Overview
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.
Eligibility
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
