Trials / Recruiting
RecruitingNCT05922878
Study of ALTO-300 in MDD
A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 321 (estimated)
- Sponsor
- Alto Neuroscience · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALTO-300 | ALTO-300 capsule QD |
| DRUG | Placebo | Placebo capsule QD |
Timeline
- Start date
- 2023-06-08
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2023-06-28
- Last updated
- 2025-07-24
Locations
45 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05922878. Inclusion in this directory is not an endorsement.