Trials / Completed
CompletedNCT05081167
A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of REL-1017 Monotherapy for Major Depressive Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 232 (actual)
- Sponsor
- Relmada Therapeutics, 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 a monotherapy for Major Depressive Disorder.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | REL-1017 | REL-1017 tablet |
| DRUG | Placebo | Placebo tablet |
Timeline
- Start date
- 2021-06-02
- Primary completion
- 2022-09-13
- Completion
- 2022-09-14
- First posted
- 2021-10-18
- Last updated
- 2024-03-26
- Results posted
- 2024-03-26
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05081167. Inclusion in this directory is not an endorsement.