This multi-centred study will be conducted at three centres. The design will be a randomized, placebo-controlled, parallel-group one. This investigation will evaluate the efficacy of add-on Quetiapine XR (extended release) treatment for patients who meet diagnostic criteria for depressive disorders and one or more comorbid anxiety disorder.
The primary objective is to examine the beneficial effect of quetiapine augmentation of first-line antidepressants in refractory depression with co-morbid anxiety, compared to placebo. It is hypothesized that significant improvement on depression and anxiety symptoms will be seen as evidenced by reduction in Hamilton Depression Rating Scale (HAMD-17) and Hamilton Anxiety Scale (HAMA) scores after the 12 week treatment period for those who received Quetiapine XR augmentation compared to those who received placebo.2.2 Secondary objectives: 1) To establish the tolerability and safety of Quetiapine XR versus Placebo in patients with co-morbid depressive and anxiety disorders;2) To assess and compare the efficacy of Quetiapine XR versus Placebo improving quality of life in patients with co-morbid depressive and anxiety disorders.; 3) To assess and compare the efficacy of Quetiapine XR versus Placebo on clinical measures symptoms associated to co-morbid depressive and anxiety disorders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
Patients will be initiated on 50 mg of Quetiapine XR and will be titrated to a maximum dose of 300 mg based on response and tolerability. Dosing will be flexible up to Week 8, and then will remain fixed for until the end of the 12 week period.
Patients will be initiated on 50 mg of Placebo and will be titrated to a maximum dose of 300 mg based on response and tolerability. Dosing will be flexible up to Week 8, and then will remain fixed for until the end of the 12 week period.
Chatham-Kent Health Alliance
Chatham, Ontario, Canada
Centre for Neuropsychiatric Study
Markham, Ontario, Canada
Credit Valley Medical Arts Centre
Mississauga, Ontario, Canada
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Hamilton Depression Rating Scale (HAMD-17)
Time frame: 12 weeks
Hamilton Anxiety Scale
Time frame: Baseline, 6 weeks and 12 weeks
Quality of Life Enjoyment and Satisfaction Scale
Time frame: Baseline, 6 weeks and 12 weeks
Penn State Worry Questionnaire
Time frame: Baseline, 6 weeks and 12 weeks
Panic Disorder Severity Scale
Time frame: Baseline, 6 weeks and 12 weeks
Leibowitz Social Anxiety Scale
Time frame: Baseline, 6 weeks and 12 weeks
Post-traumatic Diagnostic Scale
Time frame: Baseline, 6 weeks and 12 weeks
Clinical Global Impression Scale
Time frame: Baseline, 6 weeks and 12 weeks
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