ALTO-100 in Major Depressive Disorder

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-100.

• 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

• Either currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks, or are not taking an antidepressant medication

• Willing to comply with all study assessments and procedures

• Must not be pregnant or breastfeeding at time of enrollment or throughout study

• Must have access with privacy to a computer with a keyboard and internet

Exclusion Criteria:

• Evidence of acute or unstable cardiovascular, respiratory, hepatic, or other major disease

• Active suicidal ideation

• Severe impediment to vision, hearing, and/or hand movement

• Diagnosed bipolar disorder or psychotic 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