- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01339286
Associated Genes With Atomoxetine Response in Attention Deficit Hyperactivity Disorder (ADHD)
19 april 2011 uppdaterad av: Peking University
Study of Associated Gene Polymorphisms With Atomoxetine Response Prediction in ADHD Treatment
Attention deficit hyperactivity disorder (ADHD) is the most common behavior disorder, with the prevalence of 3% to 6% in children and adolescents.
The patients' academic achievements, professions and social livings are impaired.
Comorbid antisocial behavior, substance abuse and delinquency burden family and society.
Stimulants used to be the first line drug.
But the medication compliance is poor because of strict drug administration.
Atomoxetine is a new non-stimulant drug, which can effectively improve ADHD symptoms.
But it achieves effect slowly, the drug responses differ significantly, and side effects interfere compliance.
Since genetic factors is the most important cause for different drug responses, this project studies candidate genes potentially associated with atomoxetine medication, with the aim to find 2 to 3 gene polymorphisms influencing the drug response of ADHD.
The study adopts cohort design.
A sample of more than 100 ADHD cases with atomoxetine medication is to be collected.
The rapid genotyping of large sample depends on high-through laboratory.
New statistic method is to be used to improve the sensitivity of the target gene detection.
There has been no such report in country and overseas.
This project will provide basic information for forecasting drug response, improving clinical effects, tolerance and long-term compliance.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
100
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Li Yang, MD PHD
- Telefonnummer: 86-10-62350880
- E-post: lyangli375@126.com
Studieorter
-
-
Beijing
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Beijing, Beijing, Kina, 100191
- Rekrytering
- Peking University Sixth Hospital
-
Kontakt:
- Li Yang, MD PHD
- Telefonnummer: 86-10-62350880
- E-post: lyangli375@126.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
6 år till 16 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- The subject should meet with the DSM-IV ADHD criteria, confirmed by semi-structured interview.
- The subject has not accepted any treatment for ADHD before, or he/she received methylphenidate or atomoxetine treatment but has stopped for 1 or 4 weeks respectively.
- Han Chinese
- Parent sign the informed consent
Exclusion Criteria:
- Who are allergy to atomoxetine
- Who can not complete the titration procedure because of untolerable of the side effect
- Who combined other psychotropic drugs or non-drug intervention for ADHD.
- Children who can not be compliant with the blood withdraw.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: atomoxetine
|
Atomoxetine will be titrated to optimal dose, beginning with 0.5mg/kg.d,
then increasing to 1.2mg/kg.d in two weeks and maintaining for 4 weeks.
If the optimal dose does not achieved, the dose can be increased further to 1.4mg/kg.d
and maintained for 4 weeks.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Investigator Rated)
Tidsram: an expected average of 8 weeks
|
Change from baseline in ADHD Rating Scale: IV (Investigator Rated) after optimal dose treated for 4 weeks
|
an expected average of 8 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Parent Rated)
Tidsram: an expected average of 8 weeks
|
Change from baseline in ADHD Rating Scale: IV (Parent Rated) after optimal dose treated for 4 weeks
|
an expected average of 8 weeks
|
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Teacher Rated)
Tidsram: An expected average of 8 weeks
|
Change from baseline in ADHD Rating Scale: IV (Teacher Rated) after optimal dose treated for 4 weeks
|
An expected average of 8 weeks
|
Improvement of behaviors as rated by IOWA Conners Rating Scale (Parent Rated)
Tidsram: An expected average of 8 weeks
|
Change from baseline in IOWA Conners Rating Scale (Parent Rated) after optimal dose treated for 4 weeks
|
An expected average of 8 weeks
|
Improvement of behaviors as rated by IOWA Conners Rating Scale (Teacher Rated)
Tidsram: An expected average of 8 weeks
|
Change from baseline in IOWA Conners Rating Scale (Teacher Rated) after optimal dose treated for 4 weeks
|
An expected average of 8 weeks
|
Improvement in Clinical Global Impression: Severity
Tidsram: An expected average of 8 weeks
|
Change from baseline in Clinical Global Impression: Severity after optimal dose treated for 4 weeks
|
An expected average of 8 weeks
|
Side effect
Tidsram: An expected average of 8 weeks
|
Number of Subjects with Side effects
|
An expected average of 8 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2011
Primärt slutförande (Förväntat)
1 december 2011
Studieregistreringsdatum
Först inskickad
14 april 2011
Först inskickad som uppfyllde QC-kriterierna
19 april 2011
Första postat (Uppskatta)
20 april 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
20 april 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 april 2011
Senast verifierad
1 april 2011
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Sjukdomar i nervsystemet
- Neurologiska manifestationer
- Dyskinesier
- Uppmärksamhetsbrist och störande beteendestörningar
- Neuropsykiatriska funktionsnedsättningar
- Attention Deficit Disorder med hyperaktivitet
- Hyperkinesis
- Läkemedels fysiologiska effekter
- Adrenerga medel
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Neurotransmittorupptagshämmare
- Membrantransportmodulatorer
- Adrenerga upptagshämmare
- Atomoxetinhydroklorid
Andra studie-ID-nummer
- NSFC30800302
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Attention Deficit Hyperactivity Disorder
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University of California, Los AngelesNational Institute of Mental Health (NIMH)RekryteringAttention-Deficit Hyperactivity DisorderFörenta staterna
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Ironshore Pharmaceuticals and Development, IncAvslutadAttention-Deficit Hyperactivity DisorderFörenta staterna
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Florida International UniversityAvslutadAttention-deficit/Hyperactivity DisorderFörenta staterna
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National Taiwan University HospitalOkändAttention Deficit/Hyperactivity DisorderTaiwan
-
National Taiwan University HospitalAvslutadAttention-deficit/Hyperactivity DisorderTaiwan
-
Purdue Pharma LPAvslutadAttention Deficit/Hyperactivity DisorderFörenta staterna
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The Hospital for Sick ChildrenEhave; Ontario Brain InstituteAvslutadAttention-deficit Hyperactivity DisorderKanada
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National Taiwan University HospitalAvslutadAttention-deficit/Hyperactivity Disorder
-
National Taiwan University HospitalNational Science Council, TaiwanOkändAttention Deficit/Hyperactivity DisorderTaiwan
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National Taiwan University HospitalAvslutadAttention-deficit/Hyperactivity DisorderTaiwan
Kliniska prövningar på atomoxetine
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Boehringer IngelheimRekryteringAttention Deficit Hyperactivity DisorderTyskland
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Eli Lilly and CompanyAvslutadAttention Deficit Hyperactivity Disorder | TrotssyndromItalien
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University of California, Los AngelesNational Institute on Drug Abuse (NIDA)AvslutadMetamfetaminberoende | MetamfetaminmissbrukFörenta staterna
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Brigham and Women's HospitalHar inte rekryterat ännu
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ApnimedAvslutadObstruktiv sömnapnéFörenta staterna
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Children's Hospital Los AngelesBaylor College of Medicine; Children's Hospital of Philadelphia; Children... och andra samarbetspartnersAvslutadDjup ventrombosFörenta staterna
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University of California, San FranciscoAvslutadFeokromocytom | ParagangliomFörenta staterna
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Seoul National University HospitalKyung Hee University Hospital at GangdongAvslutadNeurogen ortostatisk hypotensionKorea, Republiken av
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Lindner Center of HOPEUniversity of CincinnatiAvslutad
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Yale UniversityAvslutadKokainberoende | OpiatberoendeFörenta staterna