Trial · NCT04442503
A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)
NCT04442503, Phase 3, Completed, Biogen; results first posted 2023-06-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD). Trials, record NCT04442503. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04442503
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)
- NCT number
- NCT04442503
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 200 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Depression, Postpartum
- Interventions
- SAGE-217, Placebo
- First posted
- 2020-06-22
- Last updated
- 2023-11-30
- Other registries' IDs
- eudract:2020-001424-34
- Results first posted
- 2023-06-22
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 (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 | Baseline and Day 15 | The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of 17 individual items related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), retardation, agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total score is the sum of the 17 individual items, ranges from 0 to 52; where a higher score indicates more depression. Negative change from baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for the analysis. |
| Secondary | Change From Baseline in the 17-item HAM-D Total Score | Baseline, Days 3, 28 and 45 | The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of 17 individual items related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), retardation, agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total score is the sum of the 17 individual items, ranges from 0 to 52; where a higher score indicates more depression. Negative change from baseline indicates improvement. MMRM was used for the analysis. |
| Secondary | Change From Baseline in Clinical Global Impressions - Severity Scale (CGI-S) Score | Baseline and Day 15 | The CGI-S is a 7-point Likert scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who had the same diagnosis. A participant was assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7= extremely ill participants. A lower score indicates a better outcome. A negative change from baseline indicates improvement. MMRM was used for the analysis. |
| Secondary | Percentage of Participants With HAM-D Response | Days 15 and 45 | The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of 17 individual items related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), retardation, agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total score is the sum of the 17 individual items, ranges from 0 to 52; where a higher score indicates more depression. Negative change from baseline indicates improvement. HAM-D response was defined as a ≥50% reduction in HAM-D total score from baseline. |
| Secondary | Percentage of Participants With HAM-D Remission | Days 15 and 45 | The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of 17 individual items related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), retardation, agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total score is the sum of the 17 individual items, ranges from 0 to 52; where a higher score indicates more depression. Negative change from baseline indicates improvement. HAM-D remission was defined as having a HAM-D total score of ≤7. |
| Secondary | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 15 | The CGI-I employs 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 is due entirely to drug treatment. Response choices include 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 posttreatment assessments. By definition, all CGI-I assessments are 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 Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Baseline and Day 15 | The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each 14-items were 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 HAM-A total score was calculated as the sum of the 14 individual item scores. The scoring for HAM-A is calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56 where \<17 indicated mild severity, 18 to 24, mild to moderate severity, and 25 to 30, moderate to severe severity. A negative change from baseline in HAM-A total score indicated improvement. |
| Secondary | Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score | Baseline and Day 15 | The MADRS is a 10-item diagnostic 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 is rated on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change from baseline in MADRS total score indicated improvement. |
| Secondary | Change From Baseline in HAM-D Subscale | Baseline and Day 15 | 17-item HAM-D scale is used for severity of depression. HAM-D subscales: Core subscale(depressed mood, feelings of guilt, suicide, work and activities, and retardation/20x100; Anxiety subscale\[anxiety(psychic and somatic), somatic symptoms (gastrointestinal and general), hypochondriasis, and insight loss of weight\]/18x100; Bech-6 subscale(depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general)/22x100; Maier score(depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic)/24x100. Each item was scored in range of 0 to 2 or 0 to 4 (0=none to 2 or 4=severe), higher score=more depression. 4 Subscale scores were calculated as sum of individual rating scores related to each subscale, divided by total possible score within subscale, multiplied by 100. Scores were transformed to scale of 0 to 100, with higher scores=more severe depression. Negative CFB=improvement. MMRM was used for analysis. |
| Secondary | Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score | Baseline, Days 3, 8,15, 21, 28 and 45 | The EPDS is a self-rated depressive symptom severity scale specific to the perinatal period which consists of 10 individual items. Each item is rated on a 4-point scale ranging from 0 to 3 points. The EPDS total score is calculated as the sum of the 10 individual item scores, ranging from 0 points to 30 points with a higher score indicating more depression. A negative change indicates improvement. |
