Trials / Completed
CompletedNCT06342310
RE104 Safety and Efficacy Study in Postpartum Depression
A Multicenter, Randomized, Double-Blind, Parallel-Group Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Patients With Postpartum Depression (PPD)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- Reunion Neuroscience Inc · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RE104 for Injection | Single, subcutaneous dose of RE104 for Injection |
Timeline
- Start date
- 2024-06-14
- Primary completion
- 2025-05-22
- Completion
- 2025-06-16
- First posted
- 2024-04-02
- Last updated
- 2025-07-23
Locations
38 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06342310. Inclusion in this directory is not an endorsement.