RecruitingPhase 2NCT06656416

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

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

Sponsor

Alto Neuroscience

Enrollment

200 participants

Start Date

Oct 2, 2024

Study Type

INTERVENTIONAL

Conditions

Bipolar Disorder I or II With a Major Depressive Episode

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing ALTO-100 — an experimental drug — in people with bipolar disorder who are currently experiencing a depressive episode (bipolar depression), while continuing their existing mood-stabilizing or antipsychotic medications. **You may be eligible if...** - You have been diagnosed with bipolar I or bipolar II disorder and are currently experiencing depression - You are already taking a mood stabilizer (lithium, lamotrigine, or valproic acid) and/or an approved antipsychotic at a stable dose for at least 6 weeks - You are willing to follow all study procedures and are not pregnant or breastfeeding **You may NOT be eligible if...** - You have a psychotic disorder unrelated to bipolar disorder - You are currently using prohibited medications or have a substance use disorder - You are medically unstable - Your current medications have changed in the past 2 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALTO-100

ALTO-100 40 mg tablet BID

DRUGPlacebo

Placebo tablet BID

Locations(27)

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

Site 6112

Colorado Springs, Colorado, United States

Site 6067

Lauderhill, Florida, United States

Site 6068

Atlanta, Georgia, United States

Site 6064

Peachtree Corners, Georgia, United States

Site 6151

Baltimore, Maryland, United States

Site 6076

Bel Air, Maryland, United States

Site 6062

Gaithersburg, Maryland, United States

Site 6142

Lincoln, Nebraska, United States

Site 6144

Las Vegas, Nevada, United States

Site 6104

Las Vegas, Nevada, United States

Site 6066

Toms River, New Jersey, United States

Site 6014

Albuquerque, New Mexico, United States

Site 6078

Albuquerque, New Mexico, United States

6065

North Canton, Ohio, United States

Site 6075

Westlake, Ohio, United States

Site 6072

Houston, Texas, United States

Site 6121

Draper, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT06656416