Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at Mather, California and other locations
Dates
study started
study ends around

Description

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.

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

Keywords

Bipolar Disorder I or II With a Major Depressive Episode, Bipolar I, Bipolar II, Major Depressive Episode, ALTO-100

Eligibility

You can join if…

Open to people ages 18-70

  • 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 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
  • Willing to comply with all study assessments and procedures
  • Must not be pregnant or breastfeeding at time of enrollment or throughout study

You CAN'T join if...

  • 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

Locations

  • Site 6016 not yet accepting patients
    Mather California 95655 United States
  • 6069 accepting new patients
    Los Angeles California 90025 United States
  • Site 6144 accepting new patients
    Las Vegas Nevada 89102 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alto Neuroscience
Links
Sign up for this study
ID
NCT06656416
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated