Phase 3 N=232 Randomized Quadruple-blind Treatment

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

Major Depressive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT05081167 ↗

Enrolled (actual)

232

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcome: Primary: Change in the MADRS10 Total Score From Baseline to Day 28 — -14.8; -13.9 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: Sep 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the MADRS10 Total Score From Baseline to Day 28	-14.8; -13.9	—
SECONDARY MADRS10 Remission Rate (Total Score ≤10) at Day 28	21.6; 16.4	—
SECONDARY MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28	38.8; 34.5	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05081167). 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.