Easy Identification, Treatment Response Prediction, and Molecular Mechanism Exploration of Antipsychotic-related Metabolic Syndrome
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
- 否
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
A slow plateau cross-titration method was used to switch original antipsychotics to Amisulpride.
干预措施: amisulpride (Drug)
Aripiprazole
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)
