Study of ALTO-300 in MDD

Study Status: Recruiting

The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.

Sex: ALL
Minimum Age: 18 Years
Maximum Age: 70 Years

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

Inclusion Criteria

Have a diagnosis of moderate to severe major depressive disorder (MDD)
At Visit 1, currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks by Visit 2
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 medical condition
Nightly use of sleep medication
Diagnosed bipolar disorder, psychotic disorder, or dementia
Current moderate or severe substance use 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

Conditions

Major Depressive Disorder

Intervention/Treatment

DRUG : ALTO-300
DRUG : Placebo

Sponsor

Alto Neuroscience

Principal Investigator(s)

Adam Savitz, MD, PhD, STUDY_DIRECTOR, Alto Neuroscience

Phase

PHASE2