- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00091650
Olanzapin hos patienter med borderline personlighedsforstyrrelse
21. juli 2006 opdateret af: Eli Lilly and Company
Effekt og sikkerhed af olanzapin hos patienter med borderline personlighedsforstyrrelse: en randomiseret fleksibel dosis dobbeltblind sammenligning med placebo
Målet med denne undersøgelse er at bestemme: sikkerheden af olanzapin og eventuelle bivirkninger, der kan være forbundet med det, hvordan olanzapin sammenlignes med placebo, om olanzapin kan hjælpe patienter med symptomer på borderline personlighedsforstyrrelse (BPD), og hvor meget olanzapin bør gives til patienterne.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding
300
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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Brussels, Belgien
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Kortenberg, Belgien
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Liege, Belgien
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Nieuwkerken-Waas, Belgien
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Tielt, Belgien
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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London, Det Forenede Kongerige
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Georgia
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Atlanta, Georgia, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Marietta, Georgia, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Minnesota
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Minneapolis, Minnesota, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Nevada
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Las Vegas, Nevada, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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North Dakota
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Bismarck, North Dakota, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Pennsylvania
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Media, Pennsylvania, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Virginia
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Charlottesville, Virginia, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Virginia Beach, Virginia, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Washington
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Bellevue, Washington, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Bordeaux Cedex, Frankrig
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Bully Les Mines, Frankrig
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Colombes Cedex, Frankrig
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Dijon Cedex, Frankrig
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Le Kremlin Bicetre, Frankrig
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Marseille Cedex 09, Frankrig
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Nimes Cedex 4, Frankrig
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Paris, Frankrig
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Sceaux, Frankrig
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Toulouse, Frankrig
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Brattvag, Norge
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Oslo, Norge
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Lisbon, Portugal
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Porto, Portugal
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Barcelona, Spanien
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Madrid, Spanien
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Alvsjo, Sverige
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Stockholm, Sverige
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Aachen, Tyskland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Berlin, Tyskland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Freiburg, Tyskland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Mannheim, Tyskland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Rostock, Tyskland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Stralsund, Tyskland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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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
15 år til 65 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Patienter skal være ambulant ved besøg 1 og gennem besøg 2.
- Patienter skal være 15 til 65 år ved besøg 1.
- Patienter skal opfylde alle DSM-IV-TR generelle diagnostiske kriterier for en personlighedsforstyrrelse, og patienter skal opfylde DSM-IV-TR diagnostiske kriterier for BPD.
- Symptomsværhedsgraden vurderet ved den samlede score for ZAN-BPD, bekræftet af en psykiater med uddannelse i evaluering og vurdering af BPD, skal være større end eller lig med 9 ved besøg 2.
- Kvindelige patienter i den fødedygtige alder skal teste negativ for graviditet og skal bruge en medicinsk accepteret præventionsmetode under hele undersøgelsens forløb.
Ekskluderingskriterier:
- Patienter må ikke være investigatorer, personale på undersøgelsesstedet, der er direkte tilknyttet undersøgelsen, eller den nærmeste familie af investigatorpersonale, der er direkte tilknyttet undersøgelsen. Nærmeste familie defineres som en ægtefælle, forælder, barn eller søskende, uanset om det er biologisk eller lovligt adopteret.
- Personer ansat af Lilly (det vil sige ansatte, midlertidige kontraktansatte eller udpegede personer, der er ansvarlige for gennemførelsen af undersøgelsen). Den nærmeste familie til Lilly-ansatte kan deltage i Lilly-sponsorerede kliniske forsøg, men har ikke tilladelse til at deltage på en Lilly-facilitet. Nærmeste familie defineres som en ægtefælle, forælder, barn eller søskende, uanset om det er biologisk eller lovligt adopteret.
- Patienter må ikke tidligere have deltaget (være blevet randomiseret) eller trukket sig fra denne undersøgelse eller nogen anden Lilly-sponsoreret undersøgelse, der undersøger olanzapin.
- Patienter må ikke have haft tidligere behandling med olanzapin, medmindre efter investigatorens opfattelse patienternes tidligere behandling var utilstrækkelig i dosis eller varighed til at give en nøjagtig vurdering af behandlingen, eller effekten af olanzapin blev forvirret ved samtidig medicinering.
