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En langsigtet, åben-label undersøgelse om skizofreni

11. januar 2013 opdateret af: Eli Lilly and Company

En langsigtet, open-label, multicenter undersøgelse af LY2140023 sammenlignet med atypisk antipsykotisk behandlingsstandard hos patienter med DSM-IV-TR skizofreni

Det primære formål med undersøgelsen er at hjælpe med at besvare følgende forskningsspørgsmål:

Hvordan LY 2140023 kan tolereres af patienter med skizofreni sammenlignet med standardbehandling i en periode på 52 uger.

Om LY 2140023 kan hjælpe patienter med skizofreni.

Studieoversigt

Status

Afsluttet

Betingelser

Skizofreni

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsen omfatter 2 behandlingsperioder. Studieperiode I vil begynde ved patientrandomisering (tilmelding til Studie HBBO) og fortsætte gennem de første 2 års behandling. Studieperiode II vil kun være for patienter, der er randomiseret til behandling med LY2140023, og vil begynde efter, at patienten har afsluttet det andet behandlingsår. Patienter, der kvalificerer sig til optagelse, vil blive randomiseret i forholdet 3:1 (henholdsvis LY2140023 versus standardbehandling) i 2 behandlingsgrupper: fleksibel dosis LY2140023 to gange dagligt eller standardbehandling (olanzapin, risperidon, aripiprazol eller quetiapin). De, der er tildelt LY2140023, vil have mulighed for at fortsætte på LY2140023 efter 2 år, hvis efterforskeren finder det passende.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

1210

Fase

Fase 2
Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Den Russiske Føderation
- - Khotkovo, Den Russiske Føderation, 127025
    - 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.
  - Lipetsk, Den Russiske Føderation, 399007
    - 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.
  - Moscow, Den Russiske Føderation, 115522
    - 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.
  - Nizhniy Novgorod, Den Russiske Føderation, 603155
    - 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.
  - Saint Petersburg, Den Russiske Føderation, 190121
    - 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.
  - Samara, Den Russiske Føderation, 443016
    - 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.
  - Saratov, Den Russiske Føderation, 410060
    - 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.
  - Tomsk, Den Russiske Føderation, 634014
    - 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.
  - Voronezh, Den Russiske Føderation, 394071
    - 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.
  - Yaroslavl, Den Russiske Føderation, 150003
    - 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.
Forenede Stater
- Arkansas
  - Little Rock, Arkansas, Forenede Stater, 72201
    - 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.
- California
  - Escondido, California, Forenede Stater, 92025
    - 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.
  - Garden Grove, California, Forenede Stater, 92845
    - 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.
  - Long Beach, California, Forenede Stater, 90813
    - 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.
  - National City, California, Forenede Stater, 91950
    - 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.
  - Oakland, California, Forenede Stater, 94612
    - 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.
  - Oceanside, California, Forenede Stater, 92056
    - 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.
  - Paramount, California, Forenede Stater, 90723
    - 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.
  - Pasadena, California, Forenede Stater, 91106
    - 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.
  - San Diego, California, Forenede Stater, 92123
    - 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.
  - Sherman Oaks, California, Forenede Stater, 91403
    - 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.
  - Torrance, California, Forenede Stater, 90502
    - 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.
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 20016
    - 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.
- Florida
  - Fort Lauderdale, Florida, Forenede Stater, 33308
    - 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.
  - Hollywood, Florida, Forenede Stater, 33021
    - 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.
  - Kissimmee, Florida, Forenede Stater, 34741
    - 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.
  - Maitland, Florida, Forenede Stater, 32751
    - 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.
  - University Park, Florida, Forenede Stater, 34201
    - 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.
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30308
    - 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.
- Illinois
  - Chicago, Illinois, Forenede Stater, 60640
    - 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.
  - Hoffman Estates, Illinois, Forenede Stater, 60169
    - 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.
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46222
    - 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.
- Kansas
  - Wichita, Kansas, Forenede Stater, 67207
    - 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.
- Louisiana
  - Lake Charles, Louisiana, Forenede Stater, 70629
    - 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.
  - Shreveport, Louisiana, Forenede Stater, 71104
    - 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.
- Mississippi
  - Flowood, Mississippi, Forenede Stater, 39232
    - 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.
- Missouri
  - Creve Coeur, Missouri, Forenede Stater, 63141
    - 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.
- New Jersey
  - Marlton, New Jersey, Forenede Stater, 08053
    - 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.
- New York
  - Buffalo, New York, Forenede Stater, 14215
    - 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.
  - Cedarhurst, New York, Forenede Stater, 11516
    - 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.
  - Holliswood, New York, Forenede Stater, 11423
    - 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.
  - New York, New York, Forenede Stater, 10032
    - 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.
  - Rochester, New York, Forenede Stater, 14615
    - 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.
- Ohio
  - Cincinnati, Ohio, Forenede Stater, 45219
    - 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.
  - Dayton, Ohio, Forenede Stater, 45417
    - 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.
- Pennsylvania
  - Philadelphia, Pennsylvania, Forenede Stater, 19139
    - 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.
- Texas
  - Austin, Texas, Forenede Stater, 78754
    - 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.
  - Dallas, Texas, Forenede Stater, 75243
    - 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.
  - Desoto, Texas, Forenede Stater, 75115
    - 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.
  - Houston, Texas, Forenede Stater, 77008
    - 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.
- Virginia
  - Richmond, Virginia, Forenede Stater, 23298
    - 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.
  - Roanoke, Virginia, Forenede Stater, 24014
    - 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.
Japan
- - Aichi, Japan, 470-1168
    - 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.
  - Kanagawa, Japan, 210-0013
    - 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.
  - Kumamoto, Japan, 861-0002
    - 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.
  - Kyoto, Japan, 625-8502
    - 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.
  - Nagano, Japan, 384-8540
    - 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.
  - Nagasaki, Japan, 856-0847
    - 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.
  - Nara, Japan, 634-8522
    - 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.
  - Osaka, Japan, 569-1041
    - 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.
  - Saga, Japan, 842-0192
    - 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.
  - Tokyo, Japan, 120-0033
    - 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.
  - Toyama, Japan, 939-8073
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Korea, Republikken
- - Goyang-Si, Korea, Republikken, 410-719
    - 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.
  - Incheon, Korea, Republikken, 400-711
    - 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.
  - Naju, Korea, Republikken, 520-833
    - 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.
  - Seoul, Korea, Republikken, 150-713
    - 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.
  - Suwon-City, Korea, Republikken, 442-723
    - 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.
  - Yongin, Korea, Republikken, 446-769
    - 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.
Kroatien
- - Zagreb, Kroatien, 10090
    - 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.
Mexico
- - Guadalajara, Mexico, 44340
    - 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.
  - Monterrey, Mexico, 64060
    - 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.
Puerto Rico
- - Ponce, Puerto Rico, 00731
    - 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.
  - San Juan, Puerto Rico, 00926
    - 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.
Taiwan
- - Changhua, Taiwan, 50550
    - 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.
  - Neihu Taipei, Taiwan, 114
    - 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.
  - Taipei, Taiwan, 100
    - 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.
Ukraine
- - Donetsk, Ukraine, 83037
    - 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.
  - Kherson, Ukraine, 73488
    - 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.
  - Kiev, Ukraine, 2660
    - 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.
  - Vinnytsya, Ukraine, 21005
    - 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.

