A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder
Alto Neuroscience
Summary
The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugALTO-300
ALTO-300 capsule QD
- DrugPlacebo
Placebo capsule QD
Locations (45)
- Site 200Phoenix, Arizona
- Site 189Phoenix, Arizona
- Site 187Yuma, Arizona
- Site 193Rogers, Arkansas
- Site 218Bellflower, California
- Site 217Glendale, California