Study Evaluating the Clinical Benefit of SEROQUEL XR in Subjects With Schizophrenia
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Quetiapine Fumarate Extended- Release (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Pierre Chue, MD, Principal Investigator, Affiliation: University of Alberta Willie Early, MD, Study Chair, Affiliation: AstraZeneca
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.
Clinical Details
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: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Subjects With Improved Clinical Benefit From Assessment of Clinical Global Impression-Clinical Benefit (CGI-CB) Scale From Baseline to Week 24 or End of Study
Secondary outcome: Change in Clinical Global Impression-Clinical Benefit (CGI-CB) ScoreChange in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Positive Scale Score Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Negative Scale Score Change in Global Assessment Scale (GAS) Change in Clinical Global Impression-Severity (CGI-S) Scale Change in Clinical Global Impression-Improvement (CGI-I) Scale Change in Social and Occupational Functioning Assessment Scale (SOFAS) Change in Safety Measure: Simpson-Angus Scale (SAS) Change in Barnes Akathisia Rating Scale (BARS)
Eligibility
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).
Locations and Contacts
Research Site, Quebec, Canada
Research Site, HK, Hong Kong
Research Site, Calgary, Alberta, Canada
Research Site, Claresholm, Alberta, Canada
Research Site, Red Deer, Alberta, Canada
Research Site, Garran, Australian Capital Territory, Australia
Research Site, Vancouver, British Columbia, Canada
Research Site, Victoria, British Columbia, Canada
Research Site, Seoul, Korea, Korea, Republic of
Research Site, Miramichi, New Brunswick, Canada
Research Site, Newcastle, New South Wales, Australia
Research Site, St John's, Newfoundland and Labrador, Canada
Research Site, St. John's, Newfoundland and Labrador, Canada
Research Site, Sydney, Nova Scotia, Canada
Research Site, Belleville, Ontario, Canada
Research Site, Brantford, Ontario, Canada
Research Site, Chatham, Ontario, Canada
Research Site, Cornwall, Ontario, Canada
Research Site, London, Ontario, Canada
Research Site, Markham, Ontario, Canada
Research Site, Mississauga, Ontario, Canada
Research Site, Newmarket, Ontario, Canada
Research Site, Oakville, Ontario, Canada
Research Site, Orleans, Ontario, Canada
Research Site, Sudbury, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Windsor, Ontario, Canada
Research Site, Gatineau, Quebec, Canada
Research Site, Greenfield Park, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Rouyn-noranda, Quebec, Canada
Research Site, Verdun, Quebec, Canada
Research Site, Brisbane, Queensland, Australia
Research Site, Meadowbrook, Queensland, Australia
Research Site, Prince Albert, Saskatchewan, Canada
Research Site, Saskatoon, Saskatchewan, Canada
Research Site, Dandenong, Victoria, Australia
Additional Information
Starting date: March 2008
Last updated: June 22, 2012
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