Trials / Recruiting
RecruitingNCT06656416
ALTO-100 in Bipolar Disorder With Depression (BD-D)
A Randomized, Double-Blind, Placebo-Controlled Study Followed by Open-Label Treatment of ALTO-100 in Adults With Bipolar Disorder Currently Experiencing a Major Depressive Episode
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Alto Neuroscience · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer and/or atypical antipsychotic, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALTO-100 | ALTO-100 40 mg tablet BID |
| DRUG | Placebo | Placebo tablet BID |
Timeline
- Start date
- 2024-10-02
- Primary completion
- 2026-08-01
- Completion
- 2026-10-01
- First posted
- 2024-10-24
- Last updated
- 2025-07-16
Locations
27 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06656416. Inclusion in this directory is not an endorsement.