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临床试验/NCT00448630
NCT00448630已完成不适用

A MULTI-CENTER, NON-INVASIVE OBSERVATIONAL STUDY OF METABOLIC SYNDROME PARAMETERS IN SCHIZOPHRENIC PATIENTS USING ATYPICAL ANTIPSYCHOTICS

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.28 个研究点 分布在 1 个国家目标入组 328 人开始时间: 2007年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
328
试验地点
28
主要终点
Metabolic Syndrome Parameter Fasting Blood Sugar

研究概览

简要总结

The purpose of the study is to find and follow-up the metabolic syndrome parameters on patients administering atypical antipsychotics.

详细描述

Sampling Method Details: Group of patients using the same atypical anti-psychotic.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Female and male patients diagnosed as schizophrenia by the Diagnostic and Statistical Manual of Mental Disorders.
  • Age between 18-45 years
  • Patients who started atypical antipsychotic drug treatment or patients who switched from the previous conventional or atypical antipsychotic treatment to another atypical antipsychotic drug treatment by the decision of their physicians.

排除标准

  • Patients who are pregnant or considering pregnancy.

结局指标

主要结局

Metabolic Syndrome Parameter Fasting Blood Sugar

时间窗: Baseline, 1 Month, 4 Months

Iterative measurement of fasting blood sugar. Mean at time points.

Metabolic Syndrome Parameter Body Weight

时间窗: Baseline, 1 Month, 4 Months

Iterative measurement of body weight. Mean at time points.

Metabolic Syndrome Parameter Waist Circumference

时间窗: Baseline, 1 Month, 4 Months

Iterative measurement of waist circumference. Mean at timepoints.

Metabolic Syndrome Parameter Body Mass Index (BMI)

时间窗: Baseline, 1 Month, 4 Months

Iterative mean Body Mass Index at time points.

Metabolic Syndrome Parameter Total Cholesterol

时间窗: Baseline, 1 Month, 4 Months

Iterative measurement of total cholesterol. Mean at time points.

Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)

时间窗: Baseline, 1 Month, 4 Months

Iterative measurement of LDL. Mean at time points

Metabolic Syndrome Parameter High Density Lipoprotein (HDL)

时间窗: Baseline, 1 Month, 4 Months

Iterative measurement of HDL. Mean at time points

Metabolic Syndrome Parameter Triglycerides

时间窗: Baseline, 1 Month, 4 Months

Iterative measurement of triglycerides. Mean at time points

次要结局

  • Metabolic Syndrome Parameter Weight by Treatment Group(Baseline, 1 Month, 4 Months)
  • Metabolic Syndrome Parameter Triglycerides by Treatment Group(Baseline, 1 Month, 4 Months)
  • Metabolic Syndrome Parameter BMI by Treatment Group(Baseline, 1 Month, 4 Months)
  • Metabolic Syndrome Parameter Waist Circumference by Treatment Group(Baseline, 1 Month, 4 Months)

研究者

发起方
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (28)

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