Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
245 participants
INTERVENTIONAL
2021-12-20
2022-12-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ALTO-100
ALTO-100 PO tablet, daily dosing 8 weeks
ALTO-100 PO tablet
one tablet twice daily
Interventions
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ALTO-100 PO tablet
one tablet twice daily
Eligibility Criteria
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Inclusion Criteria
* At baseline, either not taking an antidepressant medication, or currently taking a SSRI, SNRI, mirtazapine, 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
* Active suicidal ideation
* Diagnosed bipolar disorder, psychotic disorder, or dementia
* Current moderate or severe substance use 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
18 Years
69 Years
ALL
No
Sponsors
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Alto Neuroscience
INDUSTRY
Responsible Party
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Locations
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Site 136
Tempe, Arizona, United States
Site 139
Little Rock, Arkansas, United States
Site 141
Costa Mesa, California, United States
Site 118
Fresno, California, United States
Site 116
Martinez, California, United States
Site 116
Mather, California, United States
Site 150
Boca Raton, Florida, United States
Site 112
Doral, Florida, United States
Site 155
Elgin, Illinois, United States
Site 137
Noblesville, Indiana, United States
Site 151
Baltimore, Maryland, United States
Site 109
Belmont, Massachusetts, United States
Site 108
Jackson, Mississippi, United States
Site 142
Lincoln, Nebraska, United States
Site 144
Las Vegas, Nevada, United States
Site 146
Middleburg Heights, Ohio, United States
Site 147
Fort Worth, Texas, United States
Site 148
Fort Worth, Texas, United States
Site 120
Houston, Texas, United States
Site 113
Houston, Texas, United States
Site 121
Draper, Utah, United States
Site 105
Seattle, Washington, United States
NTC Seattle (105a)
Tacoma, Washington, United States
Countries
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Other Identifiers
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ALTO-100-001
Identifier Type: -
Identifier Source: org_study_id