A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)

Relmada Therapeutics, Inc.232 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

232

Conditions

Major Depressive Disorder

Interventions

REL-1017DRUG

REL-1017 tablet

PlaceboDRUG

Placebo tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (10)

Relmada Site

Maitland, Florida, United States

Relmada Site

Miami, Florida, United States

Relmada Site

Miami, Florida, United States

Relmada Site

Miami Springs, Florida, United States

Outcomes

Primary Outcomes

Change in the MADRS10 Total Score From Baseline to 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.

Time frame: Day 28

Secondary Outcomes

MADRS10 Remission Rate (Total Score ≤10) at Day 28

Therapeutic remission rate with REL-1017 as adjunctive treatment versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). Remission is defined as MADRS10 Total Score ≤10 at Day 28. A higher percentage of remission indicates a higher percentage of subjects with MADRS10 Total Score ≤10 at Day 28.

Time frame: Day 28

MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28

Therapeutic response to REL-1017 as adjunctive treatment versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). Response rate is defined as an improvement ≥50% compared with total Baseline MADRS10 score

Time frame: Day 28

Data from ClinicalTrials.gov

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