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

Launched by ALTO NEUROSCIENCE · Oct 22, 2024

Keywords

ClinConnect Summary

This clinical trial, called ALTO-100, is investigating a new treatment for people with Bipolar Disorder I or II who are currently experiencing a major depressive episode. The goal is to see how effective ALTO-100 is compared to a placebo (a non-active treatment) when used alongside a mood stabilizer, which helps manage mood swings. The study will also look at how safe and well-tolerated ALTO-100 is over time.

To participate in this trial, individuals must be diagnosed with Bipolar Disorder I or II and have been stable on a mood stabilizer like lithium or lamotrigine for at least six weeks. Participants should be between 18 and 65 years old, and must not be pregnant or breastfeeding. During the trial, participants will receive either ALTO-100 or a placebo and will be monitored closely. This study is currently recruiting, so there is an opportunity for eligible individuals to take part in this important research.

Gender

ALL

Eligibility criteria

• 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, 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
• 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