Overview

ALTO-300 in Depression

Status:
Not yet recruiting
Trial end date:
2023-06-01
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

- Fluent in English and 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