The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
725
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum.
Time frame: From randomization (baseline) to week 4
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
The HADS-A is a 7 item, self administered instrument to measure level of anxiety. Each item is a score rate from 0 (happens rarely ) to 3 (happens frequently), and the items are totaled for a maximum score of 21. The mimimum score 0 indicates that the patient rarely suffered from anxiety symptoms.
Time frame: From randomization (baseline) to week 4
Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score
The HAM-A psychic anxiety factor score is calculated as the sum of 7 HAM-A individual items related with psychic anxiety ( each rated from 0 to 4, 0 is the best). The minimum score for HAM-A psychic anxiety factor is 0 and maximum score is 28, higher score indicates severe psychic anxiety symptoms.
Time frame: From baseline (randomization) to week 4
Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score
The HAM-A somatic factor score is calculated as the sum of 7 individual HAM-A items (each is rated from 0 to 4, 0 is the best) related with somatic anxiety symptoms. The minimum score for HAM-A somatic factor is 0 and maximum score is 28, higher score indicates severe somatic anxiety symptoms
Time frame: From baseline ( randomization) to week 4
Change in Sheehan Disability Scale (SDS) Global Total Score
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2 tablets taken twice a day for 28 days
Research Site
Birmingham, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
Arcadia, California, United States
Research Site
Beverly Hills, California, United States
Research Site
Cerritos, California, United States
Research Site
Chino, California, United States
Research Site
Encino, California, United States
Research Site
Los Alamitos, California, United States
Research Site
Novato, California, United States
Research Site
Oceanside, California, United States
...and 42 more locations
The Sheehan Disability Scale is a patient-rated measure of functional disability in 3 subscales: work, social, and family life. Each subscale is rated from 0 to 10, with 0 as the best. SDS global total score is calculated as the sum of 3 subscales and ranges from 0(unimpaired) to 30 (highly impaired)
Time frame: From baseline ( randomization) to week 4