RE104 Safety and Efficacy Study in Generalized Anxiety Disorder
Purpose
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.
Condition
- Generalized Anxiety Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 74 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
A single subcutaneous injection of 0.9% sodium chloride for injection |
|
|
Experimental 30 mg RE104 |
A single subcutaneous injection of 30 mg RE104 for Injection |
|
Recruiting Locations
Lighthouse Psychiatry
Gilbert, Arizona 85234
Gilbert, Arizona 85234
Open Mind Therapeutics
San Francisco, California 94114
San Francisco, California 94114
TRIP Clinic at Psychedelic Science Institute
Santa Monica, California 90404
Santa Monica, California 90404
University of South Florida
Tampa, Florida 33613
Tampa, Florida 33613
Atlanta Center for Medical Research
Atlanta, Georgia 30331
Atlanta, Georgia 30331
UNM Research Program Psychedelic Therapies
Albuquerque, New Mexico 14624
Albuquerque, New Mexico 14624
Austin Clinical Trial Partners
Austin, Texas 78737
Austin, Texas 78737
Cedar Clinical Research
Draper, Utah 84020
Draper, Utah 84020
Inner Space State Street
Orem, Utah 84058
Orem, Utah 84058
More Details
- Status
- Recruiting
- Sponsor
- Reunion Neuroscience Inc