Study Evaluating the Clinical Benefit of SEROQUEL XR in Subjects With Schizophrenia

Inclusion Criteria:

• Provision of written informed consent before initiation of any study relatedprocedures.

• Male and female subjects aged 18 to 65 years, inclusive.

• Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of MentalDisorders, 4th edition (DSM-IV) criteria for any of the following: SchizophreniaDSM-IV, catatonic 295.20, disorganised 295.10, paranoid 295.30 and undifferentiated 295.90.

• Outpatient status.

• Subjects who in their own and/or in the Principal Investigator's opinion, considertheir ongoing antipsychotic treatment inadequate because of insufficient efficacy,poor tolerance, and/or non acceptability of their actual dosage regimen (eg. b.i.d,t.i.d, etc).

• Monotherapy with current antipsychotic for at least 7 days prior to initiatingtreatment (ie, cannot be on more than one antipsychotic during the 7 day period priorto initiating study medication). Note: Subjects on a b.i.d regimen of seroquel IR for 7 days prior to enrolment are eligible to participate in the study.

• Female subjects of childbearing potential must have a negative serum pregnancy test atenrolment and be willing to use a reliable method of birth control, ie, barriermethod, oral contraceptive, implant, dermal contraception, long-term injectablecontraceptive, intrauterine device, or tubal ligation during the study.

• Capable to make treatment decisions, including being able to understand and complywith the requirements of the study, and judged as such by the Principal Investigator.

• Be able to read and write either English or French at a grade 7 proficiency level.

Exclusion Criteria:

• First episode, drug naive schizophrenic subjects.

• Meeting the criteria for any other (than schizophrenia) DSM-IV Axis I diagnosis,concomitant organic mental disorder or mental retardation that in the opinion of thePrincipal Investigator may interfere with study conduct or interpretation.

• Substance/alcohol dependence or abuse at enrolment [except dependence in fullremission (>3 months) and except caffeine and nicotine dependence] as defined byDSM-IV criteria. A urine drug screen will be performed. The Principal Investigatorwill evaluate the results along with medical history to determine if the patient meetsDSM-IV criteria for substance abuse or dependence. However, a single urine toxicologyscreen for cocaine, heroin, methamphetamine or PCP will lead to exclusion.

• Subjects requiring treatment with another antipsychotic agent than investigationalproduct during study.

• Subjects on seroquel IR once daily.

• Known lack of response to clozapine or treatment with clozapine within 4 weeks priorto enrolment.

• Known intolerance to seroquel IR.

• Subjects requiring treatment with disallowed medication following enrolment into thestudy.

• Subjects requiring treatment for epilepsy.

• Subjects who pose an imminent risk of suicide or danger to themselves or others, asjudged by the Principal Investigator.

• Pregnancy or lactation.

• A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limitof the normal range of the laboratory used for sample analysis whether or not thepatient is being treated for hypothyroidism or hyperthyroidism.

• Use of a depot or long-acting injectable antipsychotic drug within 1 dosing intervalbefore Day 1 of treatment or during treatment.

• Use of drugs that induce or inhibit the hepatic metabolising cytochrome P450 3A4enzymes within 14 days of the screening assessment period (Day -7 to 0). See Table 5.

• History of idiopathic or drug-induced agranulocytosis.

• A QTc interval longer than 450 msec (calculated using the Fridericia correction forheart rate) or ECG considered to show cardiac abnormality at enrolment as determinedby a centrally located, experienced cardiologist, and confirmed by the PrincipalInvestigator as clinically significant.

• Evidence of clinically relevant disease (eg, renal, hepatic, autonomic, endocrine,hematologic or ophthalmologic impairment, significant coronary artery disease,congestive heart failure, cerebrovascular disease, viral hepatitis B or C, acquiredimmunodeficiency syndrome [AIDS] or cancer) or a clinical finding that is unstable orthat, in the opinion of the Principal Investigator, would be negatively affected bythe investigational product or that would affect the investigational product.

• Laboratory test results outside the reference range considered by the PrincipalInvestigator to be clinically significant and potentially interfere with the studyoutcome.

• A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:

• Unstable DM defined as HbA1c >8.5% at enrolment. Admitted to hospital fortreatment of DM or DM related illness in past 12 weeks.

• Not under care of physician responsible for patient's DM care.

• Physician responsible for patient's DM care has not indicated that patient's DMis controlled.

• Physician responsible for patient's DM care has not approved patient'sparticipation in the study.

• Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for thefour (4) weeks prior to randomisation. For thiazolidinediones (glitazones) thisperiod should not be less than 8 weeks.

• Taking insulin whose daily dose on one occasion in the past 4 weeks has been morethan 10% above or below their mean dose in the preceding 4 weeks. Note: If a diabetic patient meets one of these criteria the patient is to be excluded evenif the treating physician believes the patient is stable and can participate in the study.

• An absolute neutrophil count (ANC) of <1.5 x 109/L

• Inability to accommodate the visit schedule.

• History of non-compliance as judged by the Principal Investigator.

• Previous enrolment in the present study.

• Participation in another clinical study or compassionate use programme within 4 weeksof screening (Day -7 to 0).

• Involvement in the planning and conduct of the study (applies to both AstraZenecastaff or staff at the study site).