Phase 3
Completed N=232
A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
Source: ClinicalTrials.gov NCT05081167 ↗Enrolled (actual)
232
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Change in the MADRS10 Total Score From Baseline to Day 28 — -14.8; -13.9 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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 a monotherapy for Major Depressive Disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the MADRS10 Total Score From Baseline to Day 28 |
-14.8; -13.9 | — |
| SECONDARY MADRS10 Remission Rate (Total Score ≤10) at Day 28 |
21.6; 16.4 | — |
| SECONDARY MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28 |
38.8; 34.5 | — |
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.
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 (NCT05081167). 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.