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
More Details
- Status
- Recruiting
- Sponsor
- Reunion Neuroscience Inc
