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Sponsored by: |
Centre for Addiction and Mental Health |
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Information provided by: | Centre for Addiction and Mental Health |
ClinicalTrials.gov Identifier: | NCT00688818 |
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 treatment for patients who meet diagnostic criteria for depressive disorders and one or more comorbid anxiety disorder.
Condition | Intervention |
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Major Depressive Disorder Dysthymic Disorder Anxiety Disorders Generalized Anxiety Disorder Social Anxiety Disorder Panic Disorder Post-Traumatic Stress Disorder |
Drug: Quetiapine Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Placebo-Controlled Effectiveness Study of Quetiapine XR in Co-Morbid Depressive and Anxiety Disorders |
Estimated Enrollment: | 105 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Quetiapine
Patients will be initiated on 50 mg of Quetiapine XR and will be titrated to a maximum dose of 600 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.
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2: Placebo Comparator |
Drug: Placebo
placebo
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Arun Ravindran, MD | 416-535-8501 ext 6933 | Arun_Ravindran@camh.net |
Canada, Ontario | |
Centre for Addiction and Mental Health | |
Toronto, Ontario, Canada, M5T 1R8 | |
Centre for Neuropsychiatric Study | |
Markham, Ontario, Canada, L6B 1A1 | |
Credit Valley Medical Arts Centre | |
Mississauga, Ontario, Canada, L5M 4N4 |
Principal Investigator: | Arun Ravindran, MD | Centre for Addiction and Mental Health |
Responsible Party: | Centre for Addiction and Mental Health ( Dr. Arun Ravindran ) |
Study ID Numbers: | 183/2007 |
Study First Received: | May 30, 2008 |
Last Updated: | May 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00688818 |
Health Authority: | Canada: Health Canada |
Co-morbid depressive and anxiety disorders Quetiapine Randomized Placebo-controlled Double-blind Major depressive disorder |
Dysthymic disorder Anxiety disorders Generalized anxiety disorder Social anxiety disorder Panic disorder Post-traumatic stress disorder |
Depression Stress Depressive Disorder, Major Depressive Disorder Phobic Disorders Stress Disorders, Traumatic Behavioral Symptoms |
Quetiapine Panic Disorder Anxiety Disorders Mental Disorders Mood Disorders Stress Disorders, Post-Traumatic Dysthymic Disorder |
Tranquilizing Agents Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |