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临床试验/NCT00288366
NCT00288366已完成不适用

Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome

Northwestern University1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2006年1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
49
试验地点
1
主要终点
HDL Ratio

研究概览

简要总结

The objective of this study is to determine the effect of various mood stabilizers (MS) on the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in patients treated with antipsychotic drugs (APDs). Patients will be switched from their current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless clinically contraindicated) for comparison with metabolic levels during treatment with the former medication.

The metabolic syndrome is an empirical concept based on extensive evidence that a constellation of 5 metabolic abnormalities, e.g. increased cholesterol, hypertension, low HDL, taken together, predict marked increases in the risk of CVD, stroke and some types of cancer.

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
None

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

1

Active Comparator

aripiprazole (Abilify)

干预措施: ziprasidone vs. aripiprazole (Drug)

1

Active Comparator

aripiprazole (Abilify)

干预措施: aripiprazole vs. ziprasidone (Drug)

2

Active Comparator

ziprasidone (Geodon)

干预措施: aripiprazole vs. ziprasidone (Drug)

结局指标

主要结局

HDL Ratio

时间窗: 24 weeks from Baseline

change in HDL ratio after medication switch

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Herbert Meltzer

Professor

Vanderbilt University

研究点 (1)

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