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

February 15, 2024 updated by: Relmada Therapeutics, Inc.

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

A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Recruiting
        • Relmada Site
      • Homewood, Alabama, United States, 35209
        • Not yet recruiting
        • Relmada Site
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Active, not recruiting
        • Relmada Site
    • California
      • Anaheim, California, United States, 92805
        • Not yet recruiting
        • Relmada Site
      • Culver City, California, United States, 90230
        • Active, not recruiting
        • Relmada Site
      • Lafayette, California, United States, 94549
        • Active, not recruiting
        • Relmada Site
      • Newport Beach, California, United States, 92660
        • Active, not recruiting
        • Relmada Site
      • Orange, California, United States, 92868
        • Recruiting
        • Relmada Site
      • Rancho Cucamonga, California, United States, 91730
        • Not yet recruiting
        • Relmada Site
      • Redlands, California, United States, 92374
        • Active, not recruiting
        • Relmada Site
      • Sherman Oaks, California, United States, 91403
        • Recruiting
        • Relmada Site
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Recruiting
        • Relmada Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Relmada Site
      • Hialeah, Florida, United States, 33027
        • Recruiting
        • Relmada Site
      • Jacksonville, Florida, United States, 32256
        • Active, not recruiting
        • Relmada Site
      • Miami, Florida, United States, 33133
        • Active, not recruiting
        • Relmada Site
      • Miami, Florida, United States, 33174
        • Active, not recruiting
        • Relmada Site
      • Okeechobee, Florida, United States, 34972
        • Active, not recruiting
        • Relmada Site
      • Tampa, Florida, United States, 33607
        • Active, not recruiting
        • Relmada Site
      • Tampa, Florida, United States, 33614
        • Active, not recruiting
        • Relmada Site
    • Illinois
      • Chicago, Illinois, United States, 60604
        • Active, not recruiting
        • Relmada Site
      • Springfield, Illinois, United States, 62794
        • Recruiting
        • Relmada Site
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Active, not recruiting
        • Relmada Site
    • Minnesota
      • Mankato, Minnesota, United States, 56001
        • Not yet recruiting
        • Relmada Site
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Active, not recruiting
        • Relmada Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Not yet recruiting
        • Relmada Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Recruiting
        • Relmada Site
      • Cedarhurst, New York, United States, 11516
        • Active, not recruiting
        • Relmada Site
      • New York, New York, United States, 10036
        • Recruiting
        • Relmada Site
    • Ohio
      • West Chester, Ohio, United States, 45069
        • Active, not recruiting
        • Relmada Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • Relmada Site
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Relmada Site
      • Memphis, Tennessee, United States, 38119
        • Active, not recruiting
        • Relmada Site
    • Texas
      • Austin, Texas, United States, 78712
        • Not yet recruiting
        • Relmada Site
      • Bellaire, Texas, United States, 77401
        • Active, not recruiting
        • Relmada Site
      • Friendswood, Texas, United States, 77546
        • Active, not recruiting
        • Relmada Site
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Relmada Site
      • Wichita Falls, Texas, United States, 76309
        • Active, not recruiting
        • Relmada Site
    • Utah
      • Clinton, Utah, United States, 84015
        • Recruiting
        • Relmada Site
      • Draper, Utah, United States, 84020
        • Active, not recruiting
        • Relmada Site
    • Vermont
      • Rutland, Vermont, United States, 05701
        • Not yet recruiting
        • Relmada Site
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • Relmada Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Relmada Site

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REL-1017 25 mg
During the double blind treatment period (28 days), participants will take 1 tablet of REL-1017 25 mg, orally, per day in addition to their ongoing antidepressant (ADT)
Drug: REL-1017
REL-1017 tablet
Other Names:
  • esmethadone
Placebo Comparator: Placebo
During the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day in addition to their ongoing antidepressant (ADT)
Drug: Placebo
Placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in MADRS Total Score From Baseline to Day 28
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Relmada Therapeutics, Inc.

Investigators

  • Study Director: Marco Pappagallo, Relmada Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REL-1017-304

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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