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临床试验/NCT00097032
NCT00097032已完成3 期

Differences in Cognitive Function Due to Acute Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Out-Patients.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.0 个研究点目标入组 30 人开始时间: 2004年10月1日最近更新:
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试验速览

阶段
3 期
状态
已完成
入组人数
30
主要终点
To compare the treatment effects of risperidone and quetiapine on cognitive function due to sedation

研究概览

简要总结

The purpose of this study is to determine whether the sedating (causing sleepiness) effects of risperidone or quetiapine alter cognitive (person's ability to think, perceive, recognize, remember, judge, and reason) functioning in subjects with stable Bipolar I Disorder.

详细描述

To compare the treatment effects of risperidone and quetiapine on cognitive function, using measures commonly believed to be affected by sedation and at doses typically used in clinical settings in stable bipolar I outpatients.One-half of patients are randomized to treatment sequence risperidone-quetiapine (R-Q), and the other one-half to quetiapine-risperidone (Q-R). Patients randomized to R-Q receive 2 mg of risperidone with dinner the night before testing and placebo with breakfast on the day of testing. After a 6 - 14 day washout period they receive 100 mg quetiapine with dinner the night before their second day of testing and 100 mg with breakfast the day of testing.

Those randomized to Q-R receive the same treatments, but in reverse order. Patients randomized to R-Q receive 2 mg of risperidone with dinner the night before testing and placebo with breakfast on the day of testing. After a 6-14 day washout period they receive 100 mg quetiapine with dinner the night before their second day of testing and 100 mg with breakfast the day of testing. Those randomized to Q-R receive the same treatments, but in reverse order.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Double

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Subjects with bipolar I disorder in partial or full remission and deemed clinically stable

排除标准

  • •Current use of benzodiazepines, prescription or herbal sleep agents
  • •Use of antihistamines
  • •Use of antipsychotic medications in the past 6 months
  • •Pregnant/breastfeeding females
  • •Females not using contraception
  • •Illicit drug users

结局指标

主要结局

To compare the treatment effects of risperidone and quetiapine on cognitive function due to sedation

次要结局

  • To assess the association between subjective experience of sedation and cognitive function

研究者

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