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

Inclusion Criteria

• 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