- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00372359
Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Shraga Aviner, MD, PhD
- Telefonnummer: 972 3 674 5165
- E-post: aviners@barzi.health.govb.il
Studera Kontakt Backup
- Namn: Olga Kissilgof, MD
- Telefonnummer: 972 8 674 5261
Studieorter
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Ashkelon, Israel, 78306
- Rekrytering
- Pediatric Day Care Center, The Barzilai Medical Center
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Kontakt:
- Olga Kissilgof, MD
- Telefonnummer: 972 8 674 5261
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Kontakt:
- Shraga Aviner, MD, PhD
- Telefonnummer: 972 8 674 5165
- E-post: aviners@barzi.health.gov.il
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Huvudutredare:
- Shraga Aviner, MD, PhD
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Underutredare:
- Olga Kissilgof, MD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Shraga Aviner, MD, PhD, The Barzilai Medical Center, Ashkelon, Israel
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- Nissen 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.
- Debate over warnings for ADHD stimulants. Child Health Alert. 2006 Apr;24:1. No abstract available.
Studieavstämningsdatum
Studera stora datum
Studiestart
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BAR1400CTIL
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