Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Quetiapine Fumarate (SEROQUEL) Extended Release; Placebo
Intervention description: Quetiapine fumarate extended release(XR) will be administered orally, once daily in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.; Placebo matching quetiapine extended release(XR) 50 mg, 200 mg, and 300 mg tablets will be orally administered once daily, in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 361.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar Depression; Mental disease,

Summary:

      The primary objective of this study is to evaluate the superior efficacy of quetiapine
      extended release(XR) mono-therapy, administered once daily compared to placebo, in the
      treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Male and female patients, aged 18 to 65 years, inclusive.

          -  Meets Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV)
             criteria for bipolar disorder I or bipolar II, most recent episode depressed (296.5x
             and 296.89x).

          -  Hamilton Rating Scale for Depression (HAM-D) (17-item) total score of ≥ 20 and HAM-D
             item 1 (depressed mood) score ≥ 2 at enrolment and randomisation.

          -  Patients must be able to understand and comply with the requirements of the study,as
             judged by the Investigator

        Exclusion Criteria:

          -  Patients with a current Diagnostic and Statistical Manual of Mental Disorders - 4th
             Edition (DSM-IV) diagnosis other than bipolar disorder

          -  Patients whose Young Mania Rating Scale (YMRS) total score >12 at enrolment and
             randomisation.

          -  Patients with >8 mood episodes during the past 12 months at enrolment.

          -  Patients whose current episode of depression exceeds 12 months or is less than 4 weeks
             from enrolment.

          -  Patients with a history of non-response to an adequate treatment (6 weeks) with more
             than 2 classes of antidepressants during their current episode.

          -  Alcohol or other substance dependence or abuse as defined by Diagnostic and
             Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria at enrolment
             that is not in extended full or extended partial remission (12 months or longer),
             except caffeine and nicotine dependence.

          -  Patients who, in the Investigator's judgment, pose a current serious suicidal or
             homicidal risk, have a Hamilton Rating Scale for Depression (HAM-D) item 3 score ≥ 3,
             or have made a suicide attempt within the past 6 months.