NCT00090012已完成4 期
The Comparison of Efficacy and Safety of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 25
- 主要终点
- The primary objective of this study is to assess the treatment difference in time to relapse while on olanzapine 7.5-20 mg/day versus quetiapine 300-800 mg/day in the treatment of obese or overweight patients
研究概览
简要总结
The purposes of this study are to determine:
- The effectiveness of olanzapine as compared to quetiapine in treating and preventing the recurrence of a variety of symptoms of schizophrenia and schizoaffective disorder in patients who are obese or overweight.
- The safety of olanzapine as compared to quetiapine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •You must be 18-75 years of age and be diagnosed with schizophrenia or schizoaffective disorder
- •You must be able to visit the doctor's office thirteen (13) times over a twenty-six (26) week period
排除标准
- •You are a woman and are pregnant or breastfeeding
- •You have an acute or unstable medical illness, such as heart, liver, or kidney disease, or you have a seizure disorder. (Note: If you are uncertain about a particular condition, please discuss it with your physician.)
- •You have a history of allergic reaction or intolerance to olanzapine or quetiapine
结局指标
主要结局
The primary objective of this study is to assess the treatment difference in time to relapse while on olanzapine 7.5-20 mg/day versus quetiapine 300-800 mg/day in the treatment of obese or overweight patients
with schizophrenia or schizoaffective disorder. Relapse is defined as the occurrence of at least one of the following three conditions:
Hospitalization for psychiatric reasons after Visit 2, or
20% worsening on the Positive and Negative Syndrome Sale (PANSS) Total and an increase in level of care, as compared to Visit 2, or
20% worsening on the PANSS Total compared to Visit 2 and worsening of CGI-S by at least one level compared to Visit 2 and CGI-S level of at least 4 (moderately ill).
次要结局
- To assess within and between group changes in metabolic parameters including fasting glucose, hemoglobin Alc, lipids, and insulin
- To assess within and between group changes in weight, waist circumference, BMI, appetite, and prevalence of patients meeting criteria for the metabolic syndrome
- To assess within and between group changes in metabolic parameters (fasting glucose and lipids, and hemoglobin A1c) in a sub-group of patients with pre-existing diabetes prior to study entry
- To assess the effect of olanzapine versus quetiapine on time to discontinuation for any reason, or lack of efficacy or worsening of psychiatric syndromes
- To assess the efficacy of olanzapine versus quetiapine in improving psychopathology of schizophrenia as measured by a mean change from baseline on the PANSS and the Clinical Global Impression-Severity (CGI-S)
- Scale as well as by absolute score of CGI-I (Improvement Scale)
- To assess the efficacy of olanzapine versus quetiapine in improving depressive symptoms as measured by a mean change from baseline on the montgomery-Asberg Depression Rating Scale (MADRS)
- To assess the efficacy of olanzapine versus quetiapine in improving patients' general well being and overall level of functioning as measured by the Short Form 36 Health Survey (SF-36), the Patient Global Impression (PGI)Scale,
- and the Global Assessment of Functioning (GAF) Scale
- To assess patients' opinions on the treatment with olanzapine versus quetiapine as measured by the Drug Attitude Inventory (DAI-10) Scale
- To compare the utilization of medical resources between patients treated with olanzapine or quetiapine
- To assess the safety of olanzapine and quetiapine as determined by:
- Treatment-emergent adverse events
- Vital signs and fasting laboratory analytes
- Extrapyramidal symptoms as measured by the Modified Simpson-Angus Scale, the Barnes Akathisia Rating Scale, and the Abnormal Involuntary Movement Scale (AIMS)
- A sensitivity analysis will be performed on two randomly chosen subsamples of the overall patient population by analyzing the primary objective respectively
研究者
研究点 (25)
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