1/2-MC4R genotype og pædiatrisk antipsykotisk lægemiddel-induceret vægtøgning
6. januar 2016 opdateret af: Anil K. Malhotra, Northwell Health
Vi vil udføre et 12-ugers, randomiseret åbent studie, hvor vi sammenligner normal pleje (UC) antipsykotisk behandling (aripiprazol, quetiapin, risperidon) med ziprasidon (ZIP) hos børn og unge i alderen 13-18 år.
Patienter vil have 10 dage eller mindre livstidseksponering for antipsykotisk medicin og være i klinisk behov for antipsykotisk behandling for en pædiatrisk psykiatrisk lidelse med FDA indikation for antipsykotisk brug, dvs. bipolar mani, skizofreni-spektrum lidelser og irritabilitet forbundet med autistisk lidelse.
Derudover vil vi også inkludere unge, der opfylder forskningsdiagnostiske kriterier for svær humørdysregulering (SMD).
Randomisering vil blive stratificeret af høj vs. lav genetisk risiko for antipsykotisk induceret vægtøgning baseret på MC4R-genotype, og det primære resultat vil være vægtændring fra baseline til endepunkt mellem ZIP og UC antipsykotisk behandling i hver af de to genotypegrupper.
Som beskrevet nedenfor vil andre metaboliske og hjertesikkerhedsparametre også blive målt og sammenlignet på tværs af behandlinger i hver af genotypegrupperne.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
14
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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New York
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Glen Oaks, New York, Forenede Stater, 11004
- Zucker Hillside Hospital, Psychiatry Research
-
-
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
13 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- alder 13-18 år
- Engelsktalende
- DSM-diagnoser, der har en FDA-indikation for SGA-brug for mindst ét middel i den respektive pædiatriske eller voksne aldersgruppe. Specifikt primær DSM-IV diagnose af tidligt indsættende skizofreni spektrum lidelser; bipolar I lidelse mani (og BP-NOS); irritabilitet forbundet med autismespektrumforstyrrelse, samt alvorlig stemningsdysregulering (SMD) ifølge Leibenluft et al. (2011) med en ABC-irritabilitetsscore på >/=18 Seksuelt aktive piger skal acceptere at bruge to effektive former for prævention eller være afholdende
- Deltageren har en primær vicevært, der har kendt barnet godt i mindst 6 måneder før studiestart Primær vicevært kan deltage i studieaftaler
- Barnets evne til at deltage i alle aspekter af protokollen pr. undersøgers kliniske vurdering.
Ekskluderingskriterier:
- Større neurologiske eller medicinske sygdomme, der påvirker vægten (f.eks. ustabil skjoldbruskkirtelsygdom), kræver en forbudt systemisk medicin (f.eks. diabetes mellitus [insulin], kronisk nyresvigt [steroider); Fastende glukose > 125 mg/dL ved 2 lejligheder under screening
- Enhver medicin (bortset fra den i øjeblikket ordinerede psykotrope medicin), der ville ændre vægten væsentligt
- Antidepressiva ikke tilladt i mindst 2 uger hos BP-I eller BP-NOS patienter
- DSM-IV diagnose af anoreksi eller bulimia nervosa
- DSM-IV-diagnose af stofafhængighedsforstyrrelse (bortset fra tobaksafhængighed) inden for den seneste måned
- Indledende urintoksikologisk screening og opfølgningsskærm indikerer igangværende brug af ulovligt stof
- Overfølsomhed over for ZIP eller UC antipsykotika
- Gravid, ammende eller uvillig til at overholde præventionskrav
- Screening eller baseline QTc > 450 msek
- IQ < 55
- Betydelig risiko for fare for dig selv eller andre
- Igangværende eller tidligere uoplyst børnemishandling, der kræver ny afdeling for social serviceindsats.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Ziprasidon
(20-160mg/d, bud) i 12 uger
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tilfældig tildeling til ZIP (20-160 mg/d, buddosering)
Andre navne:
|
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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 uger
|
tilfældig tildeling til Usual Care antipsykotisk UC antipsykotikum (aripiprazol 2-30mg/d, quetiapin 25-800mg/d eller risperidon 0,1-8mg/d)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Vægtændring
Tidsramme: baseline til uge 12
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baseline til uge 12
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Procent vægtændring sammenlignet med baselinevægt
Tidsramme: baseline til uge 12
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baseline til uge 12
|
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BMI Z-score
Tidsramme: baseline til uge 12
|
baseline til uge 12
|
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BMI Percentil
Tidsramme: baseline til uge 12
|
baseline til uge 12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
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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
1. juli 2013
Primær færdiggørelse (Faktiske)
1. april 2014
Studieafslutning (Faktiske)
1. april 2014
Datoer for studieregistrering
Først indsendt
29. april 2013
Først indsendt, der opfyldte QC-kriterier
30. april 2013
Først opslået (Skøn)
1. maj 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. februar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. januar 2016
Sidst verificeret
1. januar 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Kropsvægt
- Ændringer i kropsvægt
- Vægtøgning
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Antipsykotiske midler
- Beroligende midler
- Psykotropiske stoffer
- Serotoninmidler
- Antidepressive midler
- Dopaminagonister
- Dopaminmidler
- Serotonin 5-HT1-receptoragonister
- Serotoninreceptoragonister
- Serotonin 5-HT2-receptorantagonister
- Serotonin-antagonister
- Dopamin D2-receptorantagonister
- Dopamin-antagonister
- Aripiprazol
- Quetiapinfumarat
- Risperidon
- Ziprasidon
Andre undersøgelses-id-numre
- 12-403A
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 .
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