study evaluating the clinical benefit of seroquel xr in subjects with schizophrenia

Conditions: Schizophrenia

Summary: a multicentre, open-label, prospective long-term study evaluating the clinical benefit and effectiveness of seroquel xr® (quetiapine fumarate extended-release tablets) in subjects with schizophrenia.


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).

Keywords: seroquel schizophrenia extended release