1/2-MC4R genotype og pediatrisk antipsykotisk legemiddel-indusert vektøkning
6. januar 2016 oppdatert av: Anil K. Malhotra, Northwell Health
Vi vil gjennomføre en 12-ukers, randomisert åpen studie, som sammenligner vanlig behandling (UC) antipsykotisk behandling (aripiprazol, quetiapin, risperidon) med ziprasidon (ZIP) hos barn og ungdom i alderen 13-18 år.
Pasienter vil ha 10 dager eller mindre levetid for antipsykotisk eksponering og være i klinisk behov for antipsykotisk behandling for en pediatrisk psykiatrisk lidelse med FDA-indikasjon for antipsykotisk bruk, dvs. bipolar mani, schizofrenispekterforstyrrelser og irritabilitet forbundet med autistisk lidelse.
I tillegg vil vi også inkludere ungdom som oppfyller forskningsdiagnostiske kriterier for alvorlig stemningssvikt (SMD).
Randomisering vil bli stratifisert av høy vs. lav genetisk risiko for antipsykotisk-indusert vektøkning basert på MC4R-genotype, og det primære resultatet vil være vektendring fra baseline til endepunkt mellom ZIP og UC antipsykotisk behandling i hver av de to genotypegruppene.
Som beskrevet nedenfor vil andre metabolske og hjertesikkerhetsparametere også bli målt og sammenlignet på tvers av behandlinger i hver av genotypegruppene.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
14
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New York
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Glen Oaks, New York, Forente stater, 11004
- Zucker Hillside Hospital, Psychiatry Research
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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
13 år til 18 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inklusjonskriterier:
- alder 13-18 år
- Engelsktalende
- DSM-diagnoser som har en FDA-indikasjon for SGA-bruk for minst ett middel i den respektive pediatriske eller voksne aldersgruppen. Spesielt primær DSM-IV-diagnose av tidlig debuterende schizofrenispektrumforstyrrelser; bipolar I lidelse mani (og BP-NOS); irritabilitet assosiert med autismespekterforstyrrelse, samt alvorlig stemningsdysregulering (SMD) ifølge Leibenluft et al. (2011) med en ABC-irritabilitetsscore på >/=18 Seksuelt aktive jenter må godta å bruke to effektive former for prevensjon eller være avholdende
- Deltaker har en primær vaktmester som har kjent barnet godt i minst 6 måneder før studiestart Primær vaktmester kan delta i studieavtaler
- Barnets evne til å delta i alle aspekter av protokollen per etterforskers kliniske vurdering.
Ekskluderingskriterier:
- Større nevrologiske eller medisinske sykdommer som påvirker vekten (f.eks. ustabil skjoldbruskkjertelsykdom), krever en forbudt systemisk medisinering (f.eks. diabetes mellitus [insulin], kronisk nyresvikt [steroider); Fastende glukose > 125 mg/dL ved 2 anledninger under screening
- Enhver medisin (annet enn foreskrevet psykotrope medisiner) som vil endre vekten betydelig
- Antidepressiva ikke tillatt i minst 2 uker hos BP-I eller BP-NOS pasienter
- DSM-IV diagnose av anoreksi eller bulimia nervosa
- DSM-IV diagnose av rusavhengighet (annet enn tobakksavhengighet) i løpet av den siste måneden
- Innledende urintoksikologisk skjerm og oppfølgingsskjerm indikerer pågående bruk av ulovlig stoff
- Overfølsomhet overfor ZIP eller UC antipsykotika
- Gravid, ammer eller uvillig til å overholde prevensjonskrav
- Screening eller baseline QTc > 450 msek
- IQ < 55
- Betydelig risiko for fare for seg selv eller andre
- Pågående eller tidligere ikke avslørt barnemishandling som krever ny avdeling for sosialtjenesteintervensjon.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Ziprasidon
(20-160mg/d, bud) i 12 uker
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tilfeldig tilordning til ZIP (20-160 mg/d, buddosering)
Andre navn:
|
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Aktiv komparator: Aripiprazol, quetiapin, risperidon
Aripiprazol (2-30mg/d), Quetiapin (25-800mg/d) eller risperidon (0,1-8mg/d) i 12 uker
|
tilfeldig tildeling til Usual Care antipsykotisk UC antipsykotisk (aripiprazol 2-30 mg/d, kvetiapin 25-800 mg/d eller risperidon 0,1-8 mg/d)
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Vektendring
Tidsramme: baseline til uke 12
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baseline til uke 12
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Prosent vektendring sammenlignet med baseline vekt
Tidsramme: baseline til uke 12
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baseline til uke 12
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BMI Z-score
Tidsramme: baseline til uke 12
|
baseline til uke 12
|
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BMI-persentil
Tidsramme: baseline til uke 12
|
baseline til uke 12
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
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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. juli 2013
Primær fullføring (Faktiske)
1. april 2014
Studiet fullført (Faktiske)
1. april 2014
Datoer for studieregistrering
Først innsendt
29. april 2013
Først innsendt som oppfylte QC-kriteriene
30. april 2013
Først lagt ut (Anslag)
1. mai 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
5. februar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. januar 2016
Sist bekreftet
1. januar 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Kroppsvekt
- Endringer i kroppsvekt
- Vektøkning
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Sentralnervesystemdepressiva
- Antipsykotiske midler
- Beroligende midler
- Psykotropiske stoffer
- Serotoninmidler
- Antidepressive midler
- Dopaminagonister
- Dopaminmidler
- Serotonin 5-HT1-reseptoragonister
- Serotoninreseptoragonister
- Serotonin 5-HT2-reseptorantagonister
- Serotonin-antagonister
- Dopamin D2-reseptorantagonister
- Dopaminantagonister
- Aripiprazol
- Quetiapinfumarat
- Risperidon
- Ziprasidon
Andre studie-ID-numre
- 12-403A
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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