RecruitingBipolar Disorder I or II With a Major Depressive Episode

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

Eligible age

18–70 yrs

Accepts

All genders

Locations

14 states

Healthy volunteers

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About this study

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.

Sponsor: Alto Neuroscience

You may qualify if…

✓ 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 may not qualify 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