RECRUITING

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

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Conditions

Bipolar Disorder I or II With a Major Depressive EpisodeBipolar IBipolar IIMajor Depressive Episode

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2024-10-02
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06656416

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of BD-I or BD-II as well as BD-D
  2. * 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 and/or taking an approved atypical antipsychotic medication (olanzapine, quetiapine, lurasidone, risperidone, ziprasidone, cariprazine, aripiprazole, lumateperone, and asenapine) for at least 6 weeks with no dose modifications in the past 2 weeks
  3. * Willing to comply with all study assessments and procedures
  4. * Must not be pregnant or breastfeeding at time of enrollment or throughout study
  1. * Evidence of unstable medical condition
  2. * Concurrent use of any prohibited medications or substance use disorder
  3. * Diagnosed psychotic disorder (other than mania or depression)
  4. * Current moderate or severe substance use disorder
  5. * Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients
  6. * Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Contacts and Locations

Study Contact

Alto Neuroscience
CONTACT
650-200-0412
clinical@altoneuroscience.com

Principal Investigator

Adam Savitz, MD, PhD
STUDY_DIRECTOR
Alto Neuroscience

Study Locations (Sites)

Site 6036
Chandler, Arizona, 85224
United States
Site 6000
Phoenix, Arizona, 85012
United States
Site 6087
Yuma, Arizona, 85364
United States
6039
Fayetteville, Arkansas, 72703
United States
6070
Little Rock, Arkansas, 72204
United States
Site 6081
Imperial, California, 92251
United States
6069
Los Angeles, California, 90025
United States
Site 6016
Mather, California, 95655
United States
Site 6082
Oceanside, California, 92056
United States
Site 6102
Riverside, California, 92506
United States
Site 6112
Colorado Springs, Colorado, 80910
United States
Site 6067
Lauderhill, Florida, 33319
United States
Site 6068
Atlanta, Georgia, 30328
United States
Site 6064
Peachtree Corners, Georgia, 30071
United States
Site 6151
Baltimore, Maryland, 21229
United States
Site 6076
Bel Air, Maryland, 21015
United States
Site 6062
Gaithersburg, Maryland, 20877
United States
Site 6142
Lincoln, Nebraska, 68526
United States
Site 6144
Las Vegas, Nevada, 89102
United States
Site 6104
Las Vegas, Nevada, 89119
United States
Site 6066
Toms River, New Jersey, 08755
United States
Site 6014
Albuquerque, New Mexico, 87108
United States
Site 6078
Albuquerque, New Mexico, 87110
United States
6065
North Canton, Ohio, 44720
United States
Site 6075
Westlake, Ohio, 44145
United States
Site 6072
Houston, Texas, 77081
United States
Site 6121
Draper, Utah, 84020
United States

Collaborators and Investigators

Sponsor: Alto Neuroscience

  • Adam Savitz, MD, PhD, STUDY_DIRECTOR, Alto Neuroscience

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-02
Study Completion Date2026-10

Study Record Updates

Study Start Date2024-10-02
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Bipolar I
  • Bipolar II
  • Major Depressive Episode

Additional Relevant MeSH Terms

  • Bipolar Disorder I or II With a Major Depressive Episode