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

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 valproicacid (VPA, any form) or combination of Li + LMG or Li + VPA for at least 6 weekswith 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 itscomponents/excipients

• Concurrent or recent participation in another clinical trial for mental illnessinvolving an investigational product or device