Status:
COMPLETED
Pilot Decentralized Trial
Lead Sponsor:
Alto Neuroscience
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-100.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05419869
Start Date
June 1 2022
End Date
January 26 2023
Last Update
January 18 2024
Active Locations (2)
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1
Site 160
Coral Gables, Florida, United States, 33134
2
Site 156
Jackson, Mississippi, United States, 39216