- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01339286
Associated Genes With Atomoxetine Response in Attention Deficit Hyperactivity Disorder (ADHD)
19. april 2011 oppdatert 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.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
100
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Li Yang, MD PHD
- Telefonnummer: 86-10-62350880
- E-post: lyangli375@126.com
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100191
- Rekruttering
- Peking University Sixth Hospital
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Ta kontakt med:
- Li Yang, MD PHD
- Telefonnummer: 86-10-62350880
- E-post: lyangli375@126.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 år til 16 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: atomoxetine
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Investigator Rated)
Tidsramme: an expected average of 8 weeks
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Change from baseline in ADHD Rating Scale: IV (Investigator Rated) after optimal dose treated for 4 weeks
|
an expected average of 8 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Improvement of ADHD symptoms as rated by ADHD Rating Scale: IV (Parent Rated)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: An expected average of 8 weeks
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Change from baseline in Clinical Global Impression: Severity after optimal dose treated for 4 weeks
|
An expected average of 8 weeks
|
Side effect
Tidsramme: An expected average of 8 weeks
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Number of Subjects with Side effects
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An expected average of 8 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2011
Primær fullføring (Forventet)
1. desember 2011
Datoer for studieregistrering
Først innsendt
14. april 2011
Først innsendt som oppfylte QC-kriteriene
19. april 2011
Først lagt ut (Anslag)
20. april 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. april 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. april 2011
Sist bekreftet
1. april 2011
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Sykdommer i nervesystemet
- Nevrologiske manifestasjoner
- Dyskinesier
- Oppmerksomhetssvikt og forstyrrende atferdsforstyrrelser
- Nevroutviklingsforstyrrelser
- Attention Deficit Disorder med hyperaktivitet
- Hyperkinesi
- Fysiologiske effekter av legemidler
- Adrenerge midler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Nevrotransmitter opptakshemmere
- Membrantransportmodulatorer
- Adrenerge opptakshemmere
- Atomoksetinhydroklorid
Andre studie-ID-numre
- NSFC30800302
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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-
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