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

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.

Timeline

Start

2024-10-02

Primary completion

2026-08

Completion

2026-10

Drugs

Indications