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 (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 | Baseline and Day 15 | Full Analysis Set(FAS)=randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM for Anxiety(HAM-A), Montgomery Åsberg Depression Rating Scale(MADRS), Clinical Global Impressions-Severity(CGI-S), Edinburgh Postnatal Depression Scale(EPDS) and Patient Health Questionnaire(PHQ-9), or at least 1 post-baseline value of CGI-I. Number analyzed=number of participants with data available for analyses. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the 17-item HAM-D Total Score | Baseline, Days 3, 28 and 45 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number analyzed is the number of participants with data available for analysis. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impressions - Severity Scale (CGI-S) Score | Baseline and Day 15 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number analyzed is the number of participants with data available for analyses. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With HAM-D Response | Days 15 and 45 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number analyzed is the number of participants available for analyses. Percentages are rounded off to the nearest whole number. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HAM-D Remission | Days 15 and 45 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number analyzed is the number of participants with data available for analyses. Percentages are rounded off to the nearest whole number. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 15 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants with data available for analyses. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Baseline and Day 15 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number of participants analyzed is the number of participants with data available for analyses. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score | Baseline and Day 15 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Overall number analyzed are the number of participants available for analysis. Number analyzed is the number of participants with data available for analyses. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in HAM-D Subscale | Baseline and Day 15 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number analyzed is the number of participants with data available for analyses. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score | Baseline, Days 3, 8,15, 21, 28 and 45 | FAS included all randomized participants who received any amount of IP and had valid baseline and at least one valid post-baseline total score in at least one of HAM-D, HAM-A, MADRS, CGI-S, EPDS and PHQ-9, or at least 1 post-baseline value of CGI-I. Number analyzed is the number of participants with data available for analyses. | score on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 | Placebo | Baseline | 28.8 | Standard Deviation 2.34 | score on a scale |
| Change From Baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 | SAGE-217 50 mg | Baseline | 28.6 | Standard Deviation 2.49 | score on a scale |
| Change From Baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 | Placebo | Change from Baseline at Day 15 | -11.4 | Standard Deviation 8.50 | score on a scale |
| Change From Baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 | SAGE-217 50 mg | Change from Baseline at Day 15 | -15.6 | Standard Deviation 7.62 | score on a scale |
| Change From Baseline in the 17-item HAM-D Total Score | Placebo | Baseline | 28.8 | Standard Deviation 2.34 | score on a scale |
| Change From Baseline in the 17-item HAM-D Total Score | SAGE-217 50 mg | Baseline | 28.6 | Standard Deviation 2.49 | score on a scale |
| Change From Baseline in the 17-item HAM-D Total Score | Placebo | Change from Baseline at Day 3 | -6.3 | Standard Deviation 6.78 | score on a scale |
| Change From Baseline in the 17-item HAM-D Total Score | SAGE-217 50 mg | Change from Baseline at Day 3 | -9.5 | Standard Deviation 7.40 | score on a scale |
| Change From Baseline in the 17-item HAM-D Total Score | Placebo | Change from Baseline at Day 28 | -13.5 | Standard Deviation 8.77 | score on a scale |
| Change From Baseline in the 17-item HAM-D Total Score | SAGE-217 50 mg | Change from Baseline at Day 28 | -16.3 | Standard Deviation 8.34 | score on a scale |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 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 | 101 | |
| Overall Study | STARTED | SAGE-217 50 mg | 99 | |
| Overall Study | Number of Participants Received Investigational Product (IP) | Placebo | 98 | |
| Overall Study | Number of Participants Received Investigational Product (IP) | SAGE-217 50 mg | 98 | |
| Overall Study | COMPLETED | Placebo | 86 | |
| Overall Study | COMPLETED | SAGE-217 50 mg | 84 | |
| Overall Study | NOT COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | SAGE-217 50 mg | 15 |
Source ClinicalTrials.gov
Adverse events76
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 | Placebo | 5 | 98 | |
| other | Somnolence | Nervous system disorders | SAGE-217 50 mg | 26 | 98 | |
| other | Dizziness | Nervous system disorders | Placebo | 10 | 98 | |
| other | Dizziness | Nervous system disorders | SAGE-217 50 mg | 13 | 98 | |
| other | Sedation | Nervous system disorders | Placebo | 1 | 98 | |
| other | Sedation | Nervous system disorders | SAGE-217 50 mg | 11 | 98 | |
| other | Headache | Nervous system disorders | Placebo | 13 | 98 | |
| other | Headache | Nervous system disorders | SAGE-217 50 mg | 9 | 98 | |
| other | Memory impairment | Nervous system disorders | Placebo | 0 | 98 | |
| other | Memory impairment | Nervous system disorders | SAGE-217 50 mg | 3 | 98 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 98 |
| Total, all-cause mortality | SAGE-217 50 mg | 0 | 98 |
| Total, other adverse events | Placebo | 52 | 98 |
| Total, other adverse events | SAGE-217 50 mg | 64 | 98 |
| Total, serious adverse events | Placebo | 0 | 98 |
| Total, serious adverse events | SAGE-217 50 mg | 2 | 98 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37491938 | DERIVED |
Source 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SAGE-217 50 mg vs Placebo: deaths from any cause | Trial comparisons |
| SAGE-217 50 mg 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/NCT04442503
GET https://conductscience.org/api/trials/v1/NCT04442503/results?page=2