RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

Summary

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

Conditions2

Interventions1

Locations28 sites

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