RecruitingPhase 2NCT07553637
ALTO-207 in Adults With Treatment-resistant Depression (TRD)
A Randomized, Double-blind, Placebo-controlled Trial of ALTO-207 in Adults With Treatment-resistant Depression
Sponsor
Alto Neuroscience
Enrollment
178 participants
Start Date
May 1, 2026
Study Type
INTERVENTIONAL
Summary
The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF.
- Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe).
- Failure to respond (<50% improvement) to at least 2-5 antidepressant treatments (including the current treatment)
- Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline
Exclusion Criteria7
- Evidence of unstable medical condition
- Concurrent use of any prohibited medications or substance use disorder
- Diagnosed bipolar disorder or a psychotic disorder or symptoms
- Significant current PTSD symptoms or history of PTSD
- Clinically significant current impulse control difficulties
- Has a history of hypersensitivity or allergic reaction to ALTO-207 or any of its components/excipients
- Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
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Interventions
DRUGALTO-207
ALTO-207 BID
DRUGPlacebo
Matching Placebo
Locations(48)
View Full Details on ClinicalTrials.gov
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NCT07553637