NCT04688164

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

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder (The RELIANCE-I Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Relmada Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	REL-1017	REL-1017 tablet
DRUG	Placebo	Placebo tablet

Timeline

• Start date: 2021-01-08
• Primary completion: 2022-11-01
• Completion: 2022-11-10
• First posted: 2020-12-29
• Last updated: 2024-08-27
• Results posted: 2024-03-26

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study