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ALTO-100 in MDD and/or PTSD | Clinical Trials | Clareo Health

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COMPLETEDPhase 2NCT05117632

ALTO-100 in MDD and/or PTSD

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

Lead sponsor: Alto Neuroscience•23 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Alto Neuroscience

Age

18 - 69 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Have a diagnosis of moderate to severe major depressive disorder (MDD) and/or post-traumatic stress disorder (PTSD)
•At baseline, either not taking an antidepressant medication, or currently taking a SSRI, SNRI, mirtazapine, or bupropion 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

•Evidence of unstable cardiovascular, respiratory, liver, or renal impairment or disease
•Active suicidal ideation
•Diagnosed bipolar disorder, psychotic disorder, or dementia
•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 1, 2023Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment245

Start dateDec 2021

Last updatedDec 1, 2023

Condition

Major Depressive Disorder Post Traumatic Stress Disorder

Locations shown

Site 136

Tempe, Arizona

Site 139

Little Rock, Arkansas

Site 141

Costa Mesa, California

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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: December 1, 2023Data synced to Clareo: June 28, 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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