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
301 participants
INTERVENTIONAL
2023-01-10
2024-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALTO-100
Participants will receive ALTO-100 tablet twice daily, from Day 1 to Day 42 in double blind (DB) treatment period. Eligible participants who will enter the open label (OL) treatment period will receive ALTO-100 tablet twice daily from OL baseline until the end of OL period/early termination visit (Up to 7 weeks).
ALTO-100
ALTO-100 tablet BID
Placebo DB
Participants will receive matching placebo tablet twice daily, from Day 1 to Day 42 in double blind (DB) treatment period.
Placebo
Placebo tablet BID
Interventions
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ALTO-100
ALTO-100 tablet BID
Placebo
Placebo tablet BID
Eligibility Criteria
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Inclusion Criteria
* At baseline, either not taking an antidepressant medication, or currently taking a single 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
* 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
64 Years
ALL
No
Sponsors
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Alto Neuroscience
INDUSTRY
Responsible Party
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Principal Investigators
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Adam Savitz, MD, PhD
Role: STUDY_DIRECTOR
Alto Neuroscience
Locations
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Site 174
Birmingham, Alabama, United States
Site 173
Huntsville, Alabama, United States
Site 136
Chandler, Arizona, United States
Site 139
Little Rock, Arkansas, United States
Site 141
Costa Mesa, California, United States
Site 118
Fresno, California, United States
Site 181
Imperial, California, United States
Site 182
Oceanside, California, United States
Site 188
Oceanside, California, United States
Site 179
Rancho Cucamonga, California, United States
Site 116
Sacramento, California, United States
Site 185
Centennial, Colorado, United States
Site 186
Brooksville, Florida, United States
Site 204
Jacksonville, Florida, United States
Site 205
Orlando, Florida, United States
Site 212
Tampa, Florida, United States
Site 213
Tampa, Florida, United States
Site 137
Carmel, Indiana, United States
Site 151
Baltimore, Maryland, United States
Site 108
Jackson, Mississippi, United States
Site 171
Jackson, Mississippi, United States
Site 142
Lincoln, Nebraska, United States
Site 144
Las Vegas, Nevada, United States
Site 178
Albuquerque, New Mexico, United States
Site 184
Brooklyn, New York, United States
Site 180
New York, New York, United States
Site 210
New York, New York, United States
Site 175
Westlake, Ohio, United States
Site 157
North Charleston, South Carolina, United States
Site 183
Memphis, Tennessee, United States
Site 147
Fort Worth, Texas, United States
Site 120
Houston, Texas, United States
Site 172
Houston, Texas, United States
Site 121
Draper, Utah, United States
Countries
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Other Identifiers
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ALTO-100-201
Identifier Type: -
Identifier Source: org_study_id
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