGE-547 | 1 | 10 | |
| other | Abnormal dreams | Psychiatric disorders | Placebo | 2 | 11 | |
| other | Abnormal dreams | Psychiatric disorders | SAGE-547 | 0 | 10 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 11 |
| Total, all-cause mortality | SAGE-547 | 0 | 10 |
| Total, other adverse events | Placebo | 8 | 11 |
| Total, other adverse events | SAGE-547 | 4 | 10 |
| Total, serious adverse events | Placebo | 0 | 11 |
| Total, serious adverse events | SAGE-547 | 0 | 10 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SAGE-547 vs Placebo: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Trial comparisons |
| SAGE-547 vs Placebo: deaths from any cause | Trial comparisons |
| SAGE-547 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.
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