Trials / Completed
CompletedNCT05712187
Phase 2b Study of ALTO-100 in MDD
A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-100 With an Open-Label Extension in Adults With Major Depressive Disorder
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 301 (actual)
- Sponsor
- Alto Neuroscience · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine efficacy differences between ALTO-100 and placebo, used either as monotherapy or adjunctively to an antidepressant, related to patient characteristics.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALTO-100 | ALTO-100 tablet BID |
| DRUG | Placebo | Placebo tablet BID |
Timeline
- Start date
- 2023-01-10
- Primary completion
- 2024-09-05
- Completion
- 2024-10-24
- First posted
- 2023-02-03
- Last updated
- 2025-09-08
Locations
34 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05712187. Inclusion in this directory is not an endorsement.