Open-label undersøgelse af intramuskulært olanzapin depot hos patienter med skizofreni eller skizoaffektiv lidelse
9. december 2011 opdateret af: Eli Lilly and Company
En åben-label undersøgelse af intramuskulært olanzapin-depot hos patienter med skizofreni eller skizoaffektiv lidelse
Dette er et langsigtet, åbent klinisk studie designet til at muliggøre længerevarende behandling af patienter, der afslutter andre kliniske studier med intramuskulært olanzapin-depot.
Hovedmålene med undersøgelsen er at:
- Bestem, hvor godt intramuskulært (IM) olanzapin depot virker under langtidsbehandling,
- Evaluer sikkerheden og tolerabiliteten af IM olanzapin depot under langtidsbehandling,
- Bestem blodniveauerne af IM olanzapin depot hos patienter under langtidsbehandling
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
931
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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Buenos Aires, Argentina, 1221
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Lanus Este, Argentina, B18241BR
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Mendoza, Argentina, M5500GAC
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Queensland
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Herston, Queensland, Australien, 4029
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South Australia
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Glenside, South Australia, Australien, 5065
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Victoria
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Dandenong, Victoria, Australien, 3175
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Diest, Belgien, 3290
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Liège, Belgien, 4000
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Aparecida De Goiania, Brasilien, 74922-810
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Rio De Janeiro, Brasilien, 21020-130
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Salvador, Brasilien, 40301500
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Moscow, Den Russiske Føderation, 115522
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Saint Petersburg, Den Russiske Føderation, 194044
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California
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Orange, California, Forenede Stater, 92868
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Pasadena, California, Forenede Stater, 91107
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San Diego, California, Forenede Stater, 92123
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Santa Ana, California, Forenede Stater, 92705
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20016
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Florida
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Bradenton, Florida, Forenede Stater, 34208
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96826
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Illinois
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Chicago, Illinois, Forenede Stater, 60640
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46222
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Louisiana
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Lake Charles, Louisiana, Forenede Stater, 70601
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Missouri
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St Louis, Missouri, Forenede Stater, 63118
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89102
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Reno, Nevada, Forenede Stater, 89512
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87131
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New York
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Cedarhurst, New York, Forenede Stater, 11516
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New York, New York, Forenede Stater, 10035
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Rochester, New York, Forenede Stater, 14624
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Ohio
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Chagrin Falls, Ohio, Forenede Stater, 44022
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Chardon, Ohio, Forenede Stater, 44024
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Texas
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Houston, Texas, Forenede Stater, 77007
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Washington
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Kirkland, Washington, Forenede Stater, 98033
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Bayonne, Frankrig, 64109
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Bourg En Bresse, Frankrig, 01000
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Dijon, Frankrig, 21033
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Dole, Frankrig, 39100
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Fontaine, Frankrig, 38600
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La Roche Sur Foron, Frankrig, 74800
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La Seyne Sur Mer, Frankrig, 83500
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Limoges, Frankrig, 87025
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Narbonne, Frankrig, 11108
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Paris, Frankrig, 75674
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Saint Cyr Au Mont D'Or, Frankrig, 69450
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Strasbourg, Frankrig, 67000
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Suresnes, Frankrig, 92150
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Den Haag, Holland, 2553 RJ
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Enschede, Holland, 7546 TA
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Beer Yaacov, Israel, 70350
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Hod-Hasharon, Israel, 45100
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Lev Hasharon, Israel, 42100
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Firenze, Italien, 50134
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Savigliano, Italien, 12038
