drugset / Trial / NCT05081167

A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)

NCT05081167 ↗

Phase 3 Completed 232 enrolled Relmada Therapeutics, Inc.
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

EvaluationDrugModalityDoseRoute
Subject Esmethadone Small molecule 25 mg —