Trial · NCT03864614
A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
NCT03864614, Phase 3, Completed, Biogen; results first posted 2024-07-18
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ConductScience Library. A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD). Trials, record NCT03864614. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03864614
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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 Adult Participants With Major Depressive Disorder (MDD)
- NCT number
- NCT03864614
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,515 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Major Depressive Disorder
- Interventions
- SAGE-217
- First posted
- 2019-03-06
- Last updated
- 2024-08-27
- Results first posted
- 2024-07-18
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to 52 Weeks | An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. For Part A, a TEAE was defined as an AE with onset after the first dose of SAGE-217. |
| Primary | Part B: Number of Participants With TEAEs | Up to 46 Weeks | An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. For Part B, a TEAE was defined as an AE with onset on or after the first dose of SAGE-217 in MDD-303B for the participants who received placebo + ADT in parent study, or an AE with onset on or after the ICF signoff in MDD-303B for the participants who received SAGE-217 + ADT in parent study. |
| Primary | Part A: Number of Participants With Suicidal Ideation (SI) or Suicidal Behavior (SB) as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline up to 52 Weeks (Study Period 1-5) | C-SSRS scale consisted of a baseline evaluation that assessed lifetime experience as well as past 24-month experience of participants for SI and SB and a postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of SI and SB as well as numeric ratings for severity of ideation, if present. The C-SSRS SI items included: 1. wish to be dead, 2. non-specific active suicidal thoughts, 3. active SI with any methods, 4. active SI with some intent, and 5. active SI with a specific plan (5 being the most severe). C-SSRS SB items included 1. preparatory acts or behavior, 2. aborted attempt, 3. interrupted attempt, 4. actual attempt (non-fatal), and 5. completed suicide (5 being worst). Participants with at least one SI question answered Yes or at least one SB question answered Yes post-baseline for the specific period is counted under SI or SB respectively. |
| Primary | Part B: Number of Participants With Suicidal Ideation (SI) and Suicidal Behavior (SB) as Assessed by the C-SSRS | Baseline up to 46 Weeks (Study Period 1-5) | C-SSRS scale consisted of a baseline evaluation that assessed lifetime experience as well as past 24-month experience of participants for SI and SB and a postbaseline (PB) evaluation that focused on suicidality since last study visit. C-SSRS included "yes" or "no"' responses for assessment of SI and SB as well as numeric ratings for severity of ideation, if present. The C-SSRS SI items included: 1. wish to be dead, 2. non-specific active suicidal thoughts, 3. active SI with any methods, 4. active SI with some intent, and 5. active SI with a specific plan (5 being the most severe). C-SSRS SB items included 1. preparatory acts or behavior, 2. aborted attempt, 3. interrupted attempt, 4. actual attempt (non-fatal), and 5. completed suicide (5 being worst). Participants with at least one SI question answered Yes or at least one SB question answered Yes post-baseline for the specific period is counted under SI or SB respectively. |
| Secondary | Parts A and B: Time to First Repeat Treatment With SAGE-217 | Up to 52 Weeks | For Part A, the first day of the first repeat treatment is Treatment Cycle 2 Day 1. For Part B, participants who had "placebo + ADT" in the parent study (217-MDD-305), the first repeat treatment of SAGE-217 was the second treatment within MDD-303B. Participants who had SAGE-217 + ADT in the parent study (217-MDD-305), the first repeat treatment of SAGE-217 was the first treatment within MDD-303B. For Part A, as prespecified, data for this outcome measure was collected for Sage-217 High-dose Cohort and Sage-217 30 mg Cohort (Low Dose + Dose Switch). For Part B, data for this outcome measure is presented as per the designated arms in the parent study (217-MDD-305). Analysis used Kaplan-Meier estimates where the participants with no repeat treatment were censored. |
| Secondary | Parts A and B: Number of Participants Who Achieved the Requirements for Repeat Treatment for SAGE-217 | Up to 52 Weeks | Participants who continued in the study beyond 56 days from the last study drug dose (in parent study for Part B) and had a HAMD-17 total score ≥20 between the end of first treatment cycle and start of next treatment cycle qualified for repeat treatment for SAGE-217. The 17-item HAM-D was used for measuring severity of depression. It comprised individual ratings of 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 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. The total score can range from 0 to 52, and higher scores indicated a greater degree of depression. For Part B, data for this outcome measure is presented as per the designated arms in the parent study (217-MDD-305). |
| Secondary | Parts A and B: Number of Repeat Treatment Cycles of SAGE-217 for Each Participant | Up to 52 Weeks | The response of initial treatment and/or repeat treatment was assessed by HAMD-17. The 17-item HAM-D scale was used for measuring severity of depression. The HAM-D comprised individual ratings of following symptoms scored in range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Following symptoms were scored in range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. total score range=0 to 52, and higher scores indicated greater degree of depression. Participants who had a HAM-D total score \>=20 within the protocol were eligible for at least 1 repeat treatment in study. For Part B, data for this outcome measure is presented as per the designated arms in parent study (217-MDD-305). Participants who did not have any re-treatment were included with number of re-treatments equal to 0. |
| Secondary | Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 in Study Period 1 | Baseline, Day 15 in Study Period 1 | The 17-item HAM-D scale was used for measuring severity of depression. The 17-item HAM-D comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), 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. Each item is scored in a range of 0 to 2 or 0 to 4. The total score ranges from 0 to 52 with higher scores indicating a greater degree of depression. A negative change from baseline indicates improvement. A study period is a treatment cycle (treatment period+14-day follow-up) plus the observational period (until next treatment cycle or end of study, whichever is earlier) immediately following it. |
| Secondary | Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 of Each Treatment Cycle | Baseline, Day 15 of treatment cycles 2, 3, 4, and 5 | The 17-item HAM-D scale was used for measuring severity of depression. The 17-item HAM-D comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), 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. Each item is scored in a range of 0 to 2 or 0 to 4. The total score ranges from 0 to 52 with higher scores indicating a greater degree of depression. A negative change from baseline indicates improvement. Each 14-day treatment period plus corresponding 14-day follow-up period was considered a treatment cycle. |
| Secondary | Part B: Change From Baseline in the HAMD-17 Total Score at Day 15 of Each Treatment (Initial and/or Repeat Treatment) Cycle | Baseline, Day 15 of Study Period 1, 2, 3, 4, and 5 | The 17-item HAM-D scale was used to measure the severity of depression. The 17-item HAM-D comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), 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. Each item is scored in a range of 0 to 2 or 0 to 4. The total score ranges from 0 to 52 with higher scores indicating a greater degree of depression. A negative change from baseline indicates improvement. Study period is defined as treatment cycle (28 days) followed by immediate observation period (maximum 46 weeks), until the first dose of the subsequent treatment cycle. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to 52 Weeks | Safety Set included all participants who were administered SAGE-217. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With TEAEs | Up to 46 Weeks | Study-specific Safety Set included all participants who signed the ICF for 217-MDD-303B and had at least 1 dosing of SAGE-217 within 217-MDD-303B. Data for Part B was collected and reported in a single arm for each participant who started treatment as specified. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: Number of Participants With Suicidal Ideation (SI) or Suicidal Behavior (SB) as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline up to 52 Weeks (Study Period 1-5) | Safety Set included all participants who were administered SAGE-217. For Baseline: Number analyzed is participants of safety set who received SAGE-217 in corresponding study period; For Post-baseline: Number analyzed is participants with data available for analysis at a specific timepoint. A study period is a treatment cycle (treatment period+14-day follow-up) plus the observational period (until next treatment cycle or end of study, whichever is earlier) immediately following it. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Suicidal Ideation (SI) and Suicidal Behavior (SB) as Assessed by the C-SSRS | Baseline up to 46 Weeks (Study Period 1-5) | Period-Specific Safety Set included all participants who signed ICF for 217-MDD-303B and were dosed in respective Study Period. A Study Period is a treatment cycle followed by the immediate observation period until the first dose of the subsequent treatment cycle. Data for Part B was collected and reported in a single arm for each participant who started treatment as specified. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Parts A and B: Time to First Repeat Treatment With SAGE-217 | Up to 52 Weeks | For Part A: FAS included all participants in the Safety Set who had HAMD-17 (change from baseline \>=50%) response at Treatment Cycle 1 Day 15 and the discontinuation from study date, if it existed, was after the end of Treatment Cycle 1. For Part B: Safety Set included all participants who received a dose of SAGE-217 either in the parent study 217-MDD-305 or within this protocol 217-MDD-303B. | days | MEDIAN |
| SECONDARY | Parts A and B: Number of Participants Who Achieved the Requirements for Repeat Treatment for SAGE-217 | Up to 52 Weeks | For Part A: FAS included all participants in the Safety Set who had HAMD-17 response at Treatment Cycle 1 Day 15 and the discontinuation from study date, if it existed, was after the end of Treatment Cycle 1. For Part B: FAS included all participants in the study-specific safety set (dosed at least once within this protocol) who had at least 1 HAMD-17 total score available after the first dose of SAGE-217 within 217-MDD-303B. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Parts A and B: Number of Repeat Treatment Cycles of SAGE-217 for Each Participant | Up to 52 Weeks | For Part A: FAS included all participants in safety set who had HAMD-17 response at Treatment Cycle 1 Day 15 and discontinuation from study date, if it existed, was after end of Treatment Cycle 1. For Part B: FAS included all participants in study-specific safety set (dosed at least once within this protocol) who had at least 1 HAMD-17 total score available after first dose of SAGE-217 within 217-MDD-303B. | repeat treatment cycles | MEAN |
| SECONDARY | Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 in Study Period 1 | Baseline, Day 15 in Study Period 1 | The Safety Set was defined as all participants who received SAGE-217. Overall number analyzed is the number of participants with data available for analysis at a specified timepoint. | score on a scale | MEAN |
| SECONDARY | Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 of Each Treatment Cycle | Baseline, Day 15 of treatment cycles 2, 3, 4, and 5 | FAS included all participants in the Safety Set who had HAMD-17 response at Treatment Cycle 1 Day 15 and a discontinuation from study date, if it existed, was after the end of Treatment Cycle 1. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at a specific timepoint. | score on a scale | MEAN |
| SECONDARY | Part B: Change From Baseline in the HAMD-17 Total Score at Day 15 of Each Treatment (Initial and/or Repeat Treatment) Cycle | Baseline, Day 15 of Study Period 1, 2, 3, 4, and 5 | FAS included all participants who signed the ICF for 217-MDD-303B and had at least 1 dosing of SAGE-217 within 217-MDD-303B and had at least 1 HAMD-17 total score available after the first dose of SAGE-217 within 217-MDD-303B. Overall number of participants analyzed is participants in FAS who were dosed in the specific period. Data for this outcome measure was collected and analyzed as per study period. | score on a scale | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group198
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Part A: Sage-217 High-dose Cohort | 374 | Participants | ||
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Part A: Sage-217 Low-dose Cohort | 437 | Participants | ||
| Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Part A: Sage-217 Dose-switch Cohort | 57 | Participants | ||
| Part B: Number of Participants With TEAEs | Part B: Sage-217 | 87 | Participants | ||
| Part A: Number of Participants With Suicidal Ideation (SI) or Suicidal Behavior (SB) as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | Part A: Sage-217 High-dose Cohort | Study Period 1: SI: Baseline | 262 | Participants | |
| Part A: Number of Participants With Suicidal Ideation (SI) or Suicidal Behavior (SB) as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | Part A: Sage-217 Low-dose Cohort | Study Period 1: SI: Baseline | 264 | Participants | |
| Part A: Number of Participants With Suicidal Ideation (SI) or Suicidal Behavior (SB) as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | Part A: Sage-217 Dose-switch Cohort | Study Period 1: SI: Baseline | 29 | Participants | |
| Part A: Number of Participants With Suicidal Ideation (SI) or Suicidal Behavior (SB) as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | Part A: Sage-217 High-dose Cohort | Study Period 1: SI: Post-baseline | 128 | Participants | |
| Part A: Number of Participants With Suicidal Ideation (SI) or Suicidal Behavior (SB) as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | Part A: Sage-217 Low-dose Cohort | Study Period 1: SI: Post-baseline | 141 | Participants | |
| Part A: Number of Participants With Suicidal Ideation (SI) or Suicidal Behavior (SB) as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | Part A: Sage-217 Dose-switch Cohort | Study Period 1: SI: Post-baseline | 14 | Participants |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Sage-217 High-dose Cohort | 513 | |
| Overall Study | STARTED | Part A: Sage-217 Low-dose Cohort | 645 | |
| Overall Study | STARTED | Part A: Sage-217 Dose-switch Cohort | 80 | |
| Overall Study | STARTED | Part B: Sage-217 | 277 | |
| Overall Study | Dosed With SAGE-217 Within This Study | Part A: Sage-217 High-dose Cohort | 513 | |
| Overall Study | Dosed With SAGE-217 Within This Study | Part A: Sage-217 Low-dose Cohort | 645 | |
| Overall Study | Dosed With SAGE-217 Within This Study | Part A: Sage-217 Dose-switch Cohort | 80 | |
| Overall Study | Dosed With SAGE-217 Within This Study | Part B: Sage-217 | 118 | |
| Overall Study | COMPLETED | Part A: Sage-217 High-dose Cohort | 213 | |
| Overall Study | COMPLETED | Part A: Sage-217 Low-dose Cohort | 236 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events252
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 High-dose Cohort | 102 | 513 | |
| other | Somnolence | Nervous system disorders | Part A: Sage-217 Low-dose Cohort | 76 | 645 | |
| other | Somnolence | Nervous system disorders | Part A: Sage-217 Dose-switch Cohort | 10 | 80 | |
| other | Somnolence | Nervous system disorders | Part B: Sage-217 All Participants | 19 | 118 | |
| other | Headache | Nervous system disorders | Part A: Sage-217 High-dose Cohort | 61 | 513 | |
| other | Headache | Nervous system disorders | Part A: Sage-217 Low-dose Cohort | 90 | 645 | |
| other | Headache | Nervous system disorders | Part A: Sage-217 Dose-switch Cohort | 13 | 80 | |
| other | Headache | Nervous system disorders | Part B: Sage-217 All Participants | 13 | 118 | |
| other | Dizziness | Nervous system disorders | Part A: Sage-217 High-dose Cohort | 78 | 513 | |
| other | Dizziness | Nervous system disorders | Part A: Sage-217 Low-dose Cohort | 47 | 645 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Sage-217 High-dose Cohort | 0 | 513 |
| Total, all-cause mortality | Part A: Sage-217 Low-dose Cohort | 1 | 645 |
| Total, all-cause mortality | Part A: Sage-217 Dose-switch Cohort | 0 | 80 |
| Total, all-cause mortality | Part B: Sage-217 All Participants | 0 | 118 |
| Total, other adverse events | Part A: Sage-217 High-dose Cohort | 371 | 513 |
| Total, other adverse events | Part A: Sage-217 Low-dose Cohort | 435 | 645 |
| Total, other adverse events | Part A: Sage-217 Dose-switch Cohort | 57 | 80 |
| Total, other adverse events | Part B: Sage-217 All Participants | 87 | 118 |
| Total, serious adverse events | Part A: Sage-217 High-dose Cohort | 18 | 513 |
| Total, serious adverse events | Part A: Sage-217 Low-dose Cohort | 19 | 645 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38153320 | 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 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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