A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder (The RELIANCE-I Study)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Relmada Therapeutics, Inc.
- Enrollment
- 227
- Locations
- 1
- Primary Endpoint
- Change in the MADRS10 Total Score From Baseline to Day 28
Study 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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 in addition to their ongoing antidepressant.
Intervention: REL-1017 (Drug)
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 in addition to their ongoing antidepressant.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in the MADRS10 Total Score From Baseline to Day 28
Time Frame: Day 28
Therapeutic efficacy of REL-1017 as adjunctive treatment 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)