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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RECRUITING
PHASE2
321 participants
INTERVENTIONAL
2023-06-08
2026-12-31
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-300
Participants will receive ALTO-300 capsule once daily in the evening, 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-300 capsule once daily in the evening from OL baseline until the end of OL period/early termination visit (Up to 8 weeks).
ALTO-300
ALTO-300 capsule QD
Placebo
Participants will receive matching placebo capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period.
Placebo
Placebo capsule QD
Interventions
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ALTO-300
ALTO-300 capsule QD
Placebo
Placebo capsule QD
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
70 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 200
Phoenix, Arizona, United States
Site 189
Phoenix, Arizona, United States
Site 187
Yuma, Arizona, United States
Site 193
Rogers, Arkansas, United States
Site 218
Bellflower, California, United States
Site 217
Glendale, California, United States
Site 335
Lafayette, California, United States
Site 209
Los Angeles, California, United States
Site 219
Mather, California, United States
Site 194
Mission Viejo, California, United States
Site 197
Temecula, California, United States
Site 203
Colorado Springs, Colorado, United States
Site 349
Evergreen, Colorado, United States
Site 214
Norwalk, Connecticut, United States
Site 159
Clermont, Florida, United States
Site 225
Miami Gardens, Florida, United States
Site 190
Miami Lakes, Florida, United States
Site 161
Okeechobee, Florida, United States
Site 221
Tampa, Florida, United States
Site 220
West Palm Beach, Florida, United States
Site 224
Savannah, Georgia, United States
Site 208
Snellville, Georgia, United States
Site 119
Boise, Idaho, United States
Site 310
Chicago, Illinois, United States
Site 201
Marrero, Louisiana, United States
Site 198
Monroe, Louisiana, United States
Site 215
Jackson, Mississippi, United States
Site 344
Las Vegas, Nevada, United States
Site 114
Albuquerque, New Mexico, United States
Site 191
Rochester, New York, United States
Site 192
Staten Island, New York, United States
Site 199
Hickory, North Carolina, United States
Site 202
Cincinnati, Ohio, United States
Site 195
Oklahoma City, Oklahoma, United States
Site 216
Allentown, Pennsylvania, United States
Site 350
Media, Pennsylvania, United States
Site 352
Moosic, Pennsylvania, United States
Site 102
Dallas, Texas, United States
Site 347
Fort Worth, Texas, United States
Site 148
Fort Worth, Texas, United States
Site 206
Missouri City, Texas, United States
Site 353
Plano, Texas, United States
Site 196
Richmond, Texas, United States
Site 207
Clinton, Utah, United States
Site 211
Roanoke, Virginia, United States
Countries
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Central Contacts
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Other Identifiers
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ALTO-300-201
Identifier Type: -
Identifier Source: org_study_id
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