Phase 3
Completed N=581
A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder
Major Depressive Disorder
Source: ClinicalTrials.gov NCT03672175 ↗
Enrolled (actual)
581
Serious AEs
0.7%
Results posted
Nov 2022
Primary outcomePrimary: Change From Baseline in the 17-item HAM-D Total Score at Day 15 — -11.1; -11.5; -12.5 score on a scale — p=0.6638
◆ Published Evidence
Established
64citations · ~21 / year
Zuranolone in Major Depressive Disorder: Results From MOUNTAIN-A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial.
Summary
This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants with major depressive disorder (MDD).
Linked Publications
-
Zuranolone in Major Depressive Disorder: Results From MOUNTAIN-A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the 17-item HAM-D Total Score at Day 15 |
-11.1; -11.5; -12.5 | 0.6638 |
| SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 15 |
-1.5; -1.6; -1.7 | 0.6905 |
| SECONDARY Change From Baseline in the 17-item HAM-D Total Score |
-6.7; -7.1; -8.3; -7.8; -8.4; -9.9 | 0.5725 |
| SECONDARY Number of Participants Achieving HAM-D Response |
60; 65; 77; 56; 59; 59 | 0.8903 |
| SECONDARY Number of Participants Achieving HAM-D Remission |
33; 35; 48; 35; 39; 33 | 0.8245 |
| SECONDARY Number of Participants Achieving Clinical Global Impression - Improvement (CGI-I) Response at Day 15 |
65; 71; 84 | 0.8303 |
| SECONDARY Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Day 15 |
-8.7; -9.1; -9.4 | 0.5021 |
| SECONDARY Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 |
-16.0; -16.7; -18.0 | 0.5987 |
| SECONDARY Change From Baseline in HAM-D Core Subscale Score |
-21.7; -21.3; -22.6; -23.1; -22.4; -23.6 | 0.8499 |
| SECONDARY Change From Baseline in HAM-D Anxiety Subscale Score |
-19.4; -20.1; -22.1; -22.0; -20.7; -21.7 | 0.6848 |
| SECONDARY Change From Baseline in HAM-D Bech-6 Subscale Score |
-26.2; -26.3; -28.7; -28.0; -27.4; -28.7 | 0.9591 |
| SECONDARY Change From Baseline in HAM-D Maier Subscale Score |
-23.4; -23.1; -25.9; -25.0; -24.8; -26.2 | 0.8575 |
| SECONDARY Change From Baseline in HAM-D Individual Item Scores |
-1.3; -1.3; -1.4; -1.3; -1.3; -1.5 | 0.6270 |
| SECONDARY Change From Baseline in Insomnia Severity Index (ISI) Total Score |
-6.2; -7.4; -8.2; -6.9; -5.9; -6.9 | 0.1308 |
| SECONDARY Change From Baseline in Core Consensus Sleep Diary Parameters: Sleep Onset Latency (sSL), Wake After Sleep Onset (sWASO), and Total Sleep Time (sTST) |
-12.2; -14.4; -20.1; -12.1; -16.4; -15.8 | 0.6110 |
| SECONDARY Change From Baseline in Core Consensus Sleep Diary Parameter: Number of Awakenings (sNAW) |
-0.4; -0.5; -0.7; -0.5; -0.3; -0.5 | 0.4737 |
| SECONDARY Change From Baseline in Core Consensus Sleep Diary Parameter: Number of Participants With Subjective Sleep Quality (sSQ) Response |
36; 35; 32; 30; 35; 28 | 0.6741 |
| SECONDARY Change From Baseline in the 36-item Short Form Survey Version 2 (SF-36v2) Physical and Mental Component Summary Scores |
-0.9; -1.2; -1.4; -1.9; -2.1; -1.3 | 0.7375 |
| SECONDARY Change From Baseline in the 9-item Patient Health Questionnaire (PHQ-9) Total Score |
-7.1; -7.3; -8.3; -8.1; -7.3; -8.7 | 0.8821 |
| SECONDARY Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) and Serious TEAE in Treatment and FU Periods |
77; 78; 93; 46; 44; 46 | — |
| SECONDARY Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) and Serious TEAE in Extended FU Period |
27; 29; 28; 1; 3; 1 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Laboratory Measures in Treatment and FU Periods |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Laboratory Measures in Extended FU Period |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Vital Sign Abnormalities in Treatment and FU Periods |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Vital Sign Abnormalities in Extended FU Period |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities in Treatment and FU Periods |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant ECG Abnormalities in Extended FU Period |
0; 0; 0 | — |
| SECONDARY Number of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) in Double-blind Treatment Period at Day 42 |
12; 11; 11 | — |
| SECONDARY Number of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) in Extended FU Period at Day 182 |
9; 6; 3 | — |
| SECONDARY Change From Baseline in the 20-item Physician Withdrawal Checklist (PWC-20) Total Score |
-5.407; -5.370; -5.699; -6.128; -5.421; -5.917 | — |
Eligibility Criteria
Inclusion Criteria
- Participant had a diagnosis of MDD with symptoms that had been present for at least a 4-week period.
- Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥32 and a 17-item Hamilton Rating Scale for Depression (HAM-D) total score ≥22 at screening and Day 1 (prior to dosing).
Exclusion Criteria
- Participant had active psychosis.
- Participant had attempted suicide associated with the current episode of MDD.
- Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
Data sourced from ClinicalTrials.gov (NCT03672175) 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.