Attention Deficit Disorder With HyperactivityNCT00372359
Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions
An observational study of Attention Deficit Disorder With Hyperactivity and Attention Deficit Disorder, run by Ornit Cohen at 1 site in Israel.
Trial summary
The purpose of this study is to find out whether prolonged treatment with methylphenidate has any adverse effect on cardiac functions and measurements. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2006to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 8-18 that are at least 5 years on methylphenidates
Who may be able to join
- Children with ADHD aged 8-18 years who are taking methylphenydate (Ritalin©, Ritalin SR©, Ritalin LA©) for more than 5 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Olga Kissilgof, MD contact
Israel1 site, 1 recruiting
- Recruiting
Pediatric Day Care Center, The Barzilai Medical Center
Ashkelon, 78306
Shraga Aviner, MD, PhD, 972 8 674 5165, aviners@barzi.health.gov.il
Olga Kissilgof, MD, 972 8 674 5261
About this study
The purpose of this study is to find out whether prolonged treatment with methylphenidate has any adverse effect on cardiac functions and measurements.
Read the 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
- 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
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startAug 2006
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ornit Cohen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ornit Cohen, Barzilai Medical Center
- Investigators
- Shraga Aviner, MD, PhD, Principal investigator, The Barzilai Medical Center, Ashkelon, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372359
- Sponsor's protocol ID
- BAR1400CTIL
- Status last verified
- Sep 2012
- First submitted
- 3 Sep 2006
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16723627Wooltorton 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.
PubMed 16772535Nissen SE. ADHD drugs and cardiovascular risk. N Engl J Med. 2006 Apr 6;354(14):1445-8. doi: 10.1056/NEJMp068049. Epub 2006 Mar 20. No abstract available.
PubMed 16549404Debate over warnings for ADHD stimulants. Child Health Alert. 2006 Apr;24:1. No abstract available.
PubMed 16673500
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions
- ClinicalTrials.gov ID
- NCT00372359
- Acronym / sponsor ID
- BAR1400CTIL
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ornit CohenUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Dec 2012 (estimated)
- First posted
- 6 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 8-18 that are at least 5 years on methylphenidates
Key inclusion criteria (1 listed)
- Children with ADHD aged 8-18 years who are taking methylphenydate (Ritalin©, Ritalin SR©, Ritalin LA©) for more than 5 years.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2012.
- Background: PubMed 16723627Cohen 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.
- Background: PubMed 16772535Wooltorton 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.
- Background: PubMed 16549404Nissen SE. ADHD drugs and cardiovascular risk. N Engl J Med. 2006 Apr 6;354(14):1445-8. doi: 10.1056/NEJMp068049. Epub 2006 Mar 20. No abstract available.
- Background: PubMed 16673500Debate over warnings for ADHD stimulants. Child Health Alert. 2006 Apr;24:1. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Kissilgof, MD contact
Shraga Aviner, MD, PhD principal investigator
The Barzilai Medical Center, Ashkelon, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder With Hyperactivity and Attention Deficit Disorder, run by Ornit Cohen at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shraga Aviner, MD, PhD (972 3 674 5165, aviners@barzi.health.govb.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00372359, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2012.