Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Barzilai Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ornit Cohen, Barzilai Medical Center
ClinicalTrials.gov Identifier:
NCT00372359
First received: September 3, 2006
Last updated: September 19, 2012
Last verified: September 2012
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions

Resource links provided by NLM:


Further study details as provided by Barzilai Medical Center:

Estimated Enrollment: 50
Study Start Date: August 2006
Estimated Study Completion Date: December 2012
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
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Ornit Cohen, r&d unit, Barzilai Medical Center
ClinicalTrials.gov Identifier: NCT00372359     History of Changes
Other Study ID Numbers: BAR1400CTIL
Study First Received: September 3, 2006
Last Updated: September 19, 2012
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Disease
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014