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Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions

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ClinicalTrials.gov Identifier: NCT00372359
Recruitment Status : Unknown
Verified September 2012 by Ornit Cohen, Barzilai Medical Center.
Recruitment status was:  Recruiting
First Posted : September 6, 2006
Last Update Posted : September 20, 2012
Sponsor:
Information provided by (Responsible Party):
Ornit Cohen, Barzilai Medical Center

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.

Condition or disease
Attention Deficit Disorder With Hyperactivity Attention Deficit Disorder Attention Deficit Hyperactivity Disorder Attention Deficit Disorders With Hyperactivity Attention Deficit Hyperactivity Disorders

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.


Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions
Study Start Date : August 2006
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children aged 8-18 that are at least 5 years on methylphenidates
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372359


Contacts
Contact: Shraga Aviner, MD, PhD 972 3 674 5165 aviners@barzi.health.govb.il
Contact: Olga Kissilgof, MD 972 8 674 5261

Locations
Israel
Pediatric Day Care Center, The Barzilai Medical Center Recruiting
Ashkelon, Israel, 78306
Contact: Shraga Aviner, MD, PhD    972 8 674 5165    aviners@barzi.health.gov.il   
Contact: Olga Kissilgof, MD    972 8 674 5261      
Principal Investigator: Shraga Aviner, MD, PhD         
Sub-Investigator: Olga Kissilgof, MD         
Sponsors and Collaborators
Ornit Cohen
Investigators
Principal Investigator: Shraga Aviner, MD, PhD The Barzilai Medical Center, Ashkelon, Israel

Publications:
Responsible Party: Ornit Cohen, r&d unit, Barzilai Medical Center
ClinicalTrials.gov Identifier: NCT00372359     History of Changes
Other Study ID Numbers: BAR1400CTIL
First Posted: September 6, 2006    Key Record Dates
Last Update Posted: September 20, 2012
Last Verified: September 2012

Keywords provided by Ornit Cohen, Barzilai Medical Center:
Attention Deficit Disorder
Hyperactivity
Methylphenidate

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents