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.
- Men and women between the ages of 18-65 years and
- Diagnosed with GAD and
- No other psychiatric conditions, and are otherwise medically healthy.
- Women who are pregnant or lactating.