Clinical trial NCT00640601 (phase 3, status: completed)
Conditions: schizophrenia
ICD codes: F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9
Drugs: quetiapine fumarate extended- release
SMILES: OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12
Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent before initiation of any study related
             procedures.

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

          -  Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental
             Disorders, 4th edition (DSM-IV) criteria for any of the following: Schizophrenia
             DSM-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, consider
             their 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 initiating
             treatment (ie, cannot be on more than one antipsychotic during the 7 day period prior
             to 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 at
             enrolment and be willing to use a reliable method of birth control, ie, barrier
             method, oral contraceptive, implant, dermal contraception, long-term injectable
             contraceptive, intrauterine device, or tubal ligation during the study.

          -  Capable to make treatment decisions, including being able to understand and comply
             with 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 the
             Principal Investigator may interfere with study conduct or interpretation.

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

          -  Subjects requiring treatment with another antipsychotic agent than investigational
             product during study.

          -  Subjects on seroquel IR once daily.

          -  Known lack of response to clozapine or treatment with clozapine within 4 weeks prior
             to enrolment.

          -  Known intolerance to seroquel IR.

          -  Subjects requiring treatment with disallowed medication following enrolment into the
             study.

          -  Subjects requiring treatment for epilepsy.

          -  Subjects who pose an imminent risk of suicide or danger to themselves or others, as
             judged by the Principal Investigator.

          -  Pregnancy or lactation.

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

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

          -  Use of drugs that induce or inhibit the hepatic metabolising cytochrome P450 3A4
             enzymes 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 for
             heart rate) or ECG considered to show cardiac abnormality at enrolment as determined
             by a centrally located, experienced cardiologist, and confirmed by the Principal
             Investigator 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, acquired
             immunodeficiency syndrome [AIDS] or cancer) or a clinical finding that is unstable or
             that, in the opinion of the Principal Investigator, would be negatively affected by
             the investigational product or that would affect the investigational product.

          -  Laboratory test results outside the reference range considered by the Principal
             Investigator to be clinically significant and potentially interfere with the study
             outcome.

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

               -  Unstable DM defined as HbA1c >8.5% at enrolment. Admitted to hospital for
                  treatment 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 DM
                  is controlled.

               -  Physician responsible for patient's DM care has not approved patient's
                  participation in the study.

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

               -  Taking insulin whose daily dose on one occasion in the past 4 weeks has been more
                  than 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 even
        if 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 weeks
             of screening (Day -7 to 0).

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