A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressiv… (NCT04855747) | Clinical Trial Compass
TerminatedPhase 3
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Stopped: Study REL-1017-302 was terminated early by the Sponsor following the prespecified interim analysis for sample size re-estimation at approximately 75% enrollment of the planned sample size (N=280). Safety data were collected.
United States236 participantsStarted 2021-03-30
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it was stopped, and does that affect whether REL-1017 might still be a viable option for me?
2Since this was a Phase 3 trial testing REL-1017 as an add-on to existing antidepressants, what does the available safety and efficacy data suggest about combining it with the medications I'm already taking?
3The trial was measuring depression symptom changes over 28 days using the MADRS scale — is that short timeframe enough to know whether this kind of treatment would realistically help someone in my situation long-term?
4Given that this trial is no longer recruiting, are there other active trials or approved adjunctive treatments for major depressive disorder that you think would be worth considering instead?
5REL-1017 is an NMDA receptor antagonist similar in mechanism to some existing treatments — based on what was learned from this trial before it was terminated, would you consider this approach appropriate to explore for my specific case?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline to Day 28 in MADRS Total Score