A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of REL-1017 Monotherapy for Major Depressive Disorder
Overview
- Phase
- Phase 3
- Intervention
- REL-1017
- Conditions
- Major Depressive Disorder
- Sponsor
- Relmada Therapeutics, Inc.
- Enrollment
- 232
- Locations
- 1
- Primary Endpoint
- Change in the MADRS10 Total Score From Baseline to Day 28
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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 a monotherapy for Major Depressive Disorder.
Investigators
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.
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.
Arms & Interventions
REL-1017
A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017.
Intervention: REL-1017
Placebo
Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in the MADRS10 Total Score From Baseline to Day 28
Time Frame: Day 28
Therapeutic efficacy of REL-1017 as monotherapy versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement.
Secondary Outcomes
- MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28(Day 28)
- MADRS10 Remission Rate (Total Score ≤10) at Day 28(Day 28)