- Kvindelige patienter må ikke være gravide eller ammende.
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
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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At vurdere effekten af olanzapinbehandling (2,5 til 20,0 mg/dag) sammenlignet med placebo hos patienter over eller
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lig med 18 års alder, med en diagnose af BPD som defineret af DSM-IV-TR kriterier, for at forbedre den overordnede symptomatologi målt ved den gennemsnitlige sidste observation
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fremført (LOCF) ændring i ZAN-BPD
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samlet score i op til 12 ugers dobbeltblind behandling.
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Sekundære resultatmål
Resultatmål |
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At vurdere virkningseffekten af olanzapinbehandling (2,5 til 20,0 mg/dag) sammenlignet med placebo hos patienter over eller lig med 15 år og under 18 år
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med BPD, som defineret af DSM-IV-TR-kriterier, for at forbedre den overordnede symptomatologi målt ved den gennemsnitlige LOCF-ændring i ZAN-BPD-totalscore i op til 12 ugers dobbeltblind behandling.
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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.
Generelle publikationer
- Houston J, Dharia S, Bishop JR, Ellingrod VL, Fijal B, Jacobson JG, Hoffmann VP. Association of DRD2 and ANKK1 polymorphisms with prolactin increase in olanzapine-treated women. Psychiatry Res. 2011 May 15;187(1-2):74-9. doi: 10.1016/j.psychres.2010.10.020. Epub 2010 Nov 20.
- Houston JP, Kohler J, Bishop JR, Ellingrod VL, Ostbye KM, Zhao F, Conley RR, Poole Hoffmann V, Fijal BA. Pharmacogenomic associations with weight gain in olanzapine treatment of patients without schizophrenia. J Clin Psychiatry. 2012 Aug;73(8):1077-86. doi: 10.4088/JCP.11m06916.
- Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
- Schulz SC, Zanarini MC, Bateman A, Bohus M, Detke HC, Trzaskoma Q, Tanaka Y, Lin D, Deberdt W, Corya S. Olanzapine for the treatment of borderline personality disorder: variable dose 12-week randomised double-blind placebo-controlled study. Br J Psychiatry. 2008 Dec;193(6):485-92. doi: 10.1192/bjp.bp.107.037903.
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. marts 2004
Studieafslutning
1. november 2005
Datoer for studieregistrering
Først indsendt
14. september 2004
Først indsendt, der opfyldte QC-kriterier
24. september 2004
Først opslået (Skøn)
27. september 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. juli 2006
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juli 2006
Sidst verificeret
1. juli 2006
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Personlighedsforstyrrelser
- Borderline personlighedsforstyrrelse
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Autonome agenter
- Agenter fra det perifere nervesystem
- Antiemetika
- Gastrointestinale midler
- Antipsykotiske midler
- Beroligende midler
- Psykotropiske stoffer
- Serotoninoptagelseshæmmere
- Neurotransmitter optagelseshæmmere
- Membrantransportmodulatorer
- Serotoninmidler
- Olanzapin
Andre undersøgelses-id-numre
- 6257
- F1D-MC-HGKL
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 Olanzapin
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Assistance Publique Hopitaux De MarseilleAfsluttet
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Veterans Medical Research FoundationBristol-Myers SquibbAfsluttet
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Eli Lilly and CompanyAfsluttetSkizofrene lidelserKalkun, Finland
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Vanderbilt UniversityEli Lilly and CompanyAfsluttet
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Eli Lilly and CompanyAfsluttetSkizofreniForenede Stater, Puerto Rico, Spanien, Rumænien, Canada, Frankrig, Argentina, Brasilien, Grækenland, Portugal, Slovakiet, Taiwan
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The Mind Research NetworkAfsluttet
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Alkermes, Inc.AfsluttetSkizofreni | AlkoholbrugsforstyrrelseForenede Stater, Bulgarien, Polen
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Centre for Addiction and Mental HealthUniversity Health Network, TorontoRekruttering
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Eli Lilly and CompanyAfsluttetSkizofreni | Skizoaffektiv lidelse | ManiodepressivForenede Stater, Puerto Rico, Holland, Canada, Mexico
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Amani Hassan Abdel-WahabAfsluttet