drugset / Trial / NCT05081167
A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2021-06-02
- Primary completion
- 2022-09-13
- Completion
- 2022-09-14
Outcome
Missed primary endpoint
release “RELIANCE III study (REL-1017-303), evaluating REL-1017 in the monotherapy setting for Major Depressive Disorder (MDD), did not achieve its primary endpoint” relmada.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esmethadone | Small molecule | 25 mg | — |