Phase 2b Study of ALTO-100 in MDD

• Status: Recruiting
• Trial end date: 2024-03-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine efficacy differences between ALTO-100 and placebo, used either as monotherapy or adjunctively to an antidepressant, related to patient characteristics.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alto Neuroscience

Criteria

Inclusion Criteria:

• Have a diagnosis of moderate to severe major depressive disorder (MDD)

• At baseline, either not taking an antidepressant medication, or currently taking a single SSRI, SNRI, mirtazapine, or bupropion 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

• Diagnosed bipolar disorder, psychotic disorder, or dementia

• 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