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

NCT06011577 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: REL-1017-304
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 36

Brief Summary

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

Conditions

Major Depressive Disorder; Depression

Keywords

REL-1017; esmethadone; Relmada; antidepressant; adjunctive; NMDA receptor antagonist; Relight; Depression

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Day 28 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

  Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is calculated as the sum of 10 items, each scored from 0 to 6, resulting in a total score range of 0 to 60. Lower scores indicate less severe depressive symptoms and a better outcome, whereas higher scores indicate more severe depressive symptoms and a worse outcome. The outcome measure reports the change in MADRS total score from Baseline to Day 28. Change was calculated as Day 28 score minus Baseline score.

  Baseline and Day 28

Secondary Outcomes (1)

• Change From Baseline to Day 7 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

  Baseline and Day 7

Study Arms (2)

REL-1017 25 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

REL-1017 DRUG

REL-1017 tablet

Also known as: esmethadone

REL-1017 25 mg

Placebo DRUG

Placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Levomecor Inc.: lead

Study Sites (36)

Relmada Site

Dothan, Alabama, 36303, United States

Location

Relmada Site

Homewood, Alabama, 35209, United States

Location

Relmada Site

Anaheim, California, 92805, United States

Location

Relmada Site

Lafayette, California, 94549, United States

Location

Relmada Site

Newport Beach, California, 92660, United States

Location

Relmada Site

Orange, California, 92868, United States

Location

Relmada Site

Redlands, California, 92374, United States

Location

Relmada Site

Sherman Oaks, California, 91403, United States

Location

Relmada Site

Farmington, Connecticut, 06030, United States

Location

Relmada Site

Brandon, Florida, 33511, United States

Location

Relmada Site

Hialeah, Florida, 33027, United States

Location

Relmada Site

Jacksonville, Florida, 32256, United States

Location

Relmada Site

Miami, Florida, 33133, United States

Location

Relmada Site

Miami, Florida, 33174, United States

Location

Relmada Site

Okeechobee, Florida, 34972, United States

Location

Relmada Site

Tampa, Florida, 33607, United States

Location

Relmada Site

Springfield, Illinois, 62794, United States

Location

Relmada Site

Baltimore, Maryland, 21208, United States

Location

Relmada Site

Mankato, Minnesota, 56001, United States

Location

Relmada Site

Toms River, New Jersey, 08755, United States

Location

Relmada Site

Brooklyn, New York, 11235, United States

Location

Relmada Site

Cedarhurst, New York, 11516, United States

Location

Relmada Site

New York, New York, 10036, United States

Location

Relmada Site

Philadelphia, Pennsylvania, 19104, United States

Location

Relmada Site

Franklin, Tennessee, 37067, United States

Location

Relmada Site

Memphis, Tennessee, 38119, United States

Location

Relmada Site

Austin, Texas, 78712, United States

Location

Relmada Site

Bellaire, Texas, 77401, United States

Location

Relmada Site

Friendswood, Texas, 77546, United States

Location

Relmada Site

Houston, Texas, 77030, United States

Location

Relmada Site

Wichita Falls, Texas, 76309, United States

Location

Relmada Site

Clinton, Utah, 84015, United States

Location

Relmada Site

Draper, Utah, 84020, United States

Location

Relmada Site

Rutland, Vermont, 05701, United States

Location

Relmada Site

Charlottesville, Virginia, 22903, United States

Location

Relmada Site

Seattle, Washington, 98104, United States

Location

Related Links

• Study Homepage

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

Study REL-1017-304 was terminated early by the Sponsor following the prespecified interim analysis for sample size re-estimation conducted in study REL-1017-302. Safety assessments were performed in both studies in accordance with the study protocols.

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Levomecor Inc.

administration@levomecor.com

+16462843119

Study Officials

• Paul Greene, PhD

  Relmada Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: August 17, 2023
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: July 10, 2026
• Results First Posted: July 10, 2026

Record last verified: 2026-06

Locations

US (36)