A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
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.
Timeline
- Start
- 2021-03-30
- Primary completion
- 2024-12-31
- Completion
- 2025-01-14
Outcome
Missed primary endpoint
Stopped (Enrollment): “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.”
release “the Reliance II Phase 3 study is futile and is unlikely to meet the primary efficacy endpoint with statistical significance” relmada.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esmethadone | Small molecule | 25 mg | Oral |