Trials / Recruiting
RecruitingNCT06254612
A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
A Multi-center, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 456 (estimated)
- Sponsor
- Sirtsei Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2B clinical study evaluating the effectiveness and safety of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SP-624 | Once daily oral administration of two capsules totaling 20 mg/day |
| DRUG | Placebo | Once daily oral administration of two matching placebo capsules |
Timeline
- Start date
- 2024-03-25
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
- First posted
- 2024-02-12
- Last updated
- 2026-04-01
Locations
50 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06254612. Inclusion in this directory is not an endorsement.