- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00018863
Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)
30. november 2020 opdateret af: Laurence Greenhill, New York State Psychiatric Institute
Methylphenidate Efficacy and Safety in ADHD Preschoolers
This research focuses on the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in very young children.
The medication being used is methylphenidate (Ritalin); it is being studied to determine its safety and how well it works to treat ADHD in preschool-age children (3-5.5 year olds).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Young children age 3-5.5 years will be studied.
The study includes treatment with different doses of methylphenidate and placebo; all children will receive active medication during the study.
Prior to treatment, each child will receive a thorough psychiatric evaluation and each guardian will complete a 10-week workshop (2 hours/week).
Throughout the study, parents and teachers will complete forms that report on the child's behavior and possible side effects.
Participants will be monitored by regular visits with a study physician.
Most participants will be involved in the study for up to 16 months to ensure optimal evaluation, dosing, and monitoring
Undersøgelsestype
Interventionel
Tilmelding
165
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Irvine, California, Forenede Stater
- University of California, Irvine
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Los Angeles, California, Forenede Stater
- University of California, Los Angeles
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Maryland
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Baltimore, Maryland, Forenede Stater
- Johns Hopkins University
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New York
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New York, New York, Forenede Stater
- New York State Psychiatric Institute
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New York, New York, Forenede Stater
- New York University School of Medicine
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North Carolina
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Durham, North Carolina, Forenede Stater
- Duke University Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
3 år til 5 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Boys and girls who are:
- Between the ages of 3-5.5 years
- Qualified as having ADHD by our diagnostic evaluations and clinical staff
- Otherwise generally healthy
- Willing, and have parents that are willing, to attend all visits required by the study
- Enrolled in some type of day-program: day care, preschool, nursery school, kindergarten, for at least 2 half days/week
- In classrooms with teachers that are willing to participate by completing rating scale
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Maskning: Dobbelt
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Laurence Greenhill, M.D.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Schleifer M, Weiss G, Cohen N, Elman M, Cvejic H, Kruger E. Hyperactivity in preschoolers and the effect of methylphenidate. Am J Orthopsychiatry. 1975 Jan;45(1):38-50. doi: 10.1111/j.1939-0025.1975.tb01164.x.
- Handen BL, Feldman HM, Lurier A, Murray PJ. Efficacy of methylphenidate among preschool children with developmental disabilities and ADHD. J Am Acad Child Adolesc Psychiatry. 1999 Jul;38(7):805-12. doi: 10.1097/00004583-199907000-00009.
- Conners CK: Controlled trial of methylphenidate in preschool children with minimal brain dysfunction. Int J Ment Health (4):61-74, 1975.
- Barkley RA. The effects of methylphenidate on the interactions of preschool ADHD children with their mothers. J Am Acad Child Adolesc Psychiatry. 1988 May;27(3):336-41. doi: 10.1097/00004583-198805000-00012. No abstract available.
- Mayes SD, Crites DL, Bixler EO, Humphrey FJ 2nd, Mattison RE. Methylphenidate and ADHD: influence of age, IQ and neurodevelopmental status. Dev Med Child Neurol. 1994 Dec;36(12):1099-107. doi: 10.1111/j.1469-8749.1994.tb11811.x.
- Musten LM, Firestone P, Pisterman S, Bennett S, Mercer J. Effects of methylphenidate on preschool children with ADHD: cognitive and behavioral functions. J Am Acad Child Adolesc Psychiatry. 1997 Oct;36(10):1407-15. doi: 10.1097/00004583-199710000-00023.
- Kollins S, Greenhill L, Swanson J, Wigal S, Abikoff H, McCRACKEN J, Riddle M, McGOUGH J, Vitiello B, Wigal T, Skrobala A, Posner K, Ghuman J, Davies M, Cunningham C, Bauzo A. Rationale, design, and methods of the Preschool ADHD Treatment Study (PATS). J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1275-1283. doi: 10.1097/01.chi.0000235074.86919.dc.
- Swanson J, Greenhill L, Wigal T, Kollins S, Stehli A, Davies M, Chuang S, Vitiello B, Skrobala A, Posner K, Abikoff H, Oatis M, McCRACKEN J, McGOUGH J, Riddle M, Ghuman J, Cunningham C, Wigal S. Stimulant-related reductions of growth rates in the PATS. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1304-1313. doi: 10.1097/01.chi.0000235075.25038.5a.
