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临床试验/NCT00773916
NCT00773916已完成4 期

The Role of Adverse Environment Factors, Family Functioning and Parental Psychopathology in the Response to Treatment With Methylphenidate in Children and Adolescents With Attention Deficit/Hyperactivity Disorder

Federal University of Rio Grande do Sul2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2006年3月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
130
试验地点
2
主要终点
SNAP -IV scores

研究概览

简要总结

The purpose of this study is to investigate the association of adverse environmental factors, parental psychopathology, family functioning and genetic factors and the response to methylphenidate treatment in children and adolescents with Attention Deficit/Hyperactivity Disorder.

详细描述

Attention Deficit/Hyperactivity Disorder (ADHD) is a chronic disorder, with a worldwide estimated prevalence of 5,29%. It is associated with a high risk of functional impairment in many aspects of the patient´s life, such as academic achievements, peers relationships and physical injuries. There are few studies assessing predictive factors of clinical response to treatment. Different patterns of family functioning, such as high family conflict and low family cohesion might be associated with a poor treatment response, possibly mediating the effects of higher severity af the disorder and/or higher prevalence of comorbidity. Parental psychopathology has been associated with a poorer prognosis and is related with family functioning. Adverse social factors have long been studied and are associated with an increased risk for general mental disease, including ADHD, as well as a poorer prognosis. Different genetic factors have been studied and associated with different aspects of the disorder and different clinical responses to treatments. There are no studies evaluating how those factors interact with each other in a Brazilian population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 5 - 18
  • Primary Indication of Methylphenidate

排除标准

  • Clinical conditions that preclude use of methylphenidate

结局指标

主要结局

SNAP -IV scores

时间窗: 1, 2, 3 and 6 months of treatment

CGI scores

时间窗: 1, 2, 3 and 6 months of treatment

次要结局

  • Scores in CGAS(1, 2, 3 and 6 months of treatment)

研究者

发起方
Federal University of Rio Grande do Sul
申办方类型
Other

研究点 (2)

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