EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)
| Status: | Completed |
|---|---|
| Conditions: | Anxiety |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 9/28/2018 |
| Start Date: | January 2015 |
| End Date: | May 2016 |
A Randomized Double-Blind, Placebo Controlled, Flexible Dose, Parallel Group Study of Extended-Release Lorazepam (EDG004) for the Treatment of Generalized Anxiety Disorder (GAD)
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.
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.
Inclusion Criteria:
- Men and women between the ages of 18-65 years and
- Diagnosed with GAD and
- No other psychiatric conditions, and are otherwise medically healthy.
Exclusion Criteria:
- Women who are pregnant or lactating.
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