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Torino, Italien, 10126
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Zagreb, Kroatien, 10000
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Guadalajara, Mexico, 45170
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Mexico City, Mexico, 14420
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Monterrey, Mexico, 64000
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Gdynia, Polen, 81-361
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Torun, Polen, 87 100
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Braga, Portugal, 4710-200
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Coimbra, Portugal, 3031801
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Lisbon, Portugal, 1169053
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Porto, Portugal, 4200-272
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Mayaguez, Puerto Rico, 00680
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Ponce, Puerto Rico, 00716
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Rio Piedras, Puerto Rico, 00926
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San Juan, Puerto Rico, 00918
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Bucharest, Rumænien, 73120
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Craiova, Rumænien, 200738
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Iasi, Rumænien, 700282
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Bratislava, Slovakiet, 826 06
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Barcelona, Spanien, 08500
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Burgos, Spanien, 09006
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Málaga, Spanien, 29010
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Sevilla, Spanien, 41700
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Falköping, Sverige, 52185
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Stockholm, Sverige, 11895
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George, Sydafrika, 6530
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Randburg, Sydafrika, 2125
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Taipei, Taiwan, 112
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Tao-Yuan, Taiwan, 333
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Prague, Tjekkiet, 181 03
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Bad Saarow, Tyskland, D-15526
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Berlin, Tyskland, 10117
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Halle, Tyskland, D-06097
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hamburg, Tyskland, D-20251
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mainz, Tyskland, D-55101
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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München, Tyskland, D-81675
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Budapest, Ungarn, 1083
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wien, Østrig, 1010
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 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
18 år til 76 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Patienter skal have skizofreni
- Kvindelige patienter i den fødedygtige alder skal bruge en medicinsk accepteret prævention
- Patienter skal have gennemført (inden for 10 dage) endnu et IM olanzapin depotundersøgelse, hvis det er tilladt i henhold til denne undersøgelses protokol.
Ekskluderingskriterier:
- Patienter må ikke have deltaget i et klinisk forsøg med et andet forsøgslægemiddel, inklusive olanzapin, inden for 1 måned (30 dage) før studiestart
- Kvindelige patienter må ikke være gravide eller ammende
- Patienter må ikke opleve akutte, alvorlige eller ustabile medicinske tilstande bortset fra skizofreni eller skizoaffektiv lidelse
- Patienter må ikke have en stofafhængighed (undtagen nikotin eller koffein) inden for de seneste 30 dage
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: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intramuskulært Olanzapin Depot
Intramuskulær (IM) olanzapin depot fleksibel dosering og fleksibelt interval
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45-405 milligram (mg), intramuskulær injektion, med et 2-, 3- eller 4-ugers interval.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Antal deltagere med uønskede hændelser (AE)
Tidsramme: Randomisering til afslutning af studiet op til 76 måneder
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Listen over alvorlige bivirkninger (SAE) og andre ikke-alvorlige bivirkninger (AE) er i afsnittet om bivirkninger.
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Randomisering til afslutning af studiet op til 76 måneder
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Antal deltagere med behandlingsfremkaldt unormalt højt prolaktin på ethvert tidspunkt efter baseline
Tidsramme: Randomisering til afslutning af studiet op til 76 måneder
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Normalreferenceintervaller for prolactin for kvinder: 2,0 - 29,0 nanogram pr. milliliter (ng/mL); han: 2,0 - 20,0 ng/ml.
Høj værdi defineres som en ændring fra en værdi mindre end eller lig med den høje grænse ved alle baselinebesøg til en værdi større end den høje grænse på et hvilket som helst tidspunkt efter baseline.
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Randomisering til afslutning af studiet op til 76 måneder
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Antal deltagere med behandlingsfremkaldt unormal høj alanintransaminase (ALT), høj aspartattransaminase (AST), høj total bilirubin på ethvert tidspunkt efter baseline
Tidsramme: Randomisering til afslutning af studiet op til 76 måneder
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Høj ALAT er defineret som en baselineværdi på <3 gange den øvre grænse for normal (ULN) til ≥3 gange ULN på ethvert tidspunkt efter baseline.
Høj AST er defineret som en baselineværdi på <5 gange ULN til ≥5 gange ULN på ethvert tidspunkt efter baseline.
Høj total bilirubin er defineret som en baselineværdi på <2 gange ULN til ≥2 gange ULN på et hvilket som helst tidspunkt efter baseline.
