Phase 3
N=1,515
A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03864614 ↗Enrolled (actual)
1,515
Serious AEs
3.1%
Results posted
Jul 2024
Primary outcome: Primary: Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 374; 437; 57 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SAGE-217 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
374; 437; 57 | — |
| PRIMARY Part B: Number of Participants With TEAEs |
87 | — |
| 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) |
262; 264; 29; 128; 141; 14 | — |
| PRIMARY Part B: Number of Participants With Suicidal Ideation (SI) and Suicidal Behavior (SB) as Assessed by the C-SSRS |
17; 16; 0; 1; 19; 24 | — |
| SECONDARY Parts A and B: Time to First Repeat Treatment With SAGE-217 |
281; 135; 79; 233 | — |
| SECONDARY Parts A and B: Number of Participants Who Achieved the Requirements for Repeat Treatment for SAGE-217 |
174; 224; 80; 28; 61 | — |
| SECONDARY Parts A and B: Number of Repeat Treatment Cycles of SAGE-217 for Each Participant |
0.8; 0.9; 2.8; 1.6; 1.9 | — |
| SECONDARY Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 in Study Period 1 |
-15.3; -14.6; -20.1 | — |
| SECONDARY Part A: Change From Baseline (CFB) in the HAMD-17 Total Score at Day 15 of Each Treatment Cycle |
-13.3; -12.3; -15.4; -12.2; -12.5; -15.1 | — |
| SECONDARY Part B: Change From Baseline in the HAMD-17 Total Score at Day 15 of Each Treatment (Initial and/or Repeat Treatment) Cycle |
-10.1; -10.7; -9.6; -9.7; -10.8 | — |
| SECONDARY Part A: Percentage of Participants Who Achieved HAM-D Response During Treatment Cycle 1 |
67.3; 65.9; 100 | — |
| SECONDARY Part A: Percentage of Participants Who Achieved HAM-D Response During Each Study Period |
65.3; 62.8; 67.9; 58.0; 59.3; 68.6 | — |
| SECONDARY Part B: Percentage of Participants Who Achieved HAM-D Response |
46.2; 47.1; 38.1; 30.0; 60.0 | — |
| SECONDARY Part A: Percentage of Participants Who Achieved HAM-D Remission During Treatment Cycle 1 |
40.9; 40.2; 40.0 | — |
| SECONDARY Part A: Percentage of Participants Who Achieved HAM-D Remission During Each Study Period |
38.7; 31.9; 37.2; 34.8; 29.6; 32.9 | — |
| SECONDARY Part B: Percentage of Participants Who Achieved HAM-D Remission |
19.2; 29.4; 26.2; 20.0; 40.0 | — |
| SECONDARY Part A: Percentage of Participants Who Achieved Clinical Global Impression - Improvement (CGI-I) Response During Treatment Cycle 1 |
78.9; 75.0; 96.3 | — |
| SECONDARY Part A: Percentage of Participants Who Achieved CGI-I Response During Each Study Period |
76.7; 75.0; 79.5; 65.2; 73.2; 80.9 | — |
| SECONDARY Part B: Percentage of Participants Who Achieved CGI-I Response |
53.8; 63.5; 64.3; 55.0; 60.0 | — |
| SECONDARY Part A: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Treatment Cycle 1 |
-2.3; -2.1; -2.4 | — |
| SECONDARY Part A: Change From Baseline in CGI-S Score During Each Treatment Cycle |
-2.0; -1.9; -2.2; -1.8; -1.8; -2.1 | — |
| SECONDARY Part B: Change From Baseline in CGI-S Score |
-1.5; -1.8; -1.7; -1.4; -1.4 | — |
Summary
This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with SAGE-217 in adult participants with MDD.
Eligibility Criteria
Inclusion Criteria
- Participant has a diagnosis of MDD as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Trial Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period.
- Participant is in good physical health and has no clinically significant findings, as determined by the Investigator, on physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory tests.
- Participant has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥28 and a HAM-D total score of ≥20 at Screening and Day 1 (prior to dosing).
Exclusion Criteria
- Participant has attempted suicide associated with the current episode of MDD.
- Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- Participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.
Data sourced from ClinicalTrials.gov (NCT03864614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.