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

Sponsored by Alto Neuroscience

About this trial

Last updated 2 years ago

Study ID

ALTO-300-004

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 74 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status