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

2021-01-08

Primary completion

2022-11-01

Completion

2022-11-10

Outcome

Missed primary endpoint

paper Conclusions: The primary end point was not met. PMID 38917366 ↗

Publications

• Results Fava M, Stahl SM, Pani L, De Martin S, Cutler AJ, Maletic V, Gorodetzky CW, Vocci FJ, Sapienza FL, Kosten TR, Kroger C, Champasa P, O'Gorman C, Guidetti C, Alimonti A, Comai S, Mattarei A, Folli F, Bushnell D, Traversa S, Inturrisi CE, Manfredi PL, Pappagallo M. Efficacy and Safety of Esmethadone (REL-1017) in Patients With Major Depressive Disorder and Inadequate Response to Standard Antidepressants: A Phase 3 Randomized Controlled Trial. J Clin Psychiatry. 2024 Jun 17;85(3):24m15265. doi: 10.4088/JCP.24m15265.
• Guidetti C, Papakostas GI, Stahl S, Pani L, De Martin S, Mattarei A, Comai S, Kroger C, Champasa P, Gorodetzky CW, Vocci FJ, Kosten TR, Bushnell D, Kappler M, Folli F, Inturrisi CE, Pappagallo M, Manfredi PL, Fava M. Depression severity and efficacy outcomes: post hoc analyses from a phase 3 trial of esmethadone for the adjunctive treatment of major depressive disorder with inadequate response to standard antidepressants. Int Clin Psychopharmacol. 2026 Jul 1;41(4):213-224. doi: 10.1097/YIC.0000000000000618. Epub 2026 Feb 17.

Drugs

Indications