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

NCT04855747 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: REL-1017-302
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 70

Brief Summary

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 Disorder; Depression

Keywords

REL-1017; Relmada; NMDA Receptor Antagonist; Esmethadone; Adjunctive; Antidepressant; Reliance; Depression

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Day 28 in 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 (4)

• Change From Baseline to Day 7 in MADRS Total Score

  Day 7

• Change From Baseline to Day 28 in Clinical Global Impression-Severity (CGI-S) Score

  Day 28

• MADRS10 Remission Rate at Day 28

  Day 28

• MADRS10 Response Rate at Day 28

  Day 28

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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Levomecor Inc.: lead

Study Sites (70)

Relmada Site

Homewood, Alabama, 35209, United States

Location

Relmada Site

Chandler, Arizona, 85226, United States

Location

Relmada Site

Chandler, Arizona, 85286, United States

Location

Relmada Site

Phoenix, Arizona, 85016, United States

Location

Relmada Site

Tucson, Arizona, 85704, United States

Location

Relmada Site

Bryant, Arkansas, 72022, United States

Location

Relmada Site

Anaheim, California, 92805, United States

Location

Relmada Site

Bellflower, California, 90706, United States

Location

Relmada Site

Encino, California, 91316, United States

Location

Relmada Site

Lafayette, California, 94549, United States

Location

Relmada Site

Los Angeles, California, 90015, 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

Santa Ana, California, 92705, United States

Location

Relmada Site

Stanford, California, 94305, United States

Location

Relmada Site

Temecula, California, 92591, United States

Location

Relmada Site

Upland, California, 91786, United States

Location

Relmada Site

Denver, Colorado, 80209, United States

Location

Relmada Site

Brandon, Florida, 33511, United States

Location

Relmada Site

Hialeah, Florida, 33015, United States

Location

Relmada Site

Jacksonville, Florida, 32256, United States

Location

Relmada Site

Maitland, Florida, 32751, United States

Location

Relmada Site

Miami, Florida, 33122, United States

Location

Relmada Site

Miami, Florida, 33125, United States

Location

Relmada Site

Miami, Florida, 33133, United States

Location

Relmada Site

Miami, Florida, 33136, United States

Location

Relmada Site

Miami, Florida, 33174, United States

Location

Relmada Site

Miami Springs, Florida, 33166, United States

Location

Relmada Site

Okeechobee, Florida, 34972, United States

Location

Relmada Site

Tampa, Florida, 33607, United States

Location

Relmada Site

West Palm Beach, Florida, 33407, United States

Location

Relmada Site

Savannah, Georgia, 31406, United States

Location

Relmada Site

Boise, Idaho, 83704, United States

Location

Relmada Site

Chicago, Illinois, 60611, United States

Location

Relmada Site

Chicago, Illinois, 60634, United States

Location

Relmada Site

Elgin, Illinois, 60123, United States

Location

Relmada Site

Overland Park, Kansas, 66210, United States

Location

Relmada Site

Marrero, Louisiana, 70072, United States

Location

Relmada Site

Baltimore, Maryland, 21208, United States

Location

Relmada Site

Bel Air, Maryland, 21015, United States

Location

Relmada Site

Gaithersburg, Maryland, 20877, United States

Location

Relmada Site

Boston, Massachusetts, 02131, United States

Location

Relmada Site

Bloomfield Hills, Michigan, 48302, United States

Location

Relmada Site

Mankato, Minnesota, 56001, United States

Location

Relmada Site

Weldon Spring, Missouri, 63304, United States

Location

Relmada Site

Las Vegas, Nevada, 89121, United States

Location

Relmada Site

Toms River, New Jersey, 08755, United States

Location

Relmada Site

Cedarhurst, New York, 11516, United States

Location

Relmada Site

Monroe, North Carolina, 28112, United States

Location

Relmada Site

Beachwood, Ohio, 44122, United States

Location

Relmada Site

Cincinnati, Ohio, 45215, United States

Location

Relmada Site

Cincinnati, Ohio, 45219, United States

Location

Relmada Site

Westlake, Ohio, 44145, United States

Location

Relmada Site

Philadelphia, Pennsylvania, 19104, United States

Location

Relmada Site

State College, Pennsylvania, 16801, United States

Location

Relmada Site

Memphis, Tennessee, 38119, United States

Location

Relmada Site

Austin, Texas, 78737, United States

Location

Relmada Site

Austin, Texas, 78759, United States

Location

Relmada Site

Beaumont, Texas, 77702, United States

Location

Relmada Site

Bellaire, Texas, 77401, United States

Location

Relmada Site

Dallas, Texas, 75243, United States

Location

Relmada Site

Friendswood, Texas, 77546, United States

Location

Relmada Site

Houston, Texas, 77081, United States

Location

Relmada Site

Sherman, Texas, 75092, United States

Location

Relmada Site

Wichita Falls, Texas, 76309, United States

Location

Relmada Site

Draper, Utah, 84020, United States

Location

Relmada Site

Rutland, Vermont, 05701, United States

Location

Relmada Site

Portsmouth, Virginia, 23703, United States

Location

Relmada Site

Everett, Washington, 98201, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study REL-1017-302 was terminated early by the Sponsor following the prespecified interim analysis for sample size re-estimation at approximately 75% enrollment of the planned sample size (N=280). Safety data were collected.

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

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: March 30, 2021
• Primary Completion: December 31, 2024
• Study Completion: January 14, 2025
• Last Updated: July 10, 2026
• Results First Posted: July 10, 2026

Record last verified: 2026-06

Locations

US (70)