The Effects of Quetiapine XR on Cognition, Mood and Anxiety Symptoms in SSRI-Resistant Unipolar Depression
Condition: Unipolar Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Recently published work has examined the effects of "atypical antipsychotics" in
      SSRI-treatment resistant patients. In these studies, patients with unipolar depression who
      were treated with SSRI's, but not responsive to treatment after 4 or more weeks, were
      supplemented with an atypical. The atypical antipsychotics were found to diminish depression
      symptoms, as well as benefit sleep quality.

      We propose a similar study with Quetiapine XR, focusing on thinking processes, mood and
      anxiety. Patients with depression who are SSRI treatment resistant will be treated with
      Quetiapine. Cognition will be evaluated in the UBC Mood Disorders Clinic two times: first
      before Quetiapine addition, then after 8 weeks. Depression symptoms and other measurements
      will be done at the 9 time points: before Quetiapine, and each week after treatment has
      begun.

      The primary purpose of this study is to evaluate the superiority of Quetiapine XR compared to
      placebo as augmentation therapy in treatment of anxiety and depressive symptoms in
      SSRI-nonresponsive unipolar patients. Secondarily, we would like to evaluate the safety and
      tolerability of quetiapine as augmentation therapy in SSRI-nonresponsive unipolar patients.
    

Detailed description: 
      This is a double-blind, placebo-controlled study, in which patients will receive treatment of
      Quetiapine XR for 8 weeks. All patients will receive Quetiapine XR at an initial dose of
      50mg/day to be increased incrementally (dose of 50mg/day 2 and 150mg/day 3) to achieve a
      target dose of 300 mg/day by day 4. Tablets will be self-administered early each night.
      Patient's results will be compared to their own baseline measurements, in a double-blind
      fashion.

      Recruited patients will be evaluated at nine time points: a baseline prior to treatment (t =
      -7 days), an assessment one week after treatment has begun (t = 7 days), two weeks after (t =
      14 days), three weeks after (t = 21 days), four weeks after (t = 28 days), five weeks after
      (t = 35 days), six weeks after (t = 42 days), seven weeks after (t = 49 days) and after 8
      weeks of treatment (t = 56 days). Evaluation of cognition, mood and anxiety, will be done
      blind to which time point is being measured.

      Basic blood work (fasting blood glucose, lipid screen including triglycerides, urea and
      electrolytes, cytokines and neuroimmune markers) will performed on each patient both at
      baseline (t = -7 days) and at t = 56 days. At 4 weeks, blood sample will be taken for fasting
      plasma glucose, HbA1c and transaminases. At baseline (-7 days) and completion (56 days) a
      battery of neurocognitive-impairment tests (see Appendix A) will be administered. In
      addition, the Hamilton Rating Scale for Depression (21-ITEM HAM-D GRID), Montgomery -Asberg
      Depression Rating Scale (MADRS), Hamilton Ratings Scale for Anxiety (HAM-A), the UKU Side
      Effect Rating Scale, and the Quality of Life Enjoyment and Satisfaction Questionnaire
      (Q-LES-Q) will also be assessed by the research team.
    

Intervention name(s): Quetiapine XR
Intervention type(s): Drug
Intervention description(s): All patients will receive Quetiapine XR at an initial dose of 50mg/day to be increased incrementally (dose of 50mg/day 2 and 150mg/day 3) to achieve a target dose of 300 mg/day by day 4. Tablets will be self-administered early each night.
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; SSRI; Atypical Antipsychotic; Cognition; Mood; Quality of Life