Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions
研究概览
详细说明
Attention deficit hyperactivity disorder (ADHD) is the most common neurobehavioral condition of childhood, with symptoms consisting of inattentiveness, impulsivity and hyperactivity. The diagnosis relies on subjective criteria since there is no objective test for ADHD. Stimulants are the recommended treatment, during the last 2 decades both the rate of its use has increased, and the age for starting treatment has decreased. Adverse side effects have been few, none of which were serious.
Recently, regulators of the Food and Drug Administration (FDA) have been told on forty deaths among patients who took stimulants through 2003. Accordingly, a subcommittee of the FDA recommended that prescription drugs to treat ADHD should be accompanied by strong 'black-box' warnings that they may increase the risk of heart problems in some patients.
To date, there does not appear to have been any study that has evaluated cardiac functions in these patients. In this study we will evaluate the possible long term effect of methylphenidate on cardiac functions, as to provide more knowledgeable basis for decisions on the treatment of ADHD patients with methylphenidate.
Children age 8-18 years who were treated on methylphenidate for more then five years will be allocated in outpatient clinics. Complete EKG and echocardiographic examinations will be performed and cardiac functions, left ventricular mass and left ventricular muscle width will be compared to the normal range of values. The results will give us, for the first time, a basis to support or reject the causative relationship between these drugs and severe cardiac problems.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Shraga Aviner, MD, PhD
- 电话号码:972 3 674 5165
- 邮箱:aviners@barzi.health.govb.il
研究联系人备份
- 姓名:Olga Kissilgof, MD
- 电话号码:972 8 674 5261
学习地点
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Ashkelon、以色列、78306
- 招聘中
- Pediatric Day Care Center, The Barzilai Medical Center
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接触:
- Olga Kissilgof, MD
- 电话号码:972 8 674 5261
-
接触:
- Shraga Aviner, MD, PhD
- 电话号码:972 8 674 5165
- 邮箱:aviners@barzi.health.gov.il
-
首席研究员:
- Shraga Aviner, MD, PhD
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副研究员:
- Olga Kissilgof, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
Children with ADHD aged 8-18 years who are taking methylphenydate (Ritalin©, Ritalin SR©, Ritalin LA©) for more than 5 years.
Exclusion Criteria:
Children with any known heart disease or anomaly. Children whose ADHD is part of a syndrome or are mentally retarded. Children that are on any other chronic medications.
学习计划
研究是如何设计的?
设计细节
合作者和调查者
赞助
调查人员
- 首席研究员:Shraga Aviner, MD, PhD、The Barzilai Medical Center, Ashkelon, Israel
出版物和有用的链接
一般刊物
- Cohen AL, Jhung MA, Budnitz DS. Stimulant medications and attention deficit-hyperactivity disorder. N Engl J Med. 2006 May 25;354(21):2294-5. doi: 10.1056/NEJMc060860. No abstract available.
- Wooltorton E. Medications for attention deficit hyperactivity disorder: cardiovascular concerns. CMAJ. 2006 Jul 4;175(1):29. doi: 10.1503/cmaj.060718. Epub 2006 Jun 13. No abstract available.
- Nissen SE. ADHD drugs and cardiovascular risk. N Engl J Med. 2006 Apr 6;354(14):1445-8. doi: 10.1056/NEJMp068049. Epub 2006 Mar 20. No abstract available.
- Debate over warnings for ADHD stimulants. Child Health Alert. 2006 Apr;24:1. No abstract available.
研究记录日期
研究主要日期
学习开始
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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