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Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions

This study is currently recruiting participants.
Verified by Barzilai Medical Center, August 2006

Sponsored by: Barzilai Medical Center
Information provided by: Barzilai Medical Center
ClinicalTrials.gov Identifier: NCT00372359
  Purpose

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


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

MedlinePlus related topics:   Attention Deficit Hyperactivity Disorder   

ChemIDplus related topics:   Methylphenidate hydrochloride    Methylphenidate   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Cross-Sectional, Case Control, Retrospective Study

Further study details as provided by Barzilai Medical Center:

Estimated Enrollment:   50
Study Start Date:   August 2006
Estimated Study Completion Date:   August 2006

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
Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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
Barzilai Medical Center

Investigators
Principal Investigator:     Shraga Aviner, MD, PhD     The Barzilai Medical Center, Ashkelon, Israel    
  More Information


Publications:

Study ID Numbers:   BAR1400
First Received:   September 3, 2006
Last Updated:   September 3, 2006
ClinicalTrials.gov Identifier:   NCT00372359
Health Authority:   Israel: Ministry of Health

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

Study placed in the following topic categories:
Signs and Symptoms
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Methylphenidate
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Stimulants
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2008




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