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®)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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|
This is a double blind study where patients will be involved and be under treatment for a period of 8 weeks. The initial evaluation will include rating scales measuring depression, anxiety, severity of illness, overall functioning, pregnancy test and clinical evaluations. Patients being treated with a SSRI or SNRI for at least 6 weeks, at therapeutic doses (see table 1.), who still have a HAM-D score of 18 or more, will be randomly assigned to treatment, either with Quetiapine, or Placebo. Patients in the active group will be titrated on a fixed schedule of 50 mg at night for 7 days, 100 mg at night for 7 days, then 200 mg at night for 7 days. After this the dose will be titrated upwards to a maximum of 600mg at night at the discretion of the investigator, using patient tolerance and response as guidelines over the duration of the trial. 200mg is in the range of the average dose in large trials of naturalistic clinical use of quetiapine and is actually much slower than the titration schedule on the package label. Patients that can not tolerate 200mg/day will be withdrawn from the study. Patients should have tried a minimum of 400mg /day before being withdrawn because of lack of efficacy. This dose will remain steady until week 8. Rating scales will be repeated every week during the first 2 weeks, and every 2 weeks up to the end of the study at week 8.
|Canada, British Columbia|
|Dr. A. McIntyre|
|Penticton, British Columbia, Canada, V2A 3G6|
|Principal Investigator:||Alexander W McIntyre, FRCPC||Dr Alexander McIntyre Inc.|