Phase 3
N=227
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04688164 ↗Enrolled (actual)
227
Serious AEs
1.3%
Results posted
Mar 2024
Primary outcome: Primary: Change in the MADRS10 Total Score From Baseline to Day 28 — -15.1; -12.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- REL-1017 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Relmada Therapeutics, Inc.
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the MADRS10 Total Score From Baseline to Day 28 |
-15.1; -12.9 | — |
| SECONDARY MADRS10 Remission Rate (Total Score ≤10) at Day 28 |
22.1; 13.2 | — |
| SECONDARY MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28 |
39.8; 27.2 | — |
Summary
This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder. Study participants will continue to take their current antidepressant therapy in addition to the study drug or placebo for the duration of the treatment period.
Eligibility Criteria
Inclusion Criteria
- Adults 18 to 65 years, inclusive.
- Diagnosed with Major Depressive Disorder (MDD) based on structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD.
- Current major depressive episode.
- With inadequate response to 1-3 first-line antidepressants administered at an adequate and stable dose
Exclusion Criteria
- Any current and primary psychiatric disorder other than Major Depressive Disorder.
- Severe alcohol or substance use disorder.
- History of bipolar I and II disorder, psychosis, and/or mania.
- Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
- Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time.
Data sourced from ClinicalTrials.gov (NCT04688164). 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.