Adverse Effect of Prolonged Methylphenidate Treatment on... | NCT00372359

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Not provided

Completion Date

Dec 2012Estimated

First Submitted Date

Sep 3, 2006

First Submission Date that Met QC Criteria

Sep 3, 2006

First Posted Date

Sep 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2012

Last Update Posted Date

Sep 20, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ornit Cohen, r&d unit, Barzilai Medical CenterSponsor-Investigator

Lead Sponsor

Ornit CohenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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

Keywords

Attention Deficit Disorder
Hyperactivity
Methylphenidate

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children aged 8-18 that are at least 5 years on methylphenidates

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shraga Aviner, MD, PhD	Contact	972 3 674 5165		aviners@barzi.health.govb.il
Olga Kissilgof, MD	Contact	972 8 674 5261

Overall Officials

Name	Affiliation	Role
Shraga Aviner, MD, PhD	The Barzilai Medical Center, Ashkelon, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Day Care Center, The Barzilai Medical Center	Recruiting	Ashkelon		78306	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16723627	Background	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.
16772535	Background	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.

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity
D013035	Spasm

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms