Conditions: Generalized Anxiety Disorder (GAD)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 495
Healthy volunteers: no

Brief summary:
To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0). Efficacy will be measured by a statistically significant greater mean reduction from baseline compared to endpoint in anxiety symptoms as measured by the total score of the clinician-rated Hamilton Rating Scale for Anxiety (HAM-A) for the EDG004 treatment group compared to placebo.

Detailed description:

Arms:
arm 1: EDG004 - Extended release lorazepam capsules arm 2: Placebo

Interventions: intervention 1: Extended-release lorazepam intervention 2: Placebo
Intervention descriptions: intervention 1: Extended-release lorazepam capsules intervention 2: Placebo capsules

Protocol document: