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NCT06011577 Clinical Trial

Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD

Depression Clinical Trial

— RELIGHT  

Official title:
A Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as an Adjunctive Treatment for Major Depressive Disorder (RELIGHT)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06011577
Other study ID # REL-1017-304
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 17, 2023
Est. completion date December 2024

Study information
Verified date February 2024
Source Relmada Therapeutics, Inc.
Contact Medical Director
Phone 786-638-7384
Email clinicaltrials@relmada.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with 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 in patients with inadequate response to ongoing background antidepressant treatment. Eligible patients will continue to take their background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017 or placebo for a 4 week treatment period.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Male or female outpatients, 18-65 years of age, inclusive. - Currently meets DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT, with a current major depressive episode (MDE). - Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE. Exclusion Criteria: - Psychiatric hospitalization during the current major depressive episode. - History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant. - Participants who, in the Investigator's judgment, are at significant risk for suicide. - Pregnant or planning to become pregnant. - Breast-feeding or planning to breast-feed.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• REL-1017
REL-1017 tablet
• Placebo
Placebo tablet

Locations
Country Name City State
United States Relmada Site Albuquerque New Mexico
United States Relmada Site Anaheim California
United States Relmada Site Austin Texas
United States Relmada Site Baltimore Maryland
United States Relmada Site Bellaire Texas
United States Relmada Site Brandon Florida
United States Relmada Site Brooklyn New York
United States Relmada Site Bryant Arkansas
United States Relmada Site Cedarhurst New York
United States Relmada Site Charlottesville Virginia
United States Relmada Site Chicago Illinois
United States Relmada Site Clinton Utah
United States Relmada Site Culver City California
United States Relmada Site Dothan Alabama
United States Relmada Site Draper Utah
United States Relmada Site Farmington Connecticut
United States Relmada Site Franklin Tennessee
United States Relmada Site Friendswood Texas
United States Relmada Site Hialeah Florida
United States Relmada Site Homewood Alabama
United States Relmada Site Houston Texas
United States Relmada Site Jacksonville Florida
United States Relmada Site Lafayette California
United States Relmada Site Mankato Minnesota
United States Relmada Site Memphis Tennessee
United States Relmada Site Miami Florida
United States Relmada Site Miami Florida
United States Relmada Site New York New York
United States Relmada Site Newport Beach California
United States Relmada Site Okeechobee Florida
United States Relmada Site Orange California
United States Relmada Site Philadelphia Pennsylvania
United States Relmada Site Rancho Cucamonga California
United States Relmada Site Redlands California
United States Relmada Site Rutland Vermont
United States Relmada Site Seattle Washington
United States Relmada Site Sherman Oaks California
United States Relmada Site Springfield Illinois
United States Relmada Site Tampa Florida
United States Relmada Site Tampa Florida
United States Relmada Site Toms River New Jersey
United States Relmada Site West Chester Ohio
United States Relmada Site Wichita Falls Texas

Sponsors (1)
Lead Sponsor Collaborator
Relmada Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in MADRS Total Score From Baseline to Day 28 The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points. Day 28
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