The primary objective is to test the hypothesis that quetiapine XR (Extended Release) monotherapy or adjunctive therapy to antidepressant is superior to placebo monotherapy or placebo adjunctive therapy to antidepressant(s) in the acute treatment of depression symptoms in patients with MDD and comorbid GAD. The secondary objectives are to test the hypotheses that quetiapine XR is superior to placebo in the reduction of anxiety symptoms in patients with major depressive disorder and comorbid generalized anxiety disorder, the improvement of the quality of sleep in patients with major depressive disorder and comorbid generalized anxiety disorder and the improvement of the quality of life in patients with major depressive disorder and comorbid generalized anxiety disorder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
23
Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17)
The Hamilton Rating Scale for Depression (HAM-D-17) is a 17-item clinician-rated measure that queries symptoms of depression, with a possible total score ranging for 0 to 52. A total score of 0-7 indicates no depression, a total score of 8-12 indicates doubtful depression, a total score of 13-17 indicates mild depression, a total score of 18-24 indicates moderate depression and a total score of 25-52 indicates severe depression.
Time frame: Week 0 - Week 8
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