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

June 15, 2026 updated by: Levomecor Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Relmada Site
    • Arizona
      • Chandler, Arizona, United States, 85226
        • Relmada Site
      • Chandler, Arizona, United States, 85286
        • Relmada Site
      • Phoenix, Arizona, United States, 85016
        • Relmada Site
      • Tucson, Arizona, United States, 85704
        • Relmada Site
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Relmada Site
    • California
      • Anaheim, California, United States, 92805
        • Relmada Site
      • Bellflower, California, United States, 90706
        • Relmada Site
      • Encino, California, United States, 91316
        • Relmada Site
      • Lafayette, California, United States, 94549
        • Relmada Site
      • Los Angeles, California, United States, 90015
        • Relmada Site
      • Newport Beach, California, United States, 92660
        • Relmada Site
      • Orange, California, United States, 92868
        • Relmada Site
      • Redlands, California, United States, 92374
        • Relmada Site
      • Santa Ana, California, United States, 92705
        • Relmada Site
      • Stanford, California, United States, 94305
        • Relmada Site
      • Temecula, California, United States, 92591
        • Relmada Site
      • Upland, California, United States, 91786
        • Relmada Site
    • Colorado
      • Denver, Colorado, United States, 80209
        • Relmada Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Relmada Site
      • Hialeah, Florida, United States, 33015
        • Relmada Site
      • Jacksonville, Florida, United States, 32256
        • Relmada Site
      • Maitland, Florida, United States, 32751
        • Relmada Site
      • Miami, Florida, United States, 33133
        • Relmada Site
      • Miami, Florida, United States, 33174
        • Relmada Site
      • Miami, Florida, United States, 33122
        • Relmada Site
      • Miami, Florida, United States, 33125
        • Relmada Site
      • Miami, Florida, United States, 33136
        • Relmada Site
      • Miami Springs, Florida, United States, 33166
        • Relmada Site
      • Okeechobee, Florida, United States, 34972
        • Relmada Site
      • Tampa, Florida, United States, 33607
        • Relmada Site
      • West Palm Beach, Florida, United States, 33407
        • Relmada Site
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Relmada Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Relmada Site
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Relmada Site
      • Chicago, Illinois, United States, 60611
        • Relmada Site
      • Elgin, Illinois, United States, 60123
        • Relmada Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Relmada Site
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Relmada Site
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Relmada Site
      • Bel Air, Maryland, United States, 21015
        • Relmada Site
      • Gaithersburg, Maryland, United States, 20877
        • Relmada Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Relmada Site
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
        • Relmada Site
    • Minnesota
      • Mankato, Minnesota, United States, 56001
        • Relmada Site
    • Missouri
      • Weldon Spring, Missouri, United States, 63304
        • Relmada Site
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Relmada Site
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Relmada Site
    • New York
      • Cedarhurst, New York, United States, 11516
        • Relmada Site
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Relmada Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Relmada Site
      • Cincinnati, Ohio, United States, 45215
        • Relmada Site
      • Cincinnati, Ohio, United States, 45219
        • Relmada Site
      • Westlake, Ohio, United States, 44145
        • Relmada Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Relmada Site
      • State College, Pennsylvania, United States, 16801
        • Relmada Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Relmada Site
    • Texas
      • Austin, Texas, United States, 78737
        • Relmada Site
      • Austin, Texas, United States, 78759
        • Relmada Site
      • Beaumont, Texas, United States, 77702
        • Relmada Site
      • Bellaire, Texas, United States, 77401
        • Relmada Site
      • Dallas, Texas, United States, 75243
        • Relmada Site
      • Friendswood, Texas, United States, 77546
        • Relmada Site
      • Houston, Texas, United States, 77081
        • Relmada Site
      • Sherman, Texas, United States, 75092
        • Relmada Site
      • Wichita Falls, Texas, United States, 76309
        • Relmada Site
    • Utah
      • Draper, Utah, United States, 84020
        • Relmada Site
    • Vermont
      • Rutland, Vermont, United States, 05701
        • Relmada Site
    • Virginia
      • Portsmouth, Virginia, United States, 23703
        • Relmada Site
    • Washington
      • Everett, Washington, United States, 98201
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion 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.

Exclusion Criteria:

  • 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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Day 28 in MADRS Total Score
Time Frame: Baseline and Day 28
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Day 7 in MADRS Total Score
Time Frame: Day 7
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 7. Change was calculated as Day 7 score minus Baseline score.
Day 7
Change From Baseline to Day 28 in Clinical Global Impression-Severity (CGI-S) Score
Time Frame: Day 28
Clinical Global Impression-Severity (CGI-S) is a clinician-rated assessment of illness severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Lower scores indicate less severe illness and a better outcome, whereas higher scores indicate more severe illness and a worse outcome. The outcome measure reports the change in CGI-S score from Baseline to Day 28. Change was calculated as Day 28 score minus Baseline score
Day 28
MADRS10 Remission Rate at Day 28
Time Frame: Day 28
Remission was defined as a Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score ≤10 at Day 28. The MADRS total score ranges from 0 to 60, with lower scores indicating less severe depressive symptoms and a better outcome.
Day 28
MADRS10 Response Rate at Day 28
Time Frame: Day 28
Response was defined as a ≥50% reduction from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. The MADRS total score ranges from 0 to 60, with lower scores indicating less severe depressive symptoms and a better outcome.
Day 28

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Levomecor Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Paul Greene, PhD, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REL-1017-302

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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