|

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

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

Browse More Trials

Depression trials

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

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.