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
Condition: Major Depression With Comorbid Anxiety Symptoms
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Quetiapine Fumarate (Seroquel®)
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Major Depression; Anxiety