NL-OMON38186尚未招募不适用
A randomized double-blind, placebo-controlled study of risperidone in the treatment of DSM-IV-TR conduct disorder in children and adolescents. - CONCA
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 38 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
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
- 年龄范围
- 2 至 17（—）
入选标准
- •Patients are eligible to be included in the study only if they meet all of the inclusion criteria below. ;- Male or female patients aged 5.0 - <17 years and 9 months at Visit 1.;- Patients must have an IQ of > 85
- •- Patients must meet DSM-IV-TR diagnostic criteria for DSM-IV-TR Conduct Disorder(s) as confirmed by the Kiddie-SADS, Conduct Disorder Module: 312.8x. (Kaufman et al., 1996)
- •- Patients must score >= 27 on the Nisonger CBR Form, ODD/CD Disruptive Behavior Composite (D-Total)
- •- Patients must score >=4 (*moderately ill* (or >5, *markedly ill*) on the CGI-S rating scale
- •- 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.
- •- Patients must have a body weight of at least 25 kg at study entry.
- •- Patients must be able to swallow study drug.
- •- Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws as per protocol
- •- Patients meeting criteria for comorbid ADHD (as to the clinical judgment of the investigator) will not be excluded from study participation.
排除标准
- •A patient will be excluded from the study if he or she meets any exclusion criteria described below, according to the assessment of the investigator.;- 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.
- •- Has participated in any investigational drug trial within six months prior to baseline (visit 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- •- Has previously completed or withdrawn from this study or any other study investigating risperidone or has previously been identified as being a nonresponder or intolerant of risperidone.
- •- 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, pervasive developmental disorder (autistic disorder or Asperger disorder).
- •- In the clinical judgment of the investigator, meets criteria for a primary psychiatric disorder, e.g., Anxiety Disorder, Depressive Disorder, Tic Disorder or Tourette*s Syndrome
- •- Starts any psychotropic medication, including health-food supplements that the investigator feels could have central nervous system activity (for example, St. John*s Wort, melatonin), during the course of the study, or is taking any other excluded concomitant medication(s) at/beyond Visit 2. (An ongoing long-term medication, e.g., to treat a comorbid disorder such as ADHD, is permitted as long as compound and dose are not changed throughout the course of the study.)
- •- 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.
- •- Has a known or suspected seizure disorder.
- •- Has a history of neuroleptic malignant syndrome (NMS) or of tardive dyskinesia.
- •- Has a history of hypersensitivity to neuroleptics, of tardive dyskinesia, or neuroleptic malignant syndrome.
- •- Is pregnant or nursing.
研究者
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