ALTO-207 in Adults With Treatment-resistant Depression (TRD)
Recruiting · NCT07553637 · Interventional (participants receive a specific treatment) · Lead sponsor: Alto Neuroscience
View the official record on ClinicalTrials.gov →Interventions studied
ALTO-207Placebo
What this trial is about
The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
Who can take part
Age range
18 Years to 75 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
- Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF.
- Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe).
- Failure to respond (\<50% improvement) to at least 2-5 antidepressant treatments (including the current treatment)
- Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline
Exclusion criteria
- Evidence of unstable medical condition
- Concurrent use of any prohibited medications or substance use disorder
- Diagnosed bipolar disorder or a psychotic disorder or symptoms
- Significant current PTSD symptoms or history of PTSD
- Clinically significant current impulse control difficulties
- Has a history of hypersensitivity or allergic reaction to ALTO-207 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
48 locations listed across 17 US states.
- Site 7074 - Birmingham, Alabama, United States
- Site 7173 - Dothan, Alabama, United States
- Site 7000 - Phoenix, Arizona, United States
- Site 7153 - Chino, California, United States
- Site 7156 - Oakland, California, United States
- Site 7082 - Oceanside, California, United States
- Site 7159 - Palo Alto, California, United States
- Site 7016 - Sacramento, California, United States
- Site 7144 - San Diego, California, United States
- Site 7171 - Valley Village, California, United States
- Site 7152 - Saint Augustine, Florida, United States
- Site 7148 - Albany, Georgia, United States
- Site 7146 - Atlanta, Georgia, United States
- Site 7064 - Peachtree Corners, Georgia, United States
- Site 7141 - Savannah, Georgia, United States
- Site 7169 - Indianapolis, Indiana, United States
- Site 7151 - Annapolis, Maryland, United States
- Site 7054 - Pikesville, Maryland, United States
- Site 7166 - Worcester, Massachusetts, United States
- Site 7155 - Ann Arbor, Michigan, United States
- Site 7154 - Bloomfield Hills, Michigan, United States
- Site 7170 - Amherst, New York, United States
- Site 7055 - Cedarhurst, New York, United States
- Site 7162 - Lewiston, New York, United States
- Site 7157 - Syracuse, New York, United States
- Site 7143 - Charlotte, North Carolina, United States
- Site 7029 - Cincinnati, Ohio, United States
- Site 7158 - Garfield Heights, Ohio, United States
- Site 7172 - East Providence, Rhode Island, United States
- Site 7176 - Dallas, Texas, United States
- Site 7160 - Fort Worth, Texas, United States
- Site 7150 - Galveston, Texas, United States
- Site 7175 - Houston, Texas, United States
- Site 7145 - Houston, Texas, United States
- Site 7161 - Irving, Texas, United States
- Site 7177 - Fairfax, Virginia, United States
- Site 7128 - Seattle, Washington, United States
- Site 7163 - South Charleston, West Virginia, United States
- Site 7419 - Antrim, United Kingdom
- Site 7411 - Birmingham, United Kingdom
- Site 7414 - Bristol, United Kingdom
- Site 7412 - Cardiff, United Kingdom
- Site 7418 - Exeter, United Kingdom
- Site 7415 - London, United Kingdom
- Site 7413 - Nottingham, United Kingdom
- Site 7410 - Oxford, United Kingdom
- Site 7402 - Prescot, United Kingdom
- Site 7416 - Sheffield, United Kingdom