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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
495
Extended-release lorazepam capsules
Placebo capsules
Multiple Investigational Sites
Multiple Locations, California, United States
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42)
HAM-A Total Score was rated by the clinician. Scores range from 0 to 56. A lower score is favorable. Baseline was defined as the last non-missing value prior to receiving double-blind study drug.
Time frame: Day 42 (Visit 7)
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42)
Measured on a 7-point scale 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Baseline was defined as the last non-missing value prior to receiving double-blind study drug.
Time frame: Day 42 (Visit 7)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.