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Study of ALTO-300 in MDD

RECRUITINGPhase 2Sponsored by Alto Neuroscience
Actively Recruiting
PhasePhase 2
SponsorAlto Neuroscience
Started2023-06-08
Est. completion2026-12
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
Locations45 sites
View on ClinicalTrials.gov →

NCT05922878

Summary

The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.

Eligibility

Age: 18 Years – 70 YearsHealthy volunteers accepted
Inclusion Criteria:

* Have a diagnosis of moderate to severe major depressive disorder (MDD)
* At Visit 1, currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks by Visit 2
* 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 medical condition
* Nightly use of sleep medication
* Diagnosed bipolar disorder, psychotic disorder, or dementia
* Current moderate or severe substance use disorder
* Has a history of hypersensitivity or allergic reaction to ALTO-300 or any of its components/excipients
* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Conditions2

DepressionMajor Depressive Disorder

Interventions1

ALTO-300

Locations45 sites

Site 200
Phoenix, Arizona, 85012
Site 189
Phoenix, Arizona, 85021
Site 187
Yuma, Arizona, 85364
Site 193
Rogers, Arkansas, 72758
Site 218
Bellflower, California, 90706

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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