EUCTR2011-000567-26-DE进行中（未招募）不适用
A randomised double-blind, placebo-controlled study of risperidone in the treatment of DSM-IV-TR conduct disorder in children and adolescents. - acute CONCA study (CONduct Disorder in Children and Adolescents)
Radboud University Medical Centre Nijmegen0 个研究点目标入组 264 人开始时间: 2012年8月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patient will only be eligible for inclusion in the acute CONCA study if they fulfil all of the following inclusion criteria:-
- •1. male or female aged 5.0-17.9 years at Visit 1
- •2. intelligence quotient of >85 (based on 4 subtests of the Weschler intelligence scales- vocabulary, matrix reasoning, block design, and similarities; compare with Crawford et al., 2010)
- •3. a DSM-IV-TR diagnosis of conduct disorder, as confirmed by the Kiddies-SADS Conduct Disorder Module: 312.8x (Kaufman et al., 1996), at Visit 2 and Visit 3
- •4. a minimum score of 27 on the Nisonger CBRF ODD/CD disruptive Behaviour Composite (D-Total) at either Visit 2 or Visit 3
- •5. a minimum score of 4 (moderately ill; or >5 markedly ill) on the Clinical Global Impression- Severity scale at Visit 2 and Visit 3
- •6. in female patients of child-bearing potential, the serum pregnancy test at the time of enrollment must be negative; and these patients must agree to use a reliable method of contraception (i.e. oral contraceptives; intrauterine devices; double-barrier methods - diaphragm or condom with spermicide; Norplant or depot Provera)
- •7. a body weight of at least 20kg at study entry
- •8. patients must be able to swallow the study tablets
- •9. patients must have sufficient venous access to allow blood sampling and be compliant with blood sampling as stated in the protocol
- •10. the subject's parents/legal guardians must provide written informed consent; patients must provide informed consent and sign the consent/assent documents if capable, in accordance with the legal requirements of the respective country
- •11. a reliable person (primary caregiver, parent) must be available throughout the course of the study to ensure compliance with the study procedures
- •12. patients meeting the criteria for comorbid ADHD (according to the clinical judgement of the investigator) will not be excluded from study participation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 88
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A patient will be excluded from the study if he/she meets any of the following exclusion criteria:-
- •1. is a member of the immediate family of any investigator site personnel directly affiliated with the study. Immediate family is defined as spouse, parent, child, or sibling, whether biological or adopted
- •2. has been treated within the 14 day period prior to Visit 1 with a drug that has not received regulatory approval for any indication at the time of study entry
- •3. has participated in any investigational drug trial within the six month period prior to baseline (Visit 3)
- •4. has previously completed or withdrawn from this study, or has previously been identified as a non-responder to or intolerant of risperidone
- •5. has a current (i.e. within 6 months of the start of the study) or lifetime DSM-IV-TR diagnosis of a schizophrenia-related disorder; schizophrenia; bipolar disorder; major depression; current substance dependence disorder (given the nature of the study population, substance missue or -abuse is not exclusionary); or pervasive developmental disorder (autistic disorder or Asperger disorder)
- •6. in the clinical judgement of the investigator, the patient meets the criteria for a primary psychiatric disorder, e.g. an anxiety disorder, depressive disorder, Tic disorder, or Tourette Syndrome (comorbid ADHD is permitted, see inclusion criteria)
- •7. the patient starts any psychotropic medication during the course of the study, including health-food supplements, that may, in the opinion of the investigator, affect central nervous system activity, or is taking any other excluded medication at or beyond Visit 2 (specified in Section 5.7 of the study protocol). A long-term medication - e.g. to treat a comorbid disorder such as ADHD - is permitted as long as the compound and the dose remain unchanged throughout the course of the study
- •8. has any acute or unstable medical condition, physiological condition, clinically significant laboratory or ECG results that - in the opinion of the investigator - would compromise study participation
- •9. has a known or suspected seizure disorder
- •10. has a history of neuroleptic malignant syndrome or tardive dyskinesia
- •11. has a history of hypersensitivity to neuroleptics
- •12. is pregnant or nursing.
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A randomized double-blind, placebo-controlled study of risperidone in the treatment of DSM-IV-TR conduct disorder in children and adolescents. - CONCAConduct Disorder DSM-IV-TR312.8x¸ APA, 2000MedDRA version: 14.1Level: PTClassification code 10064478Term: Conduct disorderSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2011-000567-26-NLRadboud University Medical Centre Nijmegen264