- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00372359
Adverse Effect of Prolonged Methylphenidate Treatment on Cardiac Functions
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Shraga Aviner, MD, PhD
- Telefonnummer: 972 3 674 5165
- E-mail: aviners@barzi.health.govb.il
Undersøgelse Kontakt Backup
- Navn: Olga Kissilgof, MD
- Telefonnummer: 972 8 674 5261
Studiesteder
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Ashkelon, Israel, 78306
- Rekruttering
- 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-mail: aviners@barzi.health.gov.il
-
Ledende efterforsker:
- Shraga Aviner, MD, PhD
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Underforsker:
- Olga Kissilgof, MD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Shraga Aviner, MD, PhD, The Barzilai Medical Center, Ashkelon, Israel
Publikationer og nyttige links
Generelle 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BAR1400CTIL
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Kliniske forsøg med Attention Deficit Hyperactivity Disorder
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Children's National Research InstituteRekrutteringADHD | Attention Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder | Attention Deficit Disorder | TILFØJE | ADHD Overvejende uopmærksom type | ADHD - kombineret type | ADHD, overvejende hyperaktiv - impulsiv | Attention-Deficit Disorder i ungdomsårene | Attention-Deficit Hyperactivity...Forenede Stater
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Purdue Pharma LPAfsluttetAttention Deficit/Hyperactivity DisorderForenede Stater
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The Hospital for Sick ChildrenEhave; Ontario Brain InstituteAfsluttetAttention-deficit Hyperactivity DisorderCanada
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National Taiwan University HospitalAfsluttetAttention-deficit/Hyperactivity Disorder
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National Taiwan University HospitalNational Science Council, TaiwanUkendtAttention Deficit/Hyperactivity DisorderTaiwan
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National Taiwan University HospitalAfsluttetAttention-deficit/Hyperactivity DisorderTaiwan
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University of California, Los AngelesNational Institute of Mental Health (NIMH)RekrutteringAttention-Deficit Hyperactivity DisorderForenede Stater
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Ironshore Pharmaceuticals and Development, IncAfsluttetAttention-Deficit Hyperactivity DisorderForenede Stater
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Florida International UniversityAfsluttetAttention-deficit/Hyperactivity DisorderForenede Stater
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National Taiwan University HospitalUkendtAttention Deficit/Hyperactivity DisorderTaiwan