Quetiapine Extended Release (XR) Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder
Condition: Major Depressive Disorder; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Quetiapine XR; Placebo
Intervention description: Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day; Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary objective is to test the hypothesis that quetiapine XR (Extended Release)
      monotherapy or adjunctive therapy to antidepressant is superior to placebo monotherapy or
      placebo adjunctive therapy to antidepressant(s) in the acute treatment of depression symptoms
      in patients with MDD and comorbid GAD. The secondary objectives are to test the hypotheses
      that quetiapine XR is superior to placebo in the reduction of anxiety symptoms in patients
      with major depressive disorder and comorbid generalized anxiety disorder, the improvement of
      the quality of sleep in patients with major depressive disorder and comorbid generalized
      anxiety disorder and the improvement of the quality of life in patients with major depressive
      disorder and comorbid generalized anxiety disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide informed consent before beginning any study-specific procedures

          -  Male and female patients at least 18 years of age - 70 years of age

          -  Meets Diagnostic and Statistical Manual IV (DSM-IV) criteria for MDD, currently
             depressed

          -  DSM-IV diagnosis of current GAD

          -  Women with reproductive potential must have a negative urine pregnancy test

        Exclusion Criteria:

          -  Patients who have had a current episode of depression for less than 4 weeks from
             enrollment

          -  Patients who have been treated for their current depressive episode for more than 3
             weeks with Quetiapine therapy 50 mg/day

          -  Patients currently taking antidepressants known to cause somnolence/sedation such as
             mirtazapine or unable to wean off current antidepressant if they choose monotherapy

          -  Patients who meet DSM-IV criteria for substance dependence confirmed by the Substance
             Use Disorder Module of the Structured Clinical Interview for DSM-IV (SCID), for any
             substance except for caffeine and nicotine, with substance abuse within last 3 months
             or substance dependence within last 6 months;

          -  Concurrent obsessive-compulsive disorder

          -  Patients with a history of clinically significant cardiac, renal, neurologic,
             cerebrovascular, metabolic, or pulmonary disease, or other disease or clinical finding
             that is unstable or that, in the opinion of the investigator, would be negatively
             effected by trial medication or that would effect trial medication

          -  A patient with diabetes mellitus (DM) fulfilling one of the following criteria:

               -  Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) > 8.5%

               -  Admitted to hospital for treatment of DM or DM related illness within the past 12
                  weeks

               -  Not under physician care for DM

               -  Physician responsible for patient's DM care has not indicated that the patient's
                  DM is controlled

               -  Physician responsible for patient's DM care has not approved the patient's
                  participation in the study

               -  Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4
                  weeks before randomization (for thiazolidinediones (glitazones) this period
                  should not be less than 8 weeks before randomization)

               -  Taking insulin whose daily dose on one occasion in the past 4 weeks has been more
                  than 10% above or below their mean dose in the preceding 4 weeks

        Note: If a patient with DM meets one of these criteria, the patient is to be excluded even
        if the treating physician believes that the patient is stable and can participate in the
        study. A patient could be enrolled at a later time if DM is stabilized.