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临床试验/NCT00956189
NCT00956189已完成不适用

Easy Identification, Treatment Response Prediction, and Molecular Mechanism Exploration of Antipsychotic-related Metabolic Syndrome

National Taiwan University Hospital3 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
3
主要终点
Metabolic profile

研究概览

简要总结

The investigators developed an easy identification model to identify metabolic syndrome in patients with schizophrenia or schizoaffective disorder who received treatment of clozapine, olanzapine, or risperidone. The accuracy of the investigators' models showed well. In the study, the investigators aim to (1) to examine whether the developed identification models can be generalized to patients taking other antipsychotics or patients with other diagnoses; (2) to develop an easy risk score and validate it; (3) to switch antipsychotics to amisulpride or aripiprazole for those with metabolic syndrome, and compare the changes of metabolic parameters including adiponectin, and analyze their association with genetic variants, demography, and clinical variables; (4) to establish models using artificial neural network and statistic method to predict metabolic response after a switch to amisulpride or aripiprazole; (5) to investigate the effect of antipsychotics on adiponectin gene expression and secretion during the differentiation process of 3T3L1 adipocytes.

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, mood disorders, or anxiety disorders based on DSM-IV-TR criteria.
  • Age at least 20 years old.
  • The current antipsychotic drugs have been used for at least 3 months before evaluation.
  • Psychiatrically stable with Clinical Global Impression of Severity scale (CGI-S) not greater than 5

排除标准

  • Severe uncontrolled medical illnesses, including cardiovascular, hepatic, renal and metabolic diseases (eg. cancer, poor-control hypertension, diabetes mellitus, and other metabolic diseases).
  • Organic mental or neurological disorder, substance abuse or dependence (alcohol, amphetamine, heroin).
  • Pregnant or breast-feeding women.
  • Patients from Yuli Veterans Hospital, who attended our previous study of identification model.
  • Stage II for switch response:
  • Inclusion Criteria:
  • The same as Stage I criteria.
  • Fulfill the metabolic syndrome criteria.
  • Exclusion Criteria:
  • The same as Stage I criteria except the 4th item.
  • Treated with depot form of antipsychotics.

研究组 & 干预措施

Amisulpride

Experimental

A slow plateau cross-titration method was used to switch original antipsychotics to Amisulpride.

干预措施: amisulpride (Drug)

Aripiprazole

Experimental

A slow plateau cross-titration method was used to switch original antipsychotics to Aripiprazole.

干预措施: aripiprazole (Drug)

结局指标

主要结局

Metabolic profile

时间窗: half/one year

次要结局

  • Clinical efficacy(half/one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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