NCT01185743已完成4 期
Effect of Atypical Antipsychotics on Gene Expression in Soft Tissues of Healthy Subjects - A Placebo Controlled Randomised Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- gene expression profiling
研究概览
简要总结
Schizophrenia is a severe chronic and disabling mental disorder and is associated with a significant reduction in life expectancy. Atypical antipsychotic treatment compliance may be jeopardized because of drug induced weight gain and abnormalities in carbohydrate and lipid metabolism.
Aim: to gain data on drug related effects on gene expression and regulation with special regard to glucose metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, defined as absence of relevant diseases.
- •Caucasian.
- •Aged 18-45 years.
- •Body-Mass-Index (BMI): 18-25 kg/m
- •Signed informed consent.
- •No signs of impaired glucose tolerance as evaluated by Oral Glucose Tolerance Test (OGTT) before study inclusion during screening, normal total cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), triglycerides, normal function of the thyroid. No personal or family history (parents and siblings) of diabetes or other metabolic and relevant diseases as defined by the investigator.
- •No indication for psychiatric diseases assessed by structured clinical interview (Mini-International Neuropsychiatric Interview (MINI)).
排除标准
- •Personal or family history (parents and siblings) of diabetes or other metabolic diseases, relevant diseases as defined by the investigator.
- •History of hypertension, blood pressure > 140/90 at screening, cardiovascular disease.
- •Body mass index out of the range of <18 and >25 kg/m.
- •Human immunodeficiency virus (HIV) or Hepatitis B/C positive virology.
- •Allergy or hypersensitivity against olanzapine/ziprasidone or another excipient.
- •Contraindications against the use of the drug according to the Summary of Product Characteristics (SmPC).
- •Any drug intake 2 weeks prior to first study day.
- •History of excessive bleeding tendency/hemophilia.
- •Presence of relevant illness within the last 3 weeks.
- •Currently enrolled into an other clinical study with Investigational Medicinal Products (IMPs).
- •Last study participation less than 4 weeks.
- •Suspected non-compliance with study instructions and life-style requirements.
- •History of alcohol or drug abuse.
- •Blood/Plasma donation within 4 weeks prior to study day.
- •Previous exposure to antipsychotic drugs.
- •Nicotine consumption at time of enrolment (at least 3 months of non-smoking required).
研究组 & 干预措施
Sugar pill
Placebo Comparator
Sugar pill
干预措施: placebo (Drug)
olanzapine
Active Comparator
olanzapine
干预措施: ziprasidone (Drug)
olanzapine
Active Comparator
olanzapine
干预措施: olanzapine (Drug)
ziprasidone
Active Comparator
ziprasidone
干预措施: olanzapine (Drug)
ziprasidone
Active Comparator
ziprasidone
干预措施: ziprasidone (Drug)
结局指标
主要结局
gene expression profiling
时间窗: 10 days
To characterize and compare the gene expression profiles in human subcutaneous adipose and muscle tissue prior and after single dose of olanzapine, ziprasidone and placebo.
次要结局
未报告次要终点
研究者
Martin Bauer
MD
Medical University of Vienna
研究点 (1)
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