RE104 Safety and Efficacy Study in Generalized Anxiety Disorder
ConditionGeneralized Anxiety Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorReunion Neuroscience Inc
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- RE104 for Injection
- Placebo
Treatment groups
64 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov