ALTO-300 in Depression (ALTO-300-004)

Completed · Phase 2

Conditions studied: Major Depressive Disorder

In brief

The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-300.

Key facts

Study ID

NCT05157945

Run by

Alto Neuroscience

People needed

148

Starts

2022-02-03

Expected to finish

2023-05-05

Last updated by the study team

2024-04-26

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of moderate to severe major depressive disorder
• Currently taking a SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
• Must have failed to adequately respond to the current antidepressant medication
• Willing to comply with all study assessments and procedures
• Must not be pregnant or breastfeeding at time of enrollment or throughout study

You may not qualify if…

• Evidence of liver impairment or disease
• Active suicidal ideation
• Moderate to severe Alcohol Use Disorder
• Diagnosed bipolar disorder or psychotic 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

Where it is running

• Cerebral - Atlanta — Atlanta, Georgia, United States
• Site 171 — Jackson, Mississippi, United States
• Cerebral - New York City — New York, New York, United States
• Cerebral - Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.