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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Bipolar Disorder I or II With a Major Depressive Episode

Eligibility basics and study details

Study type

Interventional

Phase

Phase 2

Ages

18 to 70 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Alto Neuroscience

Last updated on ClinicalTrials.gov

October 13, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites