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 be 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
Clareo Health | ALTO-100 in Bipolar Disorder With Depression (BD-D)
