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临床试验/NCT00255879
NCT00255879已完成1 期

Neuroleptic Induced Movement Disorders in Older Patients

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 1999年1月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
250
试验地点
2
主要终点
Extrapyramidal symptoms; measured at Months 1 and 3 and every 3 months for the remainder of the study

研究概览

简要总结

This study will assess the risk of experiencing tardive dyskinesia and other movement disturbances associated with three atypical antipsychotic drugs among middle-aged and elderly psychiatric patients.

详细描述

Use of antipsychotic drugs can result in tardive dyskinesia and extrapyramidal symptoms. Tardive dyskinesia (TD) is a syndrome that causes repetitive, involuntary, purposeless movements in the tongue, lips, or jaw. It can also cause facial grimacing, random movements of arms, legs, fingers, and toes, as well as swaying movements of the trunk or hips. Extrapyramidal symptoms (EPS) include a variety of symptoms, such as involuntary movements, tremors, rigidity, body restlessness, and changes in breathing and heart rate. TD and EPS are side effects of older antipsychotic drugs. Newer antipsychotic drugs, such as quetiapine, olanzapine, and risperidone, do not present as large a risk of developing these side effects. This study will assess the incidence of and risk factors for tardive dyskinesia and extrapyramidal symptoms associated with quetiapine, olanzapine, and risperidone among middle-aged and elderly individuals with psychotic disorders. Additionally, the study will examine the effect of these drugs on symptoms of pre-existing, drug-induced TD. It will also explore the impact of movement disorder symptoms on everyday functioning and quality of life.

Some participants in this open-label study will be randomly assigned to receive quetiapine, olanzapine, or risperidone. Participants who are not randomly assigned to a medication will still receive one of the three medications, based on the decision of their physician. Initial evaluations will be conducted to collect demographic information, as well as medical, psychiatric, and pharmacologic histories. Dosing will be determined by each participant's psychiatrist. All participants will be followed for approximately 5 years. They will report to the study site for outcome assessments at baseline, Months 1 and 3, and every 3 months for the remainder of the study.

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 any psychiatric disorder for which an antipsychotic medication is needed

排除标准

  • 未提供

结局指标

主要结局

Extrapyramidal symptoms; measured at Months 1 and 3 and every 3 months for the remainder of the study

Tardive dyskinesia; measured at Months 1 and 3 and every 3 months for the remainder of the study

次要结局

  • Everyday functioning; measured at Months 1 and 3 and every 3 months for the remainder of the study
  • Quality of life; measured at Months 1 and 3 and every 3 months for the remainder of the study

研究者

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

Dilip V. Jeste

Professor

University of California, San Diego

研究点 (2)

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