Evaluating ALTO-100 for treating depression in bipolar disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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, asenapine, Iloperidone and Milsaperidone) 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 it's running

• Site 6000
  Phoenix, Arizona, United States Recruiting
• Site 6133
  Little Rock, Arkansas, United States Recruiting
• Site 6153
  Chino, California, United States Recruiting
• 6069
  Los Angeles, California, United States Recruiting
• Site 6016
  Mather, California, United States Recruiting
• Site 6111
  Sacramento, California, United States Recruiting

+18 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Alto Neuroscience
• Email: clinical@altoneuroscience.com
• Phone: 650-200-0412

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ALTO-207 for adults with treatment-resistant depression

  This trial will test whether ALTO-207 reduces depressive symptoms more than placebo in adults whose depression has not improved after at least two antidepressant treatments.

  Recruiting at 40 sites Phase 2 Alto Neuroscience · Dothan, Alabama and 62 other locations · NCT07553637

• Evaluating ALTO-101 for cognitive impairment in schizophrenia

  This study is testing a new skin patch called ALTO-101 to see if it can help improve thinking skills in people with schizophrenia.

  Recruiting at 13 sites Phase 2 Alto Neuroscience · Garden Grove, California and 13 other locations · NCT06502964

• Evaluating ALTO-300 for treating major depressive disorder

  This study is testing if adding ALTO-300 to standard antidepressants can help people with moderate to severe depression feel better compared to a placebo.

  Recruiting at 30 sites Phase 2 Alto Neuroscience · Phoenix, Arizona and 74 other locations · NCT05922878

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.