A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study (STAR)

• The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 1 (Day<7) ] [ Designated as safety issue: No ]
• The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 2 (Day1) ] [ Designated as safety issue: No ]
• The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 3 (Day8) ] [ Designated as safety issue: No ]
• The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 4 (Day15) ] [ Designated as safety issue: No ]
• The changes in YMRS total score from baseline to Day 29 [ Time Frame: Visit 5 (Day29) ] [ Designated as safety issue: No ]

• The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 1 (Day<7) ] [ Designated as safety issue: No ]
• The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 2 (Day1) ] [ Designated as safety issue: No ]
• The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 4 (Day8) ] [ Designated as safety issue: No ]
• The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 5 (Day15) ] [ Designated as safety issue: No ]
• The percentage of patients with a =50% reduction from baseline in the YMRS total score at study endpoint [ Time Frame: Visit 6 (Day29) ] [ Designated as safety issue: No ]
• The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 1 (Day<7) ] [ Designated as safety issue: No ]
• The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 2 (Day1) ] [ Designated as safety issue: No ]
• The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 4 (Day8) ] [ Designated as safety issue: No ]
• The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 5 (Day15) ] [ Designated as safety issue: No ]
• The percentage of patients with YMRS remission (defined as a YMRS score = 12) at Day 29 [ Time Frame: Visit 6 (Day29) ] [ Designated as safety issue: No ]
• The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 1 (Day<7) ] [ Designated as safety issue: No ]
• The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 2 (Day1) ] [ Designated as safety issue: No ]
• The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 4 (Day8) ] [ Designated as safety issue: No ]
• The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 5 (Day15) ] [ Designated as safety issue: No ]
• The change from baseline to each assessment (observed cases) in the YMRS total score [ Time Frame: Visit 6 (Day29) ] [ Designated as safety issue: No ]

The primary objective of this study is to compare the efficacy of Seroquel XR monotherapy compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation of the changes from baseline in Young Mania Ratings Scale (YMRS) total score to Day 29 using the last observation carried forward method.

A comparison of the effectiveness of Seroquel XR and Seroquel XR plus lithium in patients with acute bipolar mania: An open-label, randomized, parallel groups, rater-blinded, 4 week, multicenter, comparative, phase 4 study.

• Drug: Quetiapine fumarate
  eXtended Release(XR) 50mg, 200mg, 300mg and/or 400mg tablet, oral, once daily in the evening, from assignment to the end of the study.
• Drug: lithium
  300mg tablet, oral

• Experimental: 1
  Seroquel XR tablet
  Intervention: Drug: Quetiapine fumarate
• Active Comparator: 2
  Seroquel XR + lithium
  Interventions:

  • Drug: Quetiapine fumarate
  • Drug: lithium

Inclusion Criteria:

• Female and/or male inpatients or outpatients, aged over 18 years and under 65 years
• Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
• YMRS total score =20 at enrollment and randomization (Day 1) Patients had a history of at least one manic episode that required hospitalization and/or treatment with a mood stabilizer or antipsychotic.
• Female patients must have a negative urine human chorionic gonadotropin (HCG) test at enrolment and must be using a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive

Exclusion Criteria:

• Pregnancy or lactation Meeting the criteria for any other (than bipolar disorder) DSM-IV Axis I diagnosis, concomitant organic mental disorder or mental retardation
• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
• Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization/baseline
• Known intolerance or hypersensitivity to, or lack of response to previous treatment with quetiapine fumarate or lithium