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

Description

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, 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

Talk to us

Study Overview

On this page

Study Details

Study overview

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, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.

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

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

Condition
Bipolar Disorder I or II with a Major Depressive Episode
Intervention / Treatment

-

Contacts and Locations

Chandler

Site 6036, Chandler, Arizona, United States, 85224

Phoenix

Site 6000, Phoenix, Arizona, United States, 85012

Yuma

Site 6087, Yuma, Arizona, United States, 85364

Imperial

Site 6081, Imperial, California, United States, 92251

Oceanside

Site 6082, Oceanside, California, United States, 92056

Lauderhill

Site 6067, Lauderhill, Florida, United States, 33319

Atlanta

Site 6068, Atlanta, Georgia, United States, 30328

Peachtree Corners

Site 6064, Peachtree Corners, Georgia, United States, 30071

Baltimore

Site 6151, Baltimore, Maryland, United States, 21229

Lincoln

Site 6142, Lincoln, Nebraska, United States, 68526

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have a diagnosis of BD-I or BD-II as well as BD-D
  • * At baseline, taking a mood stabilizer, lithium (LI) or lamotrigine (LMG) or valproic acid (VPA, any form) or combination of Li + LMG or Li + VPA for at least 6 weeks with no dose modifications in the past 2 weeks
  • * Willing to comply with all study assessments and procedures
  • * Must not be pregnant or breastfeeding at time of enrollment or throughout study
  • * Evidence of unstable medical condition
  • * Concurrent use of any prohibited medications or substance use disorder
  • * Diagnosed psychotic disorder (other than mania or depression)
  • * Current moderate or severe substance use disorder
  • * Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients
  • * Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alto Neuroscience,

Mallory Loflin, PhD, STUDY_DIRECTOR, Alto Neuroscience

Study Record Dates

2026-10-09