A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
| Condition | Major Depressive Disorder, Depression |
|---|---|
| Phase | Phase 3 |
| Sponsor | Levomecor Inc. |
| Status | Terminated |
| Enrollment | 236 participants |
| Interventions | REL-1017 |
| Start date | Mar 30, 2021 |
| Completion date | Dec 31, 2024 |
| Results posted | Jul 10, 2026 |
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.
Change From Baseline to Day 28 in MADRS Total Score
| REL-1017 | -14.81 ± 1.00 Scores on a scale (MADRS10) |
|---|---|
| Placebo | -13.9 ± 1.01 Scores on a scale (MADRS10) |
Open in BENITIONS View on ClinicalTrials.gov
Other trials for this condition
- CBT+ for Depression — University of Wisconsin, Madison
- Probing the Dorsolateral Prefrontal Cortex and Central Executive Network for Improving Neu — Stanford University
- Severe Asthma, MepolizumaB and Affect: SAMBA Study — University Hospital Southampton NHS Foundation Trust
- Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for — Levomecor Inc.
- Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders — Massachusetts General Hospital
- Individualized Functional Connectivity Targeting in aiTBS for Depression — Brigham and Women's Hospital