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Pilot Decentralized Trial | Clinical Trials | Clareo Health

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COMPLETEDPhase 2NCT05419869

Pilot Decentralized Trial

The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-100.

Lead sponsor: Alto Neuroscience•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Alto Neuroscience

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Have a diagnosis of moderate to severe major depressive disorder
•Either currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks, or are not taking an antidepressant medication
•Willing to comply with all study assessments and procedures
•Must not be pregnant or breastfeeding at time of enrollment or throughout study
•Must have access with privacy to a computer with a keyboard and internet

Exclusion Criteria

•Evidence of acute or unstable cardiovascular, respiratory, hepatic, or other major disease
•Active suicidal ideation
•Severe impediment to vision, hearing, and/or hand movement
•Diagnosed bipolar disorder or psychotic 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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 18, 2024Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment21

Start dateJun 2022

Last updatedJan 18, 2024

Condition

Major Depressive Disorder

Locations shown

Site 160

Coral Gables, Florida

Site 156

Jackson, Mississippi

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2024Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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