Phase 3
Completed N=227
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Source: ClinicalTrials.gov NCT04688164 ↗Enrolled (actual)
227
Serious AEs
1.3%
Results posted
Mar 2024
Primary outcomePrimary: Change in the MADRS10 Total Score From Baseline to Day 28 — -15.1; -12.9 score on a scale
◆ Published Evidence
Emerging
16citations · ~8 / year
Efficacy and Safety of Esmethadone (REL-1017) in Patients With Major Depressive Disorder and Inadequate Response to Standard Antidepressants: A Phase 3 Randomized Controlled Trial.
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.
Linked Publications (2)
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Efficacy and Safety of Esmethadone (REL-1017) in Patients With Major Depressive Disorder and Inadequate Response to Standard Antidepressants: A Phase 3 Randomized Controlled Trial.
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Depression severity and efficacy outcomes: post hoc analyses from a phase 3 trial of esmethadone for the adjunctive treatment of major depressive disorder with inadequate response to standard antidepressants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the MADRS10 Total Score From Baseline to Day 28 |
-15.1; -12.9 | — |
| SECONDARY MADRS10 Remission Rate (Total Score ≤10) at Day 28 |
22.1; 13.2 | — |
| SECONDARY MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28 |
39.8; 27.2 | — |
Eligibility Criteria
Inclusion Criteria
- Adults 18 to 65 years, inclusive.
- Diagnosed with Major Depressive Disorder (MDD) based on structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD.
- Current major depressive episode.
- With inadequate response to 1-3 first-line antidepressants administered at an adequate and stable dose
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.
- Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
- Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time.
Data sourced from ClinicalTrials.gov (NCT04688164) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.