跳至主要内容
临床试验/NCT00245206
NCT00245206已完成4 期

Metabolic Effects of Newer Antipsychotics in Older Patients

Veterans Medical Research Foundation1 个研究点 分布在 1 个国家目标入组 406 人开始时间: 2005年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
406
试验地点
1
主要终点
Change in Body Mass Index

研究概览

简要总结

This study will compare four atypical antipsychotic medications in terms of the risk of specific side effects each of them presents in middle-aged and elderly individuals.

详细描述

Atypical antipsychotic medications introduced within the last decade have been used increasingly for the treatment of several types of psychotic disorders and severe behavioral disturbances in older individuals. This trend is primarily due to a decrease in side effects caused by the new medications, as compared to conventional neuroleptic medications. There is a lower risk for developing tardive dyskinesia and extrapyramidal symptoms, both of which are movement abnormalities, with new antipsychotic medications. However, there has been a growing concern that the newer medications can cause a different set of potentially serious adverse side effects. Specifically, they may cause long-term metabolic, cardiovascular, and cerebrovascular effects, which may result in weight gain, diabetes, or stroke. This study will compare four atypical antipsychotic medications in terms of the risk of metabolic, cardiovascular, and cerebrovascular side effects that each presents in middle-aged and elderly individuals.

Participants in this open-label study will be randomly assigned to receive one of three atypical antipsychotic medications: aripiprazole; olanzapine; or risperidone. Although assignment is random, a technique that may reflect the participant's own interests or the researcher's knowledge of relevant participant characteristics will be used to assign the participant to a medication. Dosing will be determined by each participant's psychiatrist. Participants will be followed for up to 5 years to assess the side effects of the study medications, with study visits at baseline, Week 6, and every 3 months thereafter.

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication

排除标准

  • 未提供

研究组 & 干预措施

1: Risperdal

Experimental

Participants randomized to this arm will be prescribed risperdal. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.

干预措施: Risperidone (Drug)

3: Aripiprazole

Experimental

Participants randomized to this arm will be prescribed aripiprazole. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.

干预措施: Aripiprazole (Drug)

4: Olanzapine

Experimental

Participants randomized to this arm will be prescribed olanzapine. They will continue to be followed by their psychiatrist. In addition, they will take part in ongoing biological, cognitive, and psycho-social assessments with study staff.

干预措施: Olanzapine (Drug)

结局指标

主要结局

Change in Body Mass Index

时间窗: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Change in body mass index (BMI) between each study visit. weight and height will be combined to report BMI in kg/m\^2. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)

Change in Fasting Plasma Glucose (FPG)

时间窗: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Blood sample collected to measure Fasting Plasma Glucose (FPG) to determine if there are changes between study visits. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)

Change in LDL cholesterol, HDL cholesterol, and triglycerides

时间窗: Measured at baseline, Week 6, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Lipid Panel collected to measure LDL cholesterol, HDL cholesterol, and triglycerides and determine if there are changes between study visits. (This hypothesis is non-directional because of uncertainties with respect to significant between-drug differences on these measures.)

次要结局

未报告次要终点

研究者

发起方
Veterans Medical Research Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilip V. Jeste

Psychiatry

Veterans Medical Research Foundation

研究点 (1)

Loading locations...

相似试验