ISRCTN95429815已完成未知
A randomized double blind, placebo controlled study of risperidone in the treatment of DSM-IV-TR conduct disorder in children and adolescents
Radboud University Nijmegen Medical Centre (Netherlands)0 个研究点目标入组 264 人开始时间: 2012年4月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 264
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. This study will include male and female inpatients or outpatients
- •2. Aged between 5 years and 17 years and 9 months
- •3. Patients must meet DSM-IV-TR diagnostic criteria for DSM-IV-TR Conduct Disorder(s)
- •4. Patients must have an IQ of > 85
- •5. If a female of child-bearing potential, patients must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a reliable method of birth control
- •6. Patients must have a body weight of at least 20 kg at study entry
- •7. Patients must be able to swallow study drug
- •8. Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws
排除标准
- •1. Has been treated with a drug within 14 days before Visit 1 that has not received regulatory approval for any indication at the time of study entry
- •2. Has participated in any investigational drug trial within six months prior to baseline
- •3. Has previously completed or withdrawn from this study or any other study investigating risperidone or has previously been identified as being a nonresponder or intolerant of risperidone
- •4. Has a current (within 6 months of the start of the study) or lifetime DSM-IV-TR diagnosis of schizophrenia-related disorders, schizophrenia, bipolar disorder, major depressive disorder, or current substance dependence disorder (given the nature of the study population substance misuse or abuse is not exlusionary), pervasive developmental disorder (autistic disorder or Asperger disorder).
- •5. In the clinical judgment of the investigator, currently meets criteria for a primary psychiatric disorder, e.g., Anxiety Disorder, Depressive Disorder, Tic Disorder or Tourette?s Syndrome
- •6. Starts any psychotropic medication, including health-food supplements that the investigator feels could have central nervous system activity
- •7. Has any acute or unstable medical condition, physiological condition, clinically significant laboratory, or ECG results that, in the opinion of the investigator, would compromise participation in the study.
- •8. Has a known or suspected seizure disorder
- •9. Has a history of neuroleptic malignant syndrome (NMS) or of tardive dyskinesia
- •10. Has a history of hypersensitivity to neuroleptics
- •11. Is pregnant or nursing
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