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

Relmada Therapeutics

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: REL-1017; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04688164

REL-1017-301

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 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.

Enrollment: 227 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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227 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 in addition to their ongoing antidepressant.

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 in addition to their ongoing antidepressant.

Treatment:

Drug: Placebo