A Double Blind, Randomized Placebo Controlled Study of the Efficacy, Safety and of Quetiapine Fumarate (Seroquel®) as Potentiation SSRI's, and SNRI's Treatment in Major Depression With Anxiety
Major depression occurs with generalized anxiety disorder and panic disorder in up to 60% of psychiatric and primary care patients.(1) An estimated 85% of adults with depression experience significant symptoms of anxiety and 58% have a diagnosable anxiety disorder during their lifetime.(2) Numerous studies have shown that symptoms of anxiety are frequent in patients with major depressive disorder, and the presence of anxiety symptoms is associated with a more severe and chronic course.(3,4) This comorbidity has been associated with a greater severity of depression, poorer psychosocial functioning, poorer treatment response and higher risk for suicide.
The data suggests that novel antipsychotics have antidepressant and anxiolytic effects. This study will explore the impact of this effect in patients with major depression and comorbid anxiety symptoms.
This study offers the possibility of systematically reviewing the role of quetiapine in depression with anxiety. If the combination of an SSRI or SNRI and quetiapine proves to effective it could offer a viable alternative to widespread benzodiazepine use.
|Major Depression With Comorbid Anxiety Symptoms||Drug: Quetiapine Fumarate (Seroquel®)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Double Blind, Randomized Placebo Controlled Study of the Efficacy, Safety and Tolerability of Immediate-Release Formulation of Quetiapine Fumarate as Potentiation of Selective Serotonin Reuptake Inhibitors, and Serotonin Norepinephrine Reuptake Inhibitors Treatment in Major Depression With Comorbid Anxiety Symptoms|
- To compare the efficacy of quetiapine versus placebo over 8 weeks as an adjunctive agent for unipolar non-psychotic adult outpatients on SSRI or SNRI therapy with residual symptoms of depression and comorbid anxiety symptoms. This will be measured by the
- 1. Hamilton Depression Scale (HAM-D) total score,
- 2. Hamilton Anxiety Scale (HAM-A) total score
|Study Start Date:||November 2003|
|Estimated Study Completion Date:||April 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00229645
|Canada, British Columbia|
|Dr. A. McIntyre|
|Penticton, British Columbia, Canada, V2A 3G6|
|Principal Investigator:||Alexander W McIntyre, FRCPC||Dr Alexander McIntyre Inc.|