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Randomisering til afslutning af studiet op til 76 måneder
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Antal deltagere, der har normal fastende baseline glukoseværdi med behandlingsfremkaldende høj fastende glukose til enhver tid efter baseline
Tidsramme: Randomisering til afslutning af studiet op til 76 måneder
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Normal til høj fastende glukose ≤100 milligram pr. deciliter (mg/dL) ved baseline til ≥126 mg/dL når som helst efter baseline.
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Randomisering til afslutning af studiet op til 76 måneder
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Antal deltagere, der har normal fastende baseline lipidværdi med behandlingsfremkaldende høj fastende lipid til enhver tid efter baseline
Tidsramme: Randomisering til afslutning af studiet op til 76 måneder
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Normalt til højt fastende totalkolesterol ≤200 mg/dL ved baseline til ≥240 mg/dL når som helst efter baseline.
Fastende triglycerider <150 mg/dL ved baseline til ≥200 mg/dL og <500 mg/dL når som helst efter baseline.
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Randomisering til afslutning af studiet op til 76 måneder
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Ændring fra baseline i vægt ved endepunkt for måned 76
Tidsramme: Baseline, op til 76 måneder
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Gennemsnitlig ændring i vægt fra baseline til endepunkt for sidste observation overført (LOCF).
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Baseline, op til 76 måneder
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Antal deltagere med potentielt klinisk signifikant (PCS) vægtøgning ved måned 76 Slutpunkt
Tidsramme: Randomisering til afslutning af studiet op til 76 måneder
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PCS vægtforøgelse er defineret som en ≥7 % stigning i vægt fra baseline.
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Randomisering til afslutning af studiet op til 76 måneder
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Antal deltagere med ekstrapyramidale symptomer til enhver tid
Tidsramme: Randomisering til afslutning af studiet op til 76 måneder
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Ekstrapyramidale symptomer er defineret som Simpson-Angus total score (SAS) >3 ved ethvert post-baseline besøg; Barnes Akathisia Scale (BAS) global score ≥2 ved ethvert post-baseline besøg; En score ≥3 for enhver af Abnormal Involuntary Movement Scale (AIMS) for punkter 1-7 eller en score ≥2 for en hvilken som helst af disse punkter.
Score for SAS er 0-4 for hvert af de 10 spørgsmål, med 0=normal og 4=ekstrem.
Den mulige samlede score for SAS er 0-40.
Mulig score for BAS er 0-5, med 0=fraværende og 5=afbrydelse.
Score 0-4 for hvert emne i AIMS, med 0 = ingen og 4 = sever.
Mulig totalscore for punkt 1-7 er 0-28.
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Randomisering til afslutning af studiet op til 76 måneder
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Ændring fra baseline i positiv og negativ syndromskala (PANSS) samlede resultater ved endepunkt for måned 76
Tidsramme: Baseline, op til 76 måneder
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Vurderer de positive symptomer, negative symptomer og generel psykopatologi specifikt forbundet med skizofreni.
Skalaen består af 30 genstande.
Hvert element er vurderet på en skala fra 1 (symptom ikke til stede) til 7 (symptomer ekstremt alvorlige).
Summen af de 30 elementer er defineret som PANSS' samlede score og varierer fra 30 til 210.
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Baseline, op til 76 måneder
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Ændring fra baseline i PANSS positive resultater ved endepunkt for måned 76
Tidsramme: Baseline, op til 76 måneder
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PANSS spørgsmål 1-7.
Vurderer positive symptomer forbundet med skizofreni.
7 elementer udgør den positive skala (f.
vrangforestillinger, begrebsmæssig desorganisering og hallucinatorisk adfærd).
Hvert element er vurderet på en skala fra 1 (symptom ikke til stede) til 7 (symptomer ekstremt alvorlige).
Samlede positive subskala-scores varierer fra 7 til 49.
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Baseline, op til 76 måneder
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Ændring fra baseline i PANSS-negative resultater ved endepunkt for måned 76
Tidsramme: Baseline, op til 76 måneder
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PANSS spørgsmål 8-14.
Vurderer negative symptomer forbundet med skizofreni.
7 elementer udgør den negative skala (f.eks.
afstumpet affekt, følelsesmæssig tilbagetrækning, dårlig relation og passiv/apatisk social tilbagetrækning).
Hvert element er vurderet på en skala fra 1 (symptom ikke til stede) til 7 (symptomer ekstremt alvorlige).
Samlede negative subskala-scores varierer fra 7 til 49.
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Baseline, op til 76 måneder
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Ændring fra baseline i PANSS generel psykopatologi-underskala ved måned 76 endepunkt
Tidsramme: Baseline, op til 76 måneder
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PANSS General Psychopathology Subscale er de resterende 16 PANSS-spørgsmål eller PANSS-spørgsmål 15 til og med spørgsmål 30.
Hvert element er vurderet på en skala fra 1 (symptom ikke til stede) til 7 (symptomer ekstremt alvorlige).
Summen af de 16 punkter er defineret som PANSS General Psychopathology Subscales.
Mulig score spænder fra 16 til 112.
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Baseline, op til 76 måneder
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Ændring fra baseline i kliniske globale indtryk-sværhedsgrad af sygdom (CGI-S)-resultater ved endepunkt for måned 72
Tidsramme: Baseline, op til 72 måneder
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Måler sværhedsgraden af sygdom på vurderingstidspunktet sammenlignet med behandlingsstart.
Score varierer fra 1 (normal, slet ikke syg) til 7 (blandt de mest ekstremt syge patienter).
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Baseline, op til 72 måneder
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Ændring fra baseline i Heinrichs-Carpenter Quality of Life Scale (QLS) totalscore ved måned 76 slutpunkt
Tidsramme: Baseline, op til 76 måneder
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Heinrich-Carpenter QLS er en interviewer-vurderet skala, som måler virkningen af negative symptomer på erhvervsmæssig, social og psykologisk funktion hos patienter med skizofreni eller skizoaffektiv lidelse.
Hvert af 21 punkter er vurderet på en skala fra 0 (alvorligt nedsat funktionsevne) til 6 (normal eller tilstrækkelig funktion), for et samlet scoreområde på 0-126.
Resultater præsenteres som ændring i Total score.
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Baseline, op til 76 måneder
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Ændring fra baseline i 36-elementer kortform sundhedsundersøgelse (SF-36) ved måned 76 slutpunkt
Tidsramme: Baseline, op til 76 måneder
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Et selvrapporteret spørgeskema, der består af 36 spørgsmål, der dækker 8 sundhedsdomæner (fysisk funktion, social funktion, kropslige smerter, vitalitet, mental sundhed, rolle-fysisk, rolle-emotionel og generel sundhed).
Hvert domæne scores ved at summere de individuelle elementer og omdanne scorerne til en skala fra 0 til 100, hvor højere score indikerer bedre sundhedsstatus eller funktion.
Det mentale komponentresumé (MCS) og det fysiske komponentresumé (PCS) er blevet konstrueret baseret på de 8 SF-36 domæner.
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Baseline, op til 76 måneder
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Antal psykiatribesøg
Tidsramme: Randomisering til afslutning af studiet op til 76 måneder
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Psykiatribesøg var ambulante besøg hos en psykiater eller psykiatrisk sygeplejerske.
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Randomisering til afslutning af studiet op til 76 måneder
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Indlæggelsesdage
Tidsramme: Randomisering til afslutning af studiet op til 76 måneder
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Dette er det samlede antal dage for alle indlagte patienter, der var indlagt på Almen, Psykiatrisk Afdeling samt Intensiv Afdeling (ICU).
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Randomisering til afslutning af studiet op til 76 måneder
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Ændring fra baseline i subjektivt velvære under neuroleptisk behandling - kort form (SWN-S) ved endepunkt 76. måned
Tidsramme: Baseline, op til 76 måneder
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Subjective Well-Being under Neuroleptic Treatment-Short Form (SWN-S) er en selvvurderet patientskala udviklet til at måle det subjektive velbefindende i de foregående 7 dage for en patient under neuroleptisk behandling.
SWN-S består af 20 varer (hver vare er vurderet fra 1=slet ikke til 6=meget meget).
Mulig samlet score spænder fra 20-120.
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Baseline, op til 76 måneder
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Patienttilfredshed med medicin-spørgeskema-modificeret (PSMQ) ved måned 76 Endpoint
Tidsramme: Randomisering til afslutning af studiet op til 76 måneder
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Selvvurderet skala, der måler patientens niveau af tilfredshed med den nuværende antipsykotiske medicin.
Består af 3 punkter, der vurderer tilfredshed med den nuværende undersøgelsesmedicin (scoret fra 1='meget utilfreds' til 5='meget tilfreds'), præference sammenligner nuværende undersøgelsesmedicin i forhold til tidligere medicin (scoret fra 1='meget foretrækker tidligere medicin' til 5= 'meget foretrækker undersøgelsesmedicin'), og bivirkninger af nuværende undersøgelsesmedicin sammenlignet med tidligere lægemidler (scoret fra 1='meget færre bivirkninger' til 5='meget flere bivirkninger').
Udvalget af mulige scoringer er 3-15.
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Randomisering til afslutning af studiet op til 76 måneder
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Plasma-olanzapinkoncentrationer hos deltagere under langtidsbehandling efter år
Tidsramme: Randomisering til afslutning af studiet op til 76 måneder
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Plasma olanzapin koncentrationer er udtrykt som (nanogram/milliliter)/(milligram/dag) ([ng/ml]/[mg/dag]).
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Randomisering til afslutning af studiet op til 76 måneder
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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
- Atkins S, Detke HC, McDonnell DP, Case MG, Wang S. A pooled analysis of injection site-related adverse events in patients with schizophrenia treated with olanzapine long-acting injection. BMC Psychiatry. 2014 Jan 14;14:7. doi: 10.1186/1471-244X-14-7.
- Peuskens J, Porsdal V, Pecenak J, Handest P, D'yachkova Y, Brousil R, Deberdt W. Schizophrenia symptoms and functioning in patients receiving long-term treatment with olanzapine long-acting injection formulation: a pooled analysis. BMC Psychiatry. 2012 Aug 31;12:130. doi: 10.1186/1471-244X-12-130.
- McDonnell DP, Detke HC, Bergstrom RF, Kothare P, Johnson J, Stickelmeyer M, Sanchez-Felix MV, Sorsaburu S, Mitchell MI. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry. 2010 Jun 10;10:45. doi: 10.1186/1471-244X-10-45.
- Detke HC, McDonnell DP, Brunner E, Zhao F, Sorsaburu S, Stefaniak VJ, Corya SA. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases. BMC Psychiatry. 2010 Jun 10;10:43. doi: 10.1186/1471-244X-10-43.
- McDonnell DP, Landry J, Detke HC. Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study. Int Clin Psychopharmacol. 2014 Nov;29(6):322-31. doi: 10.1097/YIC.0000000000000038.
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. august 2004
Primær færdiggørelse (Faktiske)
1. december 2010
Studieafslutning (Faktiske)
1. december 2010
Datoer for studieregistrering
Først indsendt
26. juli 2004
Først indsendt, der opfyldte QC-kriterier
26. juli 2004
Først opslået (Skøn)
27. juli 2004
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. januar 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. december 2011
Sidst verificeret
1. december 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske processer
- Skizofrenispektrum og andre psykotiske lidelser
- Skizofreni
- Sygdom
- Psykotiske lidelser
- 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
- 5995
- F1D-MC-HGKB (Anden identifikator: Eli Lilly and Company)
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 .