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

AstraZeneca1 site in 1 country331 target enrollmentMarch 2008

ConditionsSchizophrenia

DrugsQuetiapine Fumarate Extended- Release

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: AstraZeneca
Enrollment: 331
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

July 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

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.
•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.

Outcomes

Primary Outcomes

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

Time Frame: Baseline to 24 weeks (or end of study)

Proportional change in CGI-CB score The CGI-CB scale is used to evaluate investigator's global weighted impression of efficacy and interference of adverse events (AEs) from enrolment to every visit. The score ranges from 1 to 10. The lower the score the better the outcome, e.g.: a score of 1 means that there is marked therapeutic effect with no burden of AEs. A score of 10 signifies that the burden of AEs outweighs the therapeutic effect, or no therapeutic effect with high burden of AEs. A change score for each subject will be calculated by subtracting the baseline score from the visit score.

Secondary Outcomes

Change in Clinical Global Impression-Clinical Benefit (CGI-CB) Score(Baseline to 24 weeks)
Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Positive Scale Score(Baseline to 24 weeks)
Change in Barnes Akathisia Rating Scale (BARS)(Baseline to 24 weeks)
Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score(Baseline to 24 weeks)
Change in Global Assessment Scale (GAS)(Baseline to 24 weeks)
Change in Clinical Global Impression-Severity (CGI-S) Scale(Baseline to 24 weeks)
Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Negative Scale Score(Baseline to 24 weeks)
Change in Clinical Global Impression-Improvement (CGI-I) Scale(Day 7 - week 24)
Change in Social and Occupational Functioning Assessment Scale (SOFAS)(Baseline to 24 weeks)
Change in Safety Measure: Simpson-Angus Scale (SAS)(Baseline to 24 weeks)