Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372359
Status:
UNKNOWN
Last Update Posted:
2012-09-20
First Post:
2006-09-03
Brief Title:
Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions
Sponsor:
Ornit Cohen
Organization:
Barzilai Medical Center
Study Overview
Official Title:
Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions
Status:
UNKNOWN
Status Verified Date:
2012-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None