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Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions

Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00372359
Enrollment
50
Registered
2006-09-06
Start date
2006-08-31
Completion date
2012-12-31
Last updated
2012-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder, Attention Deficit Disorders With Hyperactivity, Attention Deficit Disorder With Hyperactivity, Attention Deficit Hyperactivity Disorder, Attention Deficit Hyperactivity Disorders

Keywords

Attention Deficit Disorder, Hyperactivity, Methylphenidate

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.

Interventions

None listed

Sponsors

Ornit Cohen
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

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.

Countries

Israel

Contacts

Primary ContactShraga Aviner, MD, PhD
aviners@barzi.health.govb.il972 3 674 5165
Backup ContactOlga Kissilgof, MD
972 8 674 5261

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026