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

Description

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.

Conditions

Major Depressive DisorderDepression
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Related Conditions:

Major Depressive DisorderDepression

Study Overview

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Study Details

Study 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 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.

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder (The RELIANCE-II Study)

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

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Homewood

Relmada Site, Homewood, Alabama, United States, 35209

Chandler

Relmada Site, Chandler, Arizona, United States, 85226

Chandler

Relmada Site, Chandler, Arizona, United States, 85286

Phoenix

Relmada Site, Phoenix, Arizona, United States, 85016

Tucson

Relmada Site, Tucson, Arizona, United States, 85704

Bryant

Relmada Site, Bryant, Arkansas, United States, 72022

Anaheim

Relmada Site, Anaheim, California, United States, 92805

Bellflower

Relmada Site, Bellflower, California, United States, 90706

Encino

Relmada Site, Encino, California, United States, 91316

Lafayette

Relmada Site, Lafayette, California, United States, 94549

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Body mass index (BMI) between 18.0 and 35.0 kg/m2.
  • * Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
  • * Current Major Depressive Episode (MDE).
  • * Treated on approved, stable first-line anti-depressant therapy with inadequate response to 1 to 3 valid courses of treatment with a depressant medication in the current MDE.
  • * 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.
  • * Poorly controlled diabetes as defined by HbA1c \> 7.5%, despite standard care. Subjects with HbA1c \>7.5% may continue in the study if approved by the Relmada Medical Monitor.
  • * Having received ketamine or esketamine within 60 days prior to Screening.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Relmada Therapeutics, Inc.,

Paul Greene, PhD, STUDY_DIRECTOR, Relmada Therapeutics

Study Record Dates

2025-01-14