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A Randomized, Double-Blind, Placebo-Controlled Study Followed by Open-Label Treatment of ALTO-100 in Adults With Bipolar Disorder Currently Experiencing a Major Depressive Episode
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Site 6036
Chandler, Arizona, United States
Site 6000
Phoenix, Arizona, United States
Site 6087
Yuma, Arizona, United States
6039
Fayetteville, Arkansas, United States
6070
Little Rock, Arkansas, United States
Site 6081
Imperial, California, United States
6069
Los Angeles, California, United States
Site 6016
Mather, California, United States
Site 6082
Oceanside, California, United States
Site 6102
Riverside, California, United States
Start Date
October 2, 2024
Primary Completion Date
August 1, 2026
Completion Date
October 1, 2026
Last Updated
July 16, 2025
200
ESTIMATED participants
ALTO-100
DRUG
Placebo
DRUG
Lead Sponsor
Alto Neuroscience
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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