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Evaluating ALTO-100 for treating depression in bipolar disorder

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

Phase 2 Interventional Alto Neuroscience · NCT06656416

This study is testing if a new medication called ALTO-100 can help people with bipolar disorder who are having a major depressive episode feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorAlto Neuroscience Industry-sponsored
Locations27 sites (Chandler, Arizona and 26 other locations)
Trial IDNCT06656416 on ClinicalTrials.gov

What this trial studies

This study aims to compare the antidepressant effects of ALTO-100 against a placebo in patients diagnosed with bipolar disorder I or II who are experiencing a major depressive episode. Participants will be receiving a mood stabilizer and will be monitored for safety, tolerability, and efficacy during a double-blind phase followed by an open-label treatment period. The study seeks to understand how patient characteristics may influence treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with bipolar disorder I or II who are currently experiencing a major depressive episode and are stable on a mood stabilizer.

Not a fit: Patients with unstable medical conditions, severe substance use disorders, or those with a history of allergic reactions to ALTO-100 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from depression associated with bipolar disorder.

How similar studies have performed: While there have been studies on bipolar disorder treatments, the specific approach of using ALTO-100 in this context is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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 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

Exclusion Criteria:

* 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

Where this trial is running

Chandler, Arizona and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bipolar Disorder I or II With a Major Depressive EpisodeBipolar IBipolar IIMajor Depressive Episode
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.