Study of ALTO-100 Compared to Placebo in Adults With Bipolar Disorder Currently Experiencing Major Depression

What this Trial Is About

Researchers are evaluating the antidepressant effects of ALTO-100 compared to a placebo in adults with Bipolar Disorder I or II who are currently experiencing a major depressive episode. This study aims to understand how patient characteristics influence the drugs effectiveness when added to a mood stabilizer andor atypical antipsychotic treatment. The study also assesses safety, tolerability, and efficacy during an open-label treatment phase following the initial blinded period. Participants will be randomly assigned to receive either ALTO-100 40 mg tablets or a matching placebo twice daily for six weeks during the double-blind phase. Those who qualify and continue into the open-label phase will receive ALTO-100 40 mg tablets twice daily for up to seven additional weeks. The study involves careful monitoring of depressive symptoms using standardized rating scales and safety evaluations throughout both study periods. During the trial, participants will undergo regular assessments including the Montgomery-sberg Depression Rating Scale MADRS, Patient Health Questionnaire PHQ-9, and Clinician Global Impression Scale-severity CGI-S. Safety monitoring covers adverse events, vital signs like heart rate and blood pressure, weight, and suicidality using the CHRT-SR12 scale. The total study duration for each participant can extend up to 13 weeks, with close follow-up to evaluate treatment effects and safety.

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