Phase 3
N=440
A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder
Depressive Disorder, Major
Bottom Line
View on ClinicalTrials.gov: NCT04476030 ↗Enrolled (actual)
440
Serious AEs
0.5%
Results posted
Nov 2023
Primary outcome: Primary: Change From Baseline in the HAMD-17 Total Score at Day 3 — -7.0; -8.9 score on a scale — p=0.0004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SAGE-217 (Drug); Matching Placebo (Drug); Sertraline (Drug); Escitalopram (Drug); Citalopram (Drug); Duloxetine (Drug); Desvenlafaxine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the HAMD-17 Total Score at Day 3 |
-7.0; -8.9 | 0.0004 sig |
| SECONDARY Change From Baseline in the HAMD-17 Total Score Over the Double-Blind Treatment Period |
-10.1; -11.7 | 0.0054 sig |
| SECONDARY Change From Baseline in the HAMD-17 Total Score at Days 15 and 42 |
-12.9; -13.7; -14.9; -14.9 | 0.2477 |
| SECONDARY Change From Baseline in the HAMD-17 Total Score Around End of Blinded Treatment |
-12.7; -13.2 | 0.4458 |
| SECONDARY Percentage of Participants With HAMD-17 Response at Day 15 and Day 42 |
49.2; 53.4; 65.3; 59.9 | 0.4946 |
| SECONDARY Percentage of Participants With HAMD-17 Remission at Day 15 and Day 42 |
21.8; 29.1; 39.2; 37.9 | 0.1417 |
| SECONDARY Change From Baseline in CGI-S Score at Day 15 |
-1.7; -1.9 | 0.1993 |
| SECONDARY Percentage of Participants With CGI-I Response, at Day 3 and Day 15 |
12.9; 22.9; 54.3; 56.6 | 0.0079 sig |
| SECONDARY Change From Baseline in MADRS Total Score at Day 15 |
-15.9; -17.2 | 0.2322 |
| SECONDARY Percentage of Participants With MADRS Response at Day 15 |
48.2; 51.6 | 0.5439 |
| SECONDARY Percentage of Participants With MADRS Remission at Day 15 |
28.4; 30.9 | 0.7054 |
| SECONDARY Change From Baseline in HAM-A Total Score at Day 15 |
-9.0; -9.5 | 0.4188 |
| SECONDARY Time to First HAMD-17 Response |
15; 13 | — |
| SECONDARY Change From Baseline in Depressive Symptoms at Day 15, as Assessed by PHQ-9 |
-8.7; -8.9 | 0.7758 |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
65.6; 74.1 | — |
| SECONDARY Percentage of Participants With TEAEs, Graded by Severity |
38.1; 35.8; 25.2; 34.4; 2.3; 3.8 | — |
Summary
The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Clinical Trials Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period
- 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score of ≥24 at Screening and Day 1
- Participant 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 is willing, able, and eligible to take at least 1 of the 5 ADTs specified in the protocol (an eligible ADT is an ADT that has not been taken during the current depressive episode and for which the participant has no contraindications; further, a participant is not eligible for citalopram if escitalopram has been taken during the current depressive episode, and vice versa)
Exclusion Criteria
- Has attempted suicide associated with the current episode of MDD
- Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant has presented for screening during the 6-month postpartum period
- Participant has treatment-resistant depression
- History of bipolar disorder, schizophrenia, and/or schizoaffective disorder
- Known allergy to SAGE-217, allopregnanolone, or related compounds
- Has taken antidepressants within 30 days prior to Day 1, and/or has taken fluoxetine within 60 days prior to Day 1
Data sourced from ClinicalTrials.gov (NCT04476030). 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.