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Could a new drug offer hope for Treatment-Resistant depression?

NCT ID NCT06009003

Disease control Sponsor: Relmada Therapeutics, 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 Results may not be published yet.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
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) This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This program provides access to esmethadone (REL-1017), an experimental drug, for people with serious depression who have not responded to standard treatments and cannot join other clinical trials. The goal is to offer a potential treatment option when no satisfactory alternative exists. Participants receive esmethadone tablets under the supervision of their treating physician.

What this could mean

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

Active substance
esmethadone (REL-1017) tablet
What this could lead to
If successful, this program could provide a treatment option for people with severe depression who have exhausted standard therapies.
What could go wrong
This is an expanded access program, not a controlled trial, so its effectiveness and safety are not systematically evaluated. Esmethadone may have side effects and is not a proven cure.

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.

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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: * Patients who may potentially benefit from treatment with esmethadone (REL-1017) as determined by the treating physician. * Have undergone appropriate standard treatments without success and in the opinion of the treating physician no comparable or satisfactory alternative treatment is available to treat the disease or condition. * Are ineligible or unable to participate in any ongoing clinical study of the investigational product. * Condition for which, in the opinion of the treating physician, there is sufficient evidence of a potential benefit from the use of the investigational product, and that potential benefit outweighs the known or anticipated risks. Exclusion Criteria: * History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant. * History of QTc prolongation. * History of allergy or hypersensitivity to methadone or related drugs. * Pregnant or planning to become pregnant. * Breast-feeding or planning to breast-feed.

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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

More trials for these conditions

Other studies related to the condition(s) this trial covers.