Major Depressive DisorderPhase 3RELIGHTNCT06011577
Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD
A Phase 3 study testing REL-1017 in people with Major Depressive Disorder and Depression, run by Levomecor Inc. at 36 sites in United States.
Trial summary
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Depression
- What is being tested?
- REL-1017
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 36 sitesUnited States
- Study dates
- 17 Aug 2023to 19 Dec 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE.
Who cannot join
- Psychiatric hospitalization during the current major depressive episode.
- History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
- Participants who, in the Investigator's judgment, are at significant risk for suicide.
- Pregnant or planning to become pregnant.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Relmada Site
Anaheim, California, 92805
Relmada Site
Austin, Texas, 78712
Relmada Site
Baltimore, Maryland, 21208
Relmada Site
Bellaire, Texas, 77401
Relmada Site
Brandon, Florida, 33511
Relmada Site
Brooklyn, New York, 11235
Relmada Site
Cedarhurst, New York, 11516
Relmada Site
Charlottesville, Virginia, 22903
Relmada Site
Clinton, Utah, 84015
Relmada Site
Dothan, Alabama, 36303
Relmada Site
Draper, Utah, 84020
Relmada Site
Farmington, Connecticut, 06030
Relmada Site
Franklin, Tennessee, 37067
Relmada Site
Friendswood, Texas, 77546
Relmada Site
Hialeah, Florida, 33027
Relmada Site
Homewood, Alabama, 35209
Relmada Site
Houston, Texas, 77030
Relmada Site
Jacksonville, Florida, 32256
Relmada Site
Lafayette, California, 94549
Relmada Site
Mankato, Minnesota, 56001
Relmada Site
Memphis, Tennessee, 38119
Relmada Site
Miami, Florida, 33133
Relmada Site
Miami, Florida, 33174
Relmada Site
New York, New York, 10036
Relmada Site
Newport Beach, California, 92660
Relmada Site
Okeechobee, Florida, 34972
Relmada Site
Orange, California, 92868
Relmada Site
Philadelphia, Pennsylvania, 19104
Relmada Site
Redlands, California, 92374
Relmada Site
Rutland, Vermont, 05701
Relmada Site
Seattle, Washington, 98104
Relmada Site
Sherman Oaks, California, 91403
Relmada Site
Springfield, Illinois, 62794
Relmada Site
Tampa, Florida, 33607
Relmada Site
Toms River, New Jersey, 08755
Relmada Site
Wichita Falls, Texas, 76309
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as an Adjunctive Treatment for Major Depressive Disorder (RELIGHT)
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).
Read the detailed description
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 in patients with inadequate response to ongoing background antidepressant treatment. Eligible patients will continue to take their background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017 or placebo for a 4 week treatment period.
- Conditions
- Major Depressive Disorder, Depression
- Being tested
- REL-1017, Placebo
- Keywords
- REL-1017, esmethadone, Relmada, antidepressant, adjunctive, NMDA receptor antagonist, Relight, 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
PlaceboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Day 28 in Montgomery-Åsberg Depression Rating Scale (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.
Measured: Baseline and Day 28
Secondary outcomes (1)
Change From Baseline to Day 7 in Montgomery-Åsberg Depression Rating Scale (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 7.Change was calculated as Day 7 score minus Baseline score.
Measured: Baseline and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start17 Aug 2023
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Why it stopped: Study REL-1017-304 was terminated early by the Sponsor following the prespecified interim analysis for sample size re-estimation conducted in study REL-1017-302. Safety assessments were performed in both studies in accordance with the study protocols
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Levomecor Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Greene, PhD, Study director, Relmada Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011577
- Sponsor's protocol ID
- REL-1017-304
- Acronym
- RELIGHT
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2023
- Last updated
- 10 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as an Adjunctive Treatment for Major Depressive Disorder (RELIGHT)
- ClinicalTrials.gov ID
- NCT06011577
- Acronym / sponsor ID
- RELIGHT / REL-1017-304
- Conditions
- Major Depressive Disorder, Depression
- Keywords
- REL-1017, esmethadone, Relmada, antidepressant, adjunctive, NMDA receptor antagonist, Relight, Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study REL-1017-304 was terminated early by the Sponsor following the prespecified interim analysis for sample size re-estimation conducted in study REL-1017-302. Safety assessments were performed in both studies in accordance with the study protocols
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Levomecor Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Posted 10 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).
Detailed description
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 in patients with inadequate response to ongoing background antidepressant treatment. Eligible patients will continue to take their background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017 or placebo for a 4 week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REL-1017 25 mg | Experimental | Drug: REL-1017During 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) |
| Placebo | Placebo comparator | Drug: PlaceboDuring the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day in addition to their ongoing antidepressant (ADT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE.
Key exclusion criteria (4 listed)
- Psychiatric hospitalization during the current major depressive episode.
- History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
- Participants who, in the Investigator's judgment, are at significant risk for suicide.
- Pregnant or planning to become pregnant.
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 | REL-1017 25 mg |
| PlaceboPlacebo tablet | Drug | Placebo |
Primary outcome
Change From Baseline to Day 28 in Montgomery-Åsberg Depression Rating Scale (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.
1 secondary outcome
Change From Baseline to Day 7 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline and Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study HomepageLink provided by the sponsor.
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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.
Paul Greene, PhD study director
Relmada Therapeutics
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing REL-1017 in people with Major Depressive Disorder and Depression, run by Levomecor Inc. at 36 sites in United States.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Change From Baseline to Day 28 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline and Day 28). It is what the study was designed to measure, not a finding.
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 10 Jul 2026.