NCT06011577

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

A Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as an Adjunctive Treatment for Major Depressive Disorder (RELIGHT)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Levomecor Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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 in patients with inadequate response to ongoing background antidepressant treatment. Eligible patients will continue to take their background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017 or placebo for a 4 week treatment period.

Conditions

• Major Depressive Disorder
• Depression

Interventions

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

Timeline

• Start date: 2023-08-17
• Primary completion: 2024-12-19
• Completion: 2024-12-19
• First posted: 2023-08-25
• Last updated: 2025-11-06

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated drug study