A Six-month, Double-blind, Randomized, International, Multicenter Trial to Evaluate the Glucoregulatory Effects of Risperidone and Olanzapine in Subjects With Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Janssen, LP
- 入组人数
- 59
- 主要终点
- Change in the Disposition Index derived from the Frequently Sampled Intravenous Glucose Tolerance Test (which shows how the body regulates glucose)
研究概览
简要总结
The purpose of this study is to assess and compare how risperidone and olanzapine, two antipsychotic medications, affect the regulation of glucose (sugar) in the body.
详细描述
The newer antipsychotic medications risperidone and olanzapine effectively treat schizophrenia and related disorders, and they may cause fewer side effects than the older antipsychotic drugs do. However, some of the newer antipsychotic medications could have a negative effect on the regulation of blood glucose (sugar) in the body. This negative effect could make the patient gain weight and even develop diabetes mellitus. This randomized, double-blind study will assess and compare how risperidone and olanzapine affect the regulation of glucose in the body in patients with schizophrenia and schizoaffective disorder. Patients will be randomly assigned to receive risperidone (target oral dose of 6 milligrams per day) or olanzapine (target oral dose of 20 milligrams per day) for 6 months. Repeat laboratory measurements will be performed and questions will be asked of the patients to evaluate the safety and effectiveness of the drugs. The primary laboratory test used to assess the patient's regulation of blood glucose will be the Disposition Index derived from the Frequently Sampled Intravenous Glucose Tolerance Test. Risperidone 2 milligram oven-encapsulated tablets taken orally once a day for 6 months; olanzapine 5 milligram tablets taken orally once a day for 6 months
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia or related disorder
- •stable with respect to disease symptoms and other medical conditions
- •would benefit from this type of antipsychotic drug
- •if female, using birth control.
排除标准
- •Patients who are delirious, bipolar, severely mentally retarded, or suicidal
- •psychiatric diagnosis of disease unrelated to schizophrenia
- •presence of stroke, brain tumor, Parkinson's Disease, or diseases that affect blood glucose control
- •history of diabetes
- •long or recent history of taking risperidone, olanzapine, quetiapine, clozapine, or investigational drugs
- •recent history of unstable thyroid function
- •if female, not using birth control
- •abusing drugs or alcohol.
研究组 & 干预措施
001
Risperidone Target oral dose of 6 milligrams per day for for 6 months
干预措施: Risperidone (Drug)
002
Olanzapine Target oral dose of 20 milligrams per day for 6 months
干预措施: Olanzapine (Drug)
结局指标
主要结局
Change in the Disposition Index derived from the Frequently Sampled Intravenous Glucose Tolerance Test (which shows how the body regulates glucose)
时间窗: Up to 6 months
次要结局
- Changes in measurements of metabolism and glucose regulation; changes in results of tests and questionnaires evaluating the effectiveness and safety (including laboratory tests and anthropomatic measurements) of medications used to treat schizophrenia(Up to 6 months)