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| Sponsor: | Centre for Addiction and Mental Health |
|---|---|
| Information provided by (Responsible Party): | Arun Ravindran, Centre for Addiction and Mental Health |
| ClinicalTrials.gov Identifier: | NCT00688818 |
Purpose
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 |
|---|---|
|
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Quetiapine
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.
|
| Placebo Comparator: 2 |
Drug: Placebo
placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Arun Ravindran, MD, PhD | 416-535-8501 ext 6933 | Arun_Ravindran@camh.net |
| Canada, Ontario | |
| Chatham-Kent Health Alliance | Recruiting |
| Chatham, Ontario, Canada, N7L1B7 | |
| Principal Investigator: Ranjith Chandrasena, MD | |
| Centre for Neuropsychiatric Study | Recruiting |
| Markham, Ontario, Canada, L6B 1A1 | |
| Principal Investigator: Mark Berber, MD | |
| Credit Valley Medical Arts Centre | Recruiting |
| Mississauga, Ontario, Canada, L5M 4N4 | |
| Principal Investigator: Sunny Johnson, MD | |
| Centre for Addiction and Mental Health | Recruiting |
| Toronto, Ontario, Canada, M5T 1R8 | |
| Principal Investigator: Arun Ravindran, MD, PhD | |
| Sub-Investigator: Gaby Abraham, MD | |
| Sub-Investigator: Kevin Chopra, MD | |
| Sub-Investigator: Robert Cooke, MD | |
| Sub-Investigator: Robert Levitan, MD, MSc | |
| Principal Investigator: | Arun Ravindran, MD, PhD | Centre for Addiction and Mental Health |
More Information
| Responsible Party: | Arun Ravindran, Principal Investigator, Centre for Addiction and Mental Health |
| ClinicalTrials.gov Identifier: | NCT00688818 History of Changes |
| Other Study ID Numbers: | 183/2007 |
| Study First Received: | May 30, 2008 |
| Last Updated: | April 13, 2012 |
| 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 |
|
Anxiety Disorders Depressive Disorder Depression Dysthymic Disorder Panic Disorder Phobic Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Depressive Disorder, Major Mental Disorders Mood Disorders |
Behavioral Symptoms Quetiapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |