Study of ALTO-300 in MDD
Recruiting · NCT05922878 · Interventional (participants receive a specific treatment) · Lead sponsor: Alto Neuroscience
View the official record on ClinicalTrials.gov →Interventions studied
ALTO-300Placebo
What this trial is about
The purpose of this study is to determine efficacy differences between ALTO-300 and placebo, used adjunctively to an antidepressant, related to patient characteristics.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
45 locations listed across 21 US states.
- Site 200 - Phoenix, Arizona, United States
- Site 189 - Phoenix, Arizona, United States
- Site 187 - Yuma, Arizona, United States
- Site 193 - Rogers, Arkansas, United States
- Site 218 - Bellflower, California, United States
- Site 217 - Glendale, California, United States
- Site 335 - Lafayette, California, United States
- Site 209 - Los Angeles, California, United States
- Site 219 - Mather, California, United States
- Site 194 - Mission Viejo, California, United States
- Site 197 - Temecula, California, United States
- Site 203 - Colorado Springs, Colorado, United States
- Site 349 - Evergreen, Colorado, United States
- Site 214 - Norwalk, Connecticut, United States
- Site 159 - Clermont, Florida, United States
- Site 225 - Miami Gardens, Florida, United States
- Site 190 - Miami Lakes, Florida, United States
- Site 161 - Okeechobee, Florida, United States
- Site 221 - Tampa, Florida, United States
- Site 220 - West Palm Beach, Florida, United States
- Site 224 - Savannah, Georgia, United States
- Site 208 - Snellville, Georgia, United States
- Site 119 - Boise, Idaho, United States
- Site 310 - Chicago, Illinois, United States
- Site 201 - Marrero, Louisiana, United States
- Site 198 - Monroe, Louisiana, United States
- Site 215 - Jackson, Mississippi, United States
- Site 344 - Las Vegas, Nevada, United States
- Site 114 - Albuquerque, New Mexico, United States
- Site 191 - Rochester, New York, United States
- Site 192 - Staten Island, New York, United States
- Site 199 - Hickory, North Carolina, United States
- Site 202 - Cincinnati, Ohio, United States
- Site 195 - Oklahoma City, Oklahoma, United States
- Site 216 - Allentown, Pennsylvania, United States
- Site 350 - Media, Pennsylvania, United States
- Site 352 - Moosic, Pennsylvania, United States
- Site 102 - Dallas, Texas, United States
- Site 347 - Fort Worth, Texas, United States
- Site 148 - Fort Worth, Texas, United States
- Site 206 - Missouri City, Texas, United States
- Site 353 - Plano, Texas, United States
- Site 196 - Richmond, Texas, United States
- Site 207 - Clinton, Utah, United States
- Site 211 - Roanoke, Virginia, United States