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
69 participants
INTERVENTIONAL
2024-03-25
2025-04-21
Brief Summary
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Participants will complete subjective response questionnaires and perform cognitive tasks during the single-dose period, in which participants will receive ALTO-203 25 μg and 75 μg, as well as placebo. During the multiple-dose period, participants will receive either ALTO-203 25 μg, 75 μg , or placebo. Safety will be assessed over the single dose and 28-day multiple dose periods.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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ALTO-203 25 μg
Drug: ALTO-203 25 μg
Single-Dose Treatment Period: Single Dose, ALTO-203 25 μg
Multi-Dose Treatment Period: ALTO-203 25 μg, administered orally, once daily for 28 days
ALTO-203 25 μg
Active, ALTO-203 25 μg
ALTO-203 75 μg
Drug: ALTO-203 75 μg
Single-Dose Treatment Period: Single Dose, ALTO-203 75 μg
Multi-Dose Treatment Period: ALTO-203 75 μg, administered orally, once daily for 28 days
ALTO-203 75 μg
Active, ALTO-203 75 μg
Placebo
Drug: Placebo
Single-Dose Treatment Period: Single Dose, Placebo
Multi-Dose Treatment Period: Placebo, administered orally, once daily for 28 days
Placebo
Comparator, Placebo-to-match
Interventions
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ALTO-203 25 μg
Active, ALTO-203 25 μg
ALTO-203 75 μg
Active, ALTO-203 75 μg
Placebo
Comparator, Placebo-to-match
Eligibility Criteria
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Inclusion Criteria
* Presence of anhedonia symptoms
* Not taking antidepressant at Screening Visit 2
* Willing to comply with all study assessments and procedures
Exclusion Criteria
* Diagnosed bipolar disorder, psychotic disorder, or dementia
* Concurrent use of prohibited medications
* Current moderate or severe substance use disorder
* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
25 Years
64 Years
ALL
No
Sponsors
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Alto Neuroscience
INDUSTRY
Responsible Party
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Locations
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Site 4058
Tucson, Arizona, United States
Site 4082
Oceanside, California, United States
Site 4023
Torrance, California, United States
Site 4059
Clermont, Florida, United States
Site 4005
Orlando, Florida, United States
Site 4031
Atlanta, Georgia, United States
Site 4054
Pikesville, Maryland, United States
Site 4036
Las Vegas, Nevada, United States
Site 4022
Marlton, New Jersey, United States
Site 4134
Princeton, New Jersey, United States
Site 4075
Westlake, Ohio, United States
Site 4040
Austin, Texas, United States
Site 4072
Houston, Texas, United States
Site 4007
Clinton, Utah, United States
Site 4033
Bellevue, Washington, United States
Countries
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Other Identifiers
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ALTO-203-201
Identifier Type: -
Identifier Source: org_study_id
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