- ALTO-100 in Bipolar Disorder With Depression (BD-D) — Recruiting • Phase II • Mental Health / Psychiatry • NCT06656416.
- ALTO-100 tested against placebo for treating depression in bipolar disorder patients already on mood stabilizers or antipsychotics.
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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: Bipolar Disorder I or II With a Major Depressive Episode Interventions: ALTO-100, Placebo Lead Sponsor: Alto Neuroscience Planned Enrollment: 200 participants