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Depression drug trial halted: what happened?

NCT ID NCT04855747

Symptom relief Sponsor: Levomecor Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tested a new drug called REL-1017 (esmethadone) as an add-on treatment for people with major depression who weren't helped enough by their current antidepressant. The trial was a Phase 3, double-blind, placebo-controlled study with 236 participants. However, the study was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
REL-1017 (esmethadone)
What this could lead to
If successful, this could provide a new add-on option for people with major depression who haven't responded well to standard antidepressants.
What could go wrong
The trial was terminated early, so results are limited. It's unclear if REL-1017 is effective or safe as an add-on treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

236 people

The number who actually took part.

Started

Mar 2021

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression Major depressive disorder

Contacts and locations

Locations

  • Relmada Site

    Homewood, Alabama, 35209, United States

  • Relmada Site

    Chandler, Arizona, 85226, United States

  • Relmada Site

    Chandler, Arizona, 85286, United States

  • Relmada Site

    Phoenix, Arizona, 85016, United States

  • Relmada Site

    Tucson, Arizona, 85704, United States

  • Relmada Site

    Bryant, Arkansas, 72022, United States

  • Relmada Site

    Anaheim, California, 92805, United States

  • Relmada Site

    Bellflower, California, 90706, United States

  • Relmada Site

    Encino, California, 91316, United States

  • Relmada Site

    Lafayette, California, 94549, United States

  • Relmada Site

    Los Angeles, California, 90015, United States

  • Relmada Site

    Newport Beach, California, 92660, United States

  • Relmada Site

    Orange, California, 92868, United States

  • Relmada Site

    Redlands, California, 92374, United States

  • Relmada Site

    Santa Ana, California, 92705, United States

  • Relmada Site

    Stanford, California, 94305, United States

  • Relmada Site

    Temecula, California, 92591, United States

  • Relmada Site

    Upland, California, 91786, United States

  • Relmada Site

    Denver, Colorado, 80209, United States

  • Relmada Site

    Brandon, Florida, 33511, United States

  • Relmada Site

    Hialeah, Florida, 33015, United States

  • Relmada Site

    Jacksonville, Florida, 32256, United States

  • Relmada Site

    Maitland, Florida, 32751, United States

  • Relmada Site

    Miami, Florida, 33122, United States

  • Relmada Site

    Miami, Florida, 33125, United States

  • Relmada Site

    Miami, Florida, 33133, United States

  • Relmada Site

    Miami, Florida, 33136, United States

  • Relmada Site

    Miami, Florida, 33174, United States

  • Relmada Site

    Miami Springs, Florida, 33166, United States

  • Relmada Site

    Okeechobee, Florida, 34972, United States

  • Relmada Site

    Tampa, Florida, 33607, United States

  • Relmada Site

    West Palm Beach, Florida, 33407, United States

  • Relmada Site

    Savannah, Georgia, 31406, United States

  • Relmada Site

    Boise, Idaho, 83704, United States

  • Relmada Site

    Chicago, Illinois, 60611, United States

  • Relmada Site

    Chicago, Illinois, 60634, United States

  • Relmada Site

    Elgin, Illinois, 60123, United States

  • Relmada Site

    Overland Park, Kansas, 66210, United States

  • Relmada Site

    Marrero, Louisiana, 70072, United States

  • Relmada Site

    Baltimore, Maryland, 21208, United States

  • Relmada Site

    Bel Air, Maryland, 21015, United States

  • Relmada Site

    Gaithersburg, Maryland, 20877, United States

  • Relmada Site

    Boston, Massachusetts, 02131, United States

  • Relmada Site

    Bloomfield Hills, Michigan, 48302, United States

  • Relmada Site

    Mankato, Minnesota, 56001, United States

  • Relmada Site

    Weldon Spring, Missouri, 63304, United States

  • Relmada Site

    Las Vegas, Nevada, 89121, United States

  • Relmada Site

    Toms River, New Jersey, 08755, United States

  • Relmada Site

    Cedarhurst, New York, 11516, United States

  • Relmada Site

    Monroe, North Carolina, 28112, United States

  • Relmada Site

    Beachwood, Ohio, 44122, United States

  • Relmada Site

    Cincinnati, Ohio, 45215, United States

  • Relmada Site

    Cincinnati, Ohio, 45219, United States

  • Relmada Site

    Westlake, Ohio, 44145, United States

  • Relmada Site

    Philadelphia, Pennsylvania, 19104, United States

  • Relmada Site

    State College, Pennsylvania, 16801, United States

  • Relmada Site

    Memphis, Tennessee, 38119, United States

  • Relmada Site

    Austin, Texas, 78737, United States

  • Relmada Site

    Austin, Texas, 78759, United States

  • Relmada Site

    Beaumont, Texas, 77702, United States

  • Relmada Site

    Bellaire, Texas, 77401, United States

  • Relmada Site

    Dallas, Texas, 75243, United States

  • Relmada Site

    Friendswood, Texas, 77546, United States

  • Relmada Site

    Houston, Texas, 77081, United States

  • Relmada Site

    Sherman, Texas, 75092, United States

  • Relmada Site

    Wichita Falls, Texas, 76309, United States

  • Relmada Site

    Draper, Utah, 84020, United States

  • Relmada Site

    Rutland, Vermont, 05701, United States

  • Relmada Site

    Portsmouth, Virginia, 23703, United States

  • Relmada Site

    Everett, Washington, 98201, United States

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