An observational study in Attention Deficit Disorder With Hyperactivity, Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder, sponsored by Ornit Cohen. Status unknown at 1 site in Israel. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2012-09-20.
Sponsored by Ornit Cohen · Observational
The purpose of this study is to find out whether prolonged treatment with methylphenidate has any adverse effect on cardiac functions and measurements.
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.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's planned enrollment of 50 is below the median of 134 across 122 observational studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →Ornit Cohen is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children aged 8-18 that are at least 5 years on methylphenidates
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.
This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Ornit Cohen