Study of ALTO-300 in MDD

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used 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 Visit 2, currently taking a single SSRI, SNRI, 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

• Nightly use of sleep medication

• Diagnosed bipolar disorder, psychotic disorder, or dementia

• Current moderate or severe substance use disorder

• Has a history of hypersensitivity or allergic reaction to ALTO-300 or any of its components/excipients

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