RecruitingPhase 2NCT05922878
Study of ALTO-300 in MDD
A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder
Sponsor
Alto Neuroscience
Enrollment
321 participants
Start Date
Jun 8, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria4
- Have a diagnosis of moderate to severe major depressive disorder (MDD)
- At Visit 1, currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks by Visit 2
- Willing to comply with all study assessments and procedures
- Must not be pregnant or breastfeeding at time of enrollment or throughout study
Exclusion Criteria6
- 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
Interventions
DRUGALTO-300
ALTO-300 capsule QD
DRUGPlacebo
Placebo capsule QD
Locations(45)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05922878
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