Cerebral Mechanism Involved in Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics (IIT)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- fMRI (functional magnetic resonance imaging with appetizing films)
研究概览
简要总结
The purpose of this study is to understand, with the use of functional magnetic resonance imaging, the neural correlates involved in appetite control and the mechanism of weight gain in patients with schizophrenia treated with atypical antipsychotics. We hypothesize that a difference in cerebral activations between weight gaining and non-weight gaining patients will be detected after four months of treatment with olanzapine.
详细描述
Atypical antipsychotics (AAP) have revolutionize treatment of schizophrenia. They are considered to be more effective in reducing positive and negative symptoms and in improving cognitive deficits. They cause less extrapyramidal symptoms and tardive dyskinesia than typical antipsychotics. They still have a lot of important side effects like sedation, metabolic syndrome and weight gain. These effects could lead to obesity, type II diabetes and cardiovascular diseases, particularly for schizophrenia patients because they are already at an increased risk for these complications. Moreover, an increase in weight gain has been demonstrate to exacerbate negative symptoms and can lead to non compliance with a consequent risk of relapse. It also can create an additional social disadvantage for schizophrenia patients and decrease their quality of life. The weight gain will result, in part from an increased food intake (and probably an increased appetite) and from a decreased energy expenditure.
The purpose of this study is to understand the cerebral mechanisms of appetite in patients with schizophrenia treated with atypical antipsychotics to prevent or treat their weight gain.
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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with schizophrenia (DMS-IV)
- •18 to 60 years old
- •Right handed
- •Begin a treatment with olanzapine and had not received it for at leat 6 months
- •Other medication accepted (except antipsychotic)
排除标准
- •concomitant axis-I or axis-II disorders
- •unstable medical condition
- •Concomitant antipsychotic medications
研究组 & 干预措施
Olanzapine
干预措施: Olanzapine (Drug)
结局指标
主要结局
fMRI (functional magnetic resonance imaging with appetizing films)
时间窗: 16 weeks after beginning of Olanzapine treatment
Weight
时间窗: 16 weeks after beginning of Olanzapine treatment
次要结局
- Abdominal circumference(16 weeks after beginning of Olanzapine treatment)
- Fasting glucose(16 weeks after beginning of Olanzapine treatment)
- Insulin(16 weeks after beginning of Olanzapine treatment)
- Leptin(16 weeks after beginning of Olanzapine treatment)
- Ghrelin(16 weeks after beginning of Olanzapine treatment)
- Endogenous cannabinoids(16 weeks after beginning of Olanzapine treatment)
- Lipid profile(16 weeks after beginning of Olanzapine treatment)
- PANSS (Positive and negative syndrome scale)(16 weeks after beginning of Olanzapine treatment)
- CDSS (Calgary Depression scale for schizophrenia)(16 weeks after beginning of Olanzapine treatment)
- Three factors eating questionnaire(16 weeks after beginning of Olanzapine treatment)
- Fagerstrom test for nicotine dependence(16 weeks after beginning of Olanzapine treatment)
- Adult ADHD (attention deficit hyperactivity disorder) self report scale(16 weeks after beginning of Olanzapine treatment)
- Age(16 weeks after beginning of Olanzapine treatment)
- Sexe(16 weeks after beginning of Olanzapine treatment)
- Weight(16 weeks after beginning of Olanzapine treatment)
- Number and times of hospitalization(16 weeks after beginning of Olanzapine treatment)
- Blood pressure(16 weeks after beginning of Olanzapine treatment)
- Prolactin(16 weeks after beginning of Olanzapine treatment)
- Onset of disease(16 weeks after beginning of Olanzapine treatment)
- Level of education(16 weeks after beginning of Olanzapine treatment)