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
200 participants
INTERVENTIONAL
2024-10-02
2026-10-31
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-100
Participants will receive ALTO-100 40 mg tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period. Eligible participants who enter the open label (OL) treatment period will receive ALTO-100 40 mg tablet twice daily from OL baseline until the end of OL period/early termination visit (Up to 7 weeks).
ALTO-100
ALTO-100 40 mg tablet BID
Placebo DB
Participants will receive matching placebo tablet twice daily, from Day 1 to Week 6 in the double blind (DB) treatment period.
Placebo
Placebo tablet BID
Interventions
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ALTO-100
ALTO-100 40 mg tablet BID
Placebo
Placebo tablet BID
Eligibility Criteria
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Inclusion Criteria
* At baseline, taking a mood stabilizer, lithium (LI) or lamotrigine (LMG) or valproic acid (VPA, any form) or combination of Li + LMG or Li + VPA and/or taking an approved atypical antipsychotic medication (olanzapine, quetiapine, lurasidone, risperidone, ziprasidone, cariprazine, aripiprazole, lumateperone, and asenapine) 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
* Concurrent use of any prohibited medications or substance use disorder
* Diagnosed psychotic disorder (other than mania or depression)
* 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
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 6036
Chandler, Arizona, United States
Site 6000
Phoenix, Arizona, United States
Site 6087
Yuma, Arizona, United States
6039
Fayetteville, Arkansas, United States
6070
Little Rock, Arkansas, United States
Site 6081
Imperial, California, United States
6069
Los Angeles, California, United States
Site 6016
Mather, California, United States
Site 6082
Oceanside, California, United States
Site 6102
Riverside, California, United States
Site 6112
Colorado Springs, Colorado, United States
Site 6067
Lauderhill, Florida, United States
Site 6068
Atlanta, Georgia, United States
Site 6064
Peachtree Corners, Georgia, United States
Site 6151
Baltimore, Maryland, United States
Site 6076
Bel Air, Maryland, United States
Site 6062
Gaithersburg, Maryland, United States
Site 6142
Lincoln, Nebraska, United States
Site 6144
Las Vegas, Nevada, United States
Site 6104
Las Vegas, Nevada, United States
Site 6066
Toms River, New Jersey, United States
Site 6014
Albuquerque, New Mexico, United States
Site 6078
Albuquerque, New Mexico, United States
6065
North Canton, Ohio, United States
Site 6075
Westlake, Ohio, United States
Site 6072
Houston, Texas, United States
Site 6121
Draper, Utah, United States
Countries
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Central Contacts
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Other Identifiers
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ALTO-100-211
Identifier Type: -
Identifier Source: org_study_id
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