Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00372359
• Other study ID #: BAR1400CTIL
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2006
• Last updated: September 19, 2012
• Start date: August 2006
• Est. completion date: December 2012

Study information

• Verified date: September 2012
• Source: Barzilai Medical Center
• Contact: Shraga Aviner, MD, PhD
• Phone: 972 3 674 5165
• Email: aviners[@]barzi.health.govb.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder With Hyperactivity
• Attention Deficit Disorders With Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Attention Deficit Hyperactivity Disorders
• Disease
• Hyperkinesis

Locations

Country	Name	City	State
Israel	Pediatric Day Care Center, The Barzilai Medical Center	Ashkelon

Sponsors (1)

Lead Sponsor	Collaborator
Ornit Cohen

Country where clinical trial is conducted

Israel, 

References & Publications (4)

Cohen AL, Jhung MA, Budnitz DS. Stimulant medications and attention deficit-hyperactivity disorder. N Engl J Med. 2006 May 25;354(21):2294-5. — View Citation

Debate over warnings for ADHD stimulants. Child Health Alert. 2006 Apr;24:1. — View Citation

Nissen SE. ADHD drugs and cardiovascular risk. N Engl J Med. 2006 Apr 6;354(14):1445-8. Epub 2006 Mar 20. — View Citation

Wooltorton E. Medications for attention deficit hyperactivity disorder: cardiovascular concerns. CMAJ. 2006 Jul 4;175(1):29. Epub 2006 Jun 13. — View Citation