Clinical trial NCT00372359: Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions
Official title: Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention Deficit Disorder With Hyperactivity
Attention Deficit Disorder
Attention Deficit Hyperactivity Disorder
Attention Deficit Disorders With Hyperactivity
Attention Deficit Hyperactivity Disorders
Keywords: Attention Deficit Disorder
Hyperactivity
Methylphenidate
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
First posted: 2006-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 8-18 that are at least 5 years on methylphenidates

Brief summary: The purpose of this study is to find out whether prolonged treatment with methylphenidate has any adverse effect on cardiac functions and measurements.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Pediatric Day Care Center, The Barzilai Medical Center
Study officials:
affiliation: The Barzilai Medical Center, Ashkelon, Israel
name: Shraga Aviner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Debate over warnings for ADHD stimulants. Child Health Alert. 2006 Apr;24:1. No abstract available.