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

Alto Neuroscience

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: ALTO-300 PO Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05157945

ALTO-300-004

Details and patient eligibility

About

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

Enrollment: 148 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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148 participants in 1 patient group

ALTO-300

Experimental group

Description:

ALTO-300 tablet PO; daily dosing 8 weeks

Treatment:

Drug: ALTO-300 PO Tablet