ALTO-100 in MDD and/or PTSD

Alto Neuroscience

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder; Post Traumatic Stress Disorder

Treatments: Drug: ALTO-100 PO tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05117632

ALTO-100-001

Details and patient eligibility

About

The goal of this study is to collect biologically based data for defining predictors and correlates of the effects of ALTO-100.

Enrollment: 245 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a diagnosis of moderate to severe major depressive disorder (MDD) and/or post-traumatic stress disorder (PTSD)
• At baseline, either not taking an antidepressant medication, or currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
• 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 unstable cardiovascular, respiratory, liver, or renal impairment or disease
• Active suicidal ideation
• Diagnosed bipolar disorder, psychotic disorder, or dementia
• Current moderate or severe substance use disorder
• Has a history of hypersensitivity or allergic reaction to ALTO-100 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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245 participants in 1 patient group

ALTO-100

Experimental group

Description:

ALTO-100 PO tablet, daily dosing 8 weeks

Treatment:

Drug: ALTO-100 PO tablet