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

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alto Neuroscience

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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