ALTO-100 in MDD and/or PTSD

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• 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 (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

• 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 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