NCT00640601已完成3 期
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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 331
- 试验地点
- 37
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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).
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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)
研究者
研究点 (37)
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