- Greenhill L, Kollins S, Abikoff H, McCracken J, Riddle M, Swanson J, McGough J, Wigal S, Wigal T, Vitiello B, Skrobala A, Posner K, Ghuman J, Cunningham C, Davies M, Chuang S, Cooper T. Efficacy and safety of immediate-release methylphenidate treatment for preschoolers with ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1284-1293. doi: 10.1097/01.chi.0000235077.32661.61. Erratum In: J Am Acad Child Adolesc Psychiatry. 2007 Jan;46(1):141.
- McGOUGH J, McCRACKEN J, Swanson J, Riddle M, Kollins S, Greenhill L, Abikoff H, Davies M, Chuang S, Wigal T, Wigal S, Posner K, Skrobala A, Kastelic E, Ghuman J, Cunningham C, Shigawa S, Moyzis R, Vitiello B. Pharmacogenetics of methylphenidate response in preschoolers with ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1314-1322. doi: 10.1097/01.chi.0000235083.40285.08.
- Wigal T, Greenhill L, Chuang S, McGOUGH J, Vitiello B, Skrobala A, Swanson J, Wigal S, Abikoff H, Kollins S, McCRACKEN J, Riddle M, Posner K, Ghuman J, Davies M, Thorp B, Stehli A. Safety and tolerability of methylphenidate in preschool children with ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1294-1303. doi: 10.1097/01.chi.0000235082.63156.27.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2001
Primær færdiggørelse (Faktiske)
31. marts 2006
Studieafslutning (Faktiske)
30. november 2006
Datoer for studieregistrering
Først indsendt
5. juli 2001
Først indsendt, der opfyldte QC-kriterier
6. juli 2001
Først opslået (Skøn)
9. juli 2001
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. december 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Sygdomme i nervesystemet
- Neurologiske manifestationer
- Dyskinesier
- Opmærksomhedsunderskud og forstyrrende adfærdsforstyrrelser
- Neuroudviklingsforstyrrelser
- Attention Deficit Disorder med hyperaktivitet
- Hyperkinesi
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Neurotransmitter optagelseshæmmere
- Membrantransportmodulatorer
- Dopaminmidler
- Dopaminoptagelseshæmmere
- Centralnervesystemets stimulanser
- Methylphenidat
Andre undersøgelses-id-numre
- #3761
- U01MH060903 (U.S. NIH-bevilling/kontrakt)
- U01MH060642 (U.S. NIH-bevilling/kontrakt)
- U01MH060943 (U.S. NIH-bevilling/kontrakt)
- U01MH060848 (U.S. NIH-bevilling/kontrakt)
- U01MH060900 (U.S. NIH-bevilling/kontrakt)
- U01MH060833 (U.S. NIH-bevilling/kontrakt)
- DSIR CT-M2
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Attention Deficit Disorder med hyperaktivitet
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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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Ornit CohenUkendtAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder med hyperaktivitet | Attention Deficit Disorder | Attention Deficit Disorders med hyperaktivitet | Attention Deficit Hyperactivity DisordersIsrael
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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
Kliniske forsøg med Methylphenidat
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University of ArkansasAfsluttet
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Mahidol UniversityIkke rekrutterer endnu
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Ironshore Pharmaceuticals and Development, IncAfsluttetAttention Deficit Hyperactivity DisorderForenede Stater
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Boston Children's HospitalNational Institute of Mental Health (NIMH)AfsluttetEpilepsi | Attention Deficit Disorder med hyperaktivitetForenede Stater
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Tehran University of Medical SciencesUkendtAttention Deficit Hyperactivity DisorderIran, Islamisk Republik
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Florida International UniversityNational Institute of Mental Health (NIMH)AfsluttetAttention Deficit Disorder med hyperaktivitetForenede Stater
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Massachusetts General HospitalMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC...Afsluttet
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Alza Corporation, DE, USAAfsluttet
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Milton S. Hershey Medical CenterChildren's Miracle NetworkAfsluttetAdfærdsmæssig søvnløshed i barndommen | Attention Deficit Disorder med hyperaktivitetForenede Stater
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Children's Hospital of PhiladelphiaOrtho-McNeil Janssen Scientific Affairs, LLCAfsluttetAttention Deficit Hyperactivity DisorderForenede Stater