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