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

Relmada Therapeutics

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: REL-1017

Study type: Interventional

Funder types: Industry

Identifiers

NCT05081167

REL-1017-303

Details and patient eligibility

About

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.

Enrollment: 232 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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232 participants in 2 patient groups, including a placebo group

REL-1017

Experimental group

Description:

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.

Treatment:

Drug: REL-1017

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo