Trials / Terminated
TerminatedNCT04855747
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-II Study)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 236 (actual)
- Sponsor
- Levomecor 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | REL-1017 | REL-1017 tablet |
| DRUG | Placebo | Placebo tablet |
Timeline
- Start date
- 2021-03-30
- Primary completion
- 2024-12-31
- Completion
- 2025-01-14
- First posted
- 2021-04-22
- Last updated
- 2025-11-06
Locations
70 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04855747. Inclusion in this directory is not an endorsement.