Major Depressive DisorderNCT06009003
Individual Patient Esmethadone (REL-1017) Expanded Access Program
A study testing REL-1017 in people with Major Depressive Disorder and Depression, run by Relmada Therapeutics, Inc..
Trial summary
To provide expanded access of esmethadone (REL-1017) to patients with a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (REL-1017) who do not have access to other effective therapy and are not eligible for other clinical trials with esmethadone (REL-1017). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Major Depressive Disorder, Depression
- What is being tested?
- REL-1017
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
To provide expanded access of esmethadone (REL-1017) to patients with a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (REL-1017) who do not have access to other effective therapy and are not eligible for other clinical trials with esmethadone (REL-1017).
Read the detailed description
The Expanded Access Program (EAP) is intended to provide pre-approval access to esmethadone (REL-1017) for eligible patients who suffer from a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (REL-1017) as determined by the treating physician and have no satisfactory treatment options. This program is open in the United States and operates under the Individual Patient (also referred to as Single Patient) IND expanded access route in which the patient's treating physician serves as the sponsor. Expanded access requests must be from the patient's treating physicians and submitted according to the Relmada EAP policy at https://www.relmada.com/our-portfolio/eap.
- Conditions
- Major Depressive Disorder, Depression
- Being tested
- REL-1017
- Keywords
- REL-1017, esmethadone, Relmada, antidepressant, NMDA receptor antagonist, Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REL-1017Drug
Also called esmethadone
REL-1017 tablet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Relmada Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sponsor-Investigator
- Responsible party
- Sponsor
- Investigators
- Marco Pappagallo, MD, Study director, Relmada Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009003
- Sponsor's protocol ID
- REL-1017-EAP
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Patient Esmethadone (REL-1017) Expanded Access Program
- ClinicalTrials.gov ID
- NCT06009003
- Acronym / sponsor ID
- REL-1017-EAP
- Conditions
- Major Depressive Disorder, Depression
- Keywords
- REL-1017, esmethadone, Relmada, antidepressant, NMDA receptor antagonist, Depression
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Relmada Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Sponsor-Investigator
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To provide expanded access of esmethadone (REL-1017) to patients with a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (REL-1017) who do not have access to other effective therapy and are not eligible for other clinical trials with esmethadone (REL-1017).
Detailed description
The Expanded Access Program (EAP) is intended to provide pre-approval access to esmethadone (REL-1017) for eligible patients who suffer from a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (REL-1017) as determined by the treating physician and have no satisfactory treatment options. This program is open in the United States and operates under the Individual Patient (also referred to as Single Patient) IND expanded access route in which the patient's treating physician serves as the sponsor. Expanded access requests must be from the patient's treating physicians and submitted according to the Relmada EAP policy at https://www.relmada.com/our-portfolio/eap.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REL-1017Also: esmethadoneREL-1017 tablet | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Pappagallo, MD study director
Relmada Therapeutics
Questions about this trial
What is this clinical trial studying?
A study testing REL-1017 in people with Major Depressive Disorder and Depression, run by Relmada Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.