Clinical Trial

ALTO-100 in Bipolar Disorder With Depression (BD-D)

Recruiting Phase 2
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-22.
Trial Details
NCT Number NCT06656416
Lead Sponsor Alto Neuroscience
Conditions Bipolar Disorder I or II With a Major Depressive Episode
Enrollment 200 participants
Start Date 2024-10-02
Primary Completion 2026-08 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2025-07-16