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临床试验/NCT00190749
NCT00190749已完成4 期

Insulin Sensitivity in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine and Risperidone

Eli Lilly and Company1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2003年10月最近更新:
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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
130
试验地点
1
主要终点
Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •18-65 years old
  • •Diagnosed with Schizophrenia or Schizoaffective disorder
  • •Ability to visit the doctor's office for scheduled visits

排除标准

  • •Women who are pregnant or breastfeeding
  • •Have a body mass index (BMI) greater than 40
  • •Have diabetes, heart disease or any other unstable illness
  • •Have known positive human immunodeficiency virus (HIV)
  • •Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable antipsychotics

研究组 & 干预措施

Olanzapine

Experimental

干预措施: olanzapine (Drug)

Risperidone

Active Comparator

干预措施: risperidone (Drug)

结局指标

主要结局

Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate

时间窗: baseline and 12 weeks

Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:\[(mg glucose)\*min\*mL\] / \[(kg fat free body mass)\*(micro IU insulin)\]

次要结局

  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.(12 weeks)
  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)(12 weeks)
  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Ratio of Visceral Fat Area to the Subcutaneous Fat Area.(12 weeks)
  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.(12 weeks)
  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.(12 weeks)
  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.(12 weeks)
  • Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.(12 weeks)
  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.(12 weeks)
  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.(12 weeks)
  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.(12 weeks)
  • Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.(12 weeks)
  • Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.(12 weeks)
  • Change From Baseline to 12 Week Endpoint in Body Mass Index(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Weight(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Waist Circumference(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Visceral Fat Area(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides(baseline and 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses(baseline and 12 weeks.)

研究者

申办方类型
Industry

研究点 (1)

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