Phase 2 Bipolar Disorder Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with Bipolar Disorder Type I or Type II, and are currently experiencing a depressive episode related to bipolar disorder
- You have been taking a mood stabilizer (such as lithium, lamotrigine, or valproic acid, alone or in combination) and/or an approved antipsychotic medication (such as quetiapine, aripiprazole, or similar) for at least 6 weeks, with no changes to your dose in the past 2 weeks
- You are willing to follow all study requirements and attend all assessments throughout the trial
- You are not pregnant and are not breastfeeding at the time of joining, and agree to remain so throughout the study
Who may not be able to join:
- You have an unstable or poorly controlled physical health condition
- You are currently taking any medications that are not allowed by the trial, or you have a substance use disorder
- You have been diagnosed with a psychotic disorder other than mania or depression (confirm with trial site)
- You currently have a moderate or severe problem with alcohol or drug use
- You have previously had an allergic reaction or sensitivity to ALTO-100 or any of its ingredients
- You are currently participating in, or have recently participated in, another clinical trial for a mental health condition that involves an experimental treatment or device
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Adam Savitz, MD, PhD, Alto Neuroscience
Phone: 650-200-0412
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
To assess efficacy of ALTO-100 versus placebo on depression symptoms in bipolar disorder in a pre-defined subgroup of participants as measured by the mean change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.