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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine and existing psychotropics | Experimental |
| |
| Placebo and existing psychotropics | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale (HAMD-17) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Anxiety Scale | Baseline, 6 weeks and 12 weeks | |
| Quality of Life Enjoyment and Satisfaction Scale | Baseline, 6 weeks and 12 weeks | |
| Penn State Worry Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arun Ravindran, MD, PhD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chatham-Kent Health Alliance | Chatham | Ontario | N7L1B7 | Canada | ||
| Centre for Neuropsychiatric Study |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35324094 | Derived | Ravindran N, McKay M, Paric A, Johnson S, Chandrasena R, Abraham G, Ravindran AV. Randomized, Placebo-Controlled Effectiveness Study of Quetiapine XR in Comorbid Depressive and Anxiety Disorders. J Clin Psychiatry. 2022 Mar 21;83(3):21m14096. doi: 10.4088/JCP.21m14096. |
| Label | URL |
|---|---|
| Information about research at the Centre for Addiction and Mental Health | View source |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019263 | Dysthymic Disorder |
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| D000072861 | Phobia, Social |
| D016584 | Panic Disorder |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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|
| Placebo | Drug | 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. |
|
| Baseline, 6 weeks and 12 weeks |
| Panic Disorder Severity Scale | Baseline, 6 weeks and 12 weeks |
| Leibowitz Social Anxiety Scale | Baseline, 6 weeks and 12 weeks |
| Post-traumatic Diagnostic Scale | Baseline, 6 weeks and 12 weeks |
| Clinical Global Impression Scale | Baseline, 6 weeks and 12 weeks |
| Markham |
| Ontario |
| L6B 1A1 |
| Canada |
| Credit Valley Medical Arts Centre | Mississauga | Ontario | L5M 4N4 | Canada |
| Centre for Addiction and Mental Health | Toronto | Ontario | M5T 1R8 | Canada |
| D040921 |
| Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |