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Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions

NCT ID: NCT00372359

Last Updated: 2012-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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Attention Deficit Disorder Hyperactivity Methylphenidate

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ornit Cohen

OTHER

Sponsor Role lead

Responsible Party

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Ornit Cohen

r&d unit

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shraga Aviner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Barzilai Medical Center, Ashkelon, Israel

Locations

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Pediatric Day Care Center, The Barzilai Medical Center

Ashkelon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Shraga Aviner, MD, PhD

Role: CONTACT

Phone: 972 3 674 5165

Email: [email protected]

Olga Kissilgof, MD

Role: CONTACT

Phone: 972 8 674 5261

Facility Contacts

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Shraga Aviner, MD, PhD

Role: primary

Olga Kissilgof, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 16723627 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16772535 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16549404 (View on PubMed)

Debate over warnings for ADHD stimulants. Child Health Alert. 2006 Apr;24:1. No abstract available.

Reference Type BACKGROUND
PMID: 16673500 (View on PubMed)

Other Identifiers

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BAR1400CTIL

Identifier Type: -

Identifier Source: org_study_id