Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Relmada Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Male or female outpatients, 18-65 years of age, inclusive.

• Currently meets DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT, with a current major depressive episode (MDE).

• Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE.

Exclusion Criteria:

• Psychiatric hospitalization during the current major depressive episode.

• History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.

• Participants who, in the Investigator's judgment, are at significant risk for suicide.

• Pregnant or planning to become pregnant.

• Breast-feeding or planning to breast-feed.