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

Condition(s) targeted: Schizophrenia

Intervention: Quetiapine Fumarate Extended- Release (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Pierre Chue, MD, Principal Investigator, Affiliation: University of Alberta
Svante Nyberg, MD, Study Chair, Affiliation: AstraZeneca R&DSodertalje, Sweden

Overall contact:
Canada Clinical Study Information, Phone: (905) 804-5841, Email: duncan.jewell@astrazeneca.com

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.

Official title: 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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome: Proportion of patients with improved clinical benefit from assessment of Clinical Global Impression - Clinical Benefit Scale (CGI-CB) scale.

Secondary outcome:

Change in Clinical Global Impression - Clinical Benefit Scale (CGI-CB) score

Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS)total score for Schizophrenia

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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).

Canada Clinical Study Information, Phone: (905) 804-5841, Email: duncan.jewell@astrazeneca.com

Research Site, QUEBEC, Canada; Recruiting

Research Site, SEOUL, Korea, Republic of; Not yet recruiting

Research Site, CALGARY, Alberta, Canada; Recruiting

Research Site, CLARESHOLM, Alberta, Canada; Recruiting

Research Site, RED DEER, Alberta, Canada; Not yet recruiting

Research Site, GARRAN, Australian Capital Territory, Australia; Not yet recruiting

Research Site, VANCOUVER, British Columbia, Canada; Recruiting

Research Site, VICTORIA, British Columbia, Canada; Recruiting

Research Site, BATHURST, New Brunswick, Canada; Not yet recruiting

Research Site, Miramichi, New Brunswick, Canada; Not yet recruiting

Research Site, Blacktown, New South Wales, Australia; Not yet recruiting

Research Site, Newcastle, New South Wales, Australia; Not yet recruiting

Research Site, ST JOHN'S, Newfoundland and Labrador, Canada; Recruiting

Research Site, SYDNEY, Nova Scotia, Canada; Active, not recruiting

Research Site, BELLEVILLE, Ontario, Canada; Recruiting

Research Site, BRANTFORD, Ontario, Canada; Recruiting

Research Site, CHATHAM, Ontario, Canada; Recruiting

Research Site, KINGSTON, Ontario, Canada; Not yet recruiting

Research Site, LONDON, Ontario, Canada; Recruiting

Research Site, MARKHAM, Ontario, Canada; Recruiting

Research Site, MISSISSAUGA, Ontario, Canada; Recruiting

Research Site, NEWMARKET, Ontario, Canada; Recruiting

Research Site, OAKVILLE, Ontario, Canada; Recruiting

Research Site, ORLEANS, Ontario, Canada; Recruiting

Research Site, SUDBURY, Ontario, Canada; Recruiting

Research Site, TORONTO, Ontario, Canada; Recruiting

Research Site, Cornwall, Ontario, Canada; Not yet recruiting

Research Site, Windsor, Ontario, Canada; Not yet recruiting

Research Site, GATINEAU, Quebec, Canada; Recruiting

Research Site, GREENFIELD PARK, Quebec, Canada; Not yet recruiting

Research Site, MONTREAL, Quebec, Canada; Recruiting

Research Site, ROUYN-NORANDA, Quebec, Canada; Recruiting

Research Site, VERDUN, Quebec, Canada; Recruiting

Research Site, BRISBANE, Queensland, Australia; Not yet recruiting

Research Site, Meadowbrook, Queensland, Australia; Not yet recruiting

Research Site, PRINCE ALBERT, Saskatchewan, Canada; Not yet recruiting

Research Site, SASKATOON, Saskatchewan, Canada; Recruiting

Research Site, DANDENONG, Victoria, Australia; Not yet recruiting

Research Site, Ballarat, Victoria, Australia; Not yet recruiting

Starting date: March 2008
Ending date: April 2010
Last updated: June 4, 2009