Quetiapine Fumarate (Seroquel) as Mono-Therapy or adjunct to lithium in the Treatment of Patients with Acute Mania in Bipolar Disorder - MANIA

Exclusion Criteria

• - Manic episode judged to be either:
• - the direct physiological consequence of a treatment or medical condition other than Bipolar disorder.
• - the direct physiological effect of a substance of abuse; intoxication with hallucinogens, inhalants, opioids, or phencyclidine and related substances.
• - the direct physiological effect of psychostimulant or antidepressant medication.
• - Evidence of clinically severe or active disease, or a clinical finding that is unstable or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication.
• - History of seizure disorder, except febrile convulsions.
• - Hospitalization period of 3 weeks or longer immediately prior to randomization for the index manic episode.
• - Known history of intolerance or hypersensitivity to quetiapine or lithium, or to any other component in the tablets/capsules.
• - Known lack of response to quetiapine or lithium, as judged by the investigator.
• - Use of antipsychotic medication or mood stabilizer other than quetiapine and lithium at the day of randomisation (to be tapered to discontinuation between the enrolment visit and randomisation).
• - Administration of a depot antipsychotic injection within 1 dosing interval (for the depot) before randomisation.
• - Use of clozapine within 28 days prior to randomisation.
• - Use of antidepressants during the enrolment period or within a period of 5 half-lives of the drug(s) prior to randomisation.
• - Continuous daily use of benzodiazepines in excess of 4 mg per day of lorazepam, or the equivalent, during 28 days prior to randomisation.
• - Use of drugs that induce or inhibit the hepatic metabolizing cytochrome 3A4 enzymes within 14 days before randomisation.
• - Receipt of electroconvulsive therapy (ECT) within 28 days prior to randomisation.
• - Clinically significant deviation from the reference range in clinical laboratory test results at enrolment, as judged by the investigator.
• - An absolute neutrophil count (ANC) of <1.5X109/L.
• - Treatment with quetiapine with a dosage of at least 50 mg/day at enrolment (Visit 1)
• - Liver function test AST or ALT 2 times as the upper normal limit.
• - A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the subject is being treated for hypothyroidism.
• - Known diagnosis of Diabetes Mellitus (DM) or fasting blood glucose level > the upper normal limit.
• - Risk of transmitting human immuno-deficiency virus (HIV) or hepatitis B via blood or other body fluids, as judged by the investigator.
• - ECG results considered to be clinically significant as determined by the investigator.
• - Conditions that could affect absorption and metabolism of study medication.
• - Patients who in the investigators opinion will require systematic psychotherapy (other than supportive psychotherapy) during the study period.
• - Participation in another clinical study or compassionate use programme within 28 days prior to randomisation, or longer if locally required.
• - Involvement in the planning and conduct of the study (applies to all AstraZeneca or staff at the investigational site).
• - Previous enrolment or randomisation of treatment in the present study.