RE104 Safety and Efficacy Study in Generalized Anxiety Disorder
Recruiting · NCT07489651 · Interventional (participants receive a specific treatment) · Lead sponsor: Reunion Neuroscience Inc
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboRE104 for Injection
What this trial is about
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.
Who can take part
Age range
18 Years to 74 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
- Has Generalized Anxiety Disorder as defined by DSM-5-TR
- If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant.
- Is willing and able to comply with the conditions and requirements of the study
Exclusion criteria
- Has a significant risk of suicide
- Has an active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder
- Has other concurrent psychiatric disorders that is the primary disorder.
- Has other medically significant conditions rendering unsuitability for the study
- Has used or will need to use prohibited medications or therapies
- Has a known sensitivity or intolerance to study intervention or potential rescue medications
Where it is running
28 locations listed across 17 US states.
- University of Alabama (UAB) Clinical Research Unit (CRU) - Birmingham, Alabama, United States
- Lighthouse Psychiatry - Gilbert, Arizona, United States
- Preferred Research Partners, Inc. - Little Rock, Arkansas, United States
- Collaborative Neuroscience Research, LLC - Garden Grove, California, United States
- Kadima Neuropsychiatry Institute - La Jolla, California, United States
- Open Mind Therapeutics - San Francisco, California, United States
- TRIP Clinic at Psychedelic Science Institute - Santa Monica, California, United States
- Innovative Clinical Research, Inc. - Lauderhill, Florida, United States
- University of South Florida - Tampa, Florida, United States
- Atlanta Center for Medical Research - Atlanta, Georgia, United States
- CenExel iResearch, LLC - Decatur, Georgia, United States
- Evergreen Clinical Trials - Norcross, Georgia, United States
- CenExel iResearch, LLC - Savannah, Georgia, United States
- Uptown Research Institute - Chicago, Illinois, United States
- Henry Ford Medical Center - Columbus - Novi, Michigan, United States
- Midwest Research Group - Saint Charles, Missouri, United States
- UNM Research Program Psychedelic Therapies - Albuquerque, New Mexico, United States
- NYU-H+C Clinical and Translational Science Institute - New York, New York, United States
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States
- Neuro-Behavioral Clinical Research, Inc. - North Canton, Ohio, United States
- Summit Headlands LLC - Portland, Oregon, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Suburban Research Associates - West Chester, Pennsylvania, United States
- Austin Clinical Trial Partners - Austin, Texas, United States
- BioBehavioral Research Austion - Austin, Texas, United States
- Aim Trials, LLC - Plano, Texas, United States
- Cedar Clinical Research - Draper, Utah, United States
- Inner Space State Street - Orem, Utah, United States