Phase 3
Completed N=1,515
A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
Source: ClinicalTrials.gov NCT03864614 ↗Enrolled (actual)
1,515
Serious AEs
3.1%
Results posted
Jul 2024
Primary outcomePrimary: Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 374; 437; 57 Participants
◆ Published Evidence
Emerging
13citations · ~4 / year
Long-Term Safety and Efficacy of Initial and Repeat Treatment Courses With Zuranolone in Adult Patients With Major Depressive Disorder: Interim Results From the Open-Label, Phase 3 SHORELINE Study.
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.
Linked Publications
-
Long-Term Safety and Efficacy of Initial and Repeat Treatment Courses With Zuranolone in Adult Patients With Major Depressive Disorder: Interim Results From the Open-Label, Phase 3 SHORELINE Study.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.