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

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: REL-1017; Drug: Placebo

• Registration Number: NCT05081167
• Lead Sponsor: Relmada Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-02
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-18
• Primary Completion: 2022-09-13
• Study Completion: 2022-09-14
• Results First Submitted: 2024-02-16
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Results First Posted: 2024-03-26
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REL-1017	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in the MADRS10 Total Score From Baseline to Day 28	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 Outcome Measures

Name	Time	Method
MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28	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
MADRS10 Remission Rate (Total Score ≤10) at Day 28	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.

Trial Locations

Locations (1)

Relmada Site; 🇺🇸 Austin, Texas, United States