Pilot Decentralized Trial

An Open-Label Study of ALTO-100 in Adults With Major Depressive Disorder (MDD)

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

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