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 65 år (VOKSEN, OLDER_ADULT)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inklusionskriterier:

Skal have opfyldt alle adgangskriterier for og have gennemført et akut, placebokontrolleret klinisk forsøg med LY2140023 (såsom undersøgelse H8Y-MC-HBBM eller andre akutte, placebokontrollerede LY2140023 undersøgelser, hvis det er tilladt i henhold til protokollerne for disse undersøgelser) .
Kvindelige patienter i den fødedygtige alder skal acceptere at bruge en enkelt, effektiv, medicinsk acceptabel præventionsmetode.
Patienter skal anses for at være pålidelige og have et tilstrækkeligt forståelsesniveau til at udføre alle test og undersøgelser, der kræves af protokollen.
Patienterne skal være i stand til at forstå undersøgelsens karakter og have givet deres eget informerede samtykke.

Ekskluderingskriterier:

Er i øjeblikket tilmeldt eller afbrudt inden for de sidste 30 dage fra et klinisk forsøg, der involverer et forsøgsprodukt eller ikke-godkendt brug af et lægemiddel eller udstyr (andre end LY2140023), eller samtidig tilmeldt enhver anden form for medicinsk forskning, der vurderes ikke at være videnskabelig eller medicinsk forenelig med denne undersøgelse.
Patienter, for hvem behandling med olanzapin, risperidon, aripiprazol, quetiapin eller LY2140023, som specificeret i denne protokol, er relativt eller absolut klinisk kontraindiceret.
Patienter, der har modtaget behandling med clozapin i doser større end 200 mg dagligt inden for 12 måneder før studieindskrivning, eller som overhovedet har modtaget clozapin i løbet af måneden før studieindskrivning.
Patienter, som kræver samtidig behandling med anden medicin med primær aktivitet i centralnervesystemet, ud over dem, der er tilladt i undersøgelsesprotokollen.
Patienter har risiko for selvmord.
Patienter diagnosticeret med stofafhængighed eller stofmisbrug inden for de 6 måneder forud for studieindskrivning.
Patienter diagnosticeret med stof-induceret psykose inden for 7 dage efter tilmelding til undersøgelsen eller på et hvilket som helst tidspunkt under undersøgelsen.
Kvindelige patienter, der er gravide, ammer, ammer eller har til hensigt at blive gravide inden for 30 dage efter at have afsluttet undersøgelsen.
Har kendt glaukom.
Har en historie med nogle typer anfald.
Har anfaldsansvar, der ikke er i overensstemmelse med udelukkelseskriterierne for den afsluttede akutte feeder-undersøgelse.
Patienter, der har fået elektrokonvulsiv terapi (ECT) inden for 3 måneder efter tilmelding til undersøgelsen, eller som vil have ECT på et hvilket som helst tidspunkt under undersøgelsen.
Patienter med kendt human immundefektvirus positiv (HIV+) status.
Patienter har en alvorlig sygdom, såsom nyligt slagtilfælde, hjerte-, lever-, nyre-, lunge- eller blodsygdomme
Patienter med Parkinsons sygdom
Er ude af stand til at deltage i undersøgelsen eller er uvillige til at engagere sig på en meningsfuld måde som undersøgelsesdeltagere.

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: TILFÆLDIGT
Interventionel model: PARALLEL
Maskning: INGEN

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
ACTIVE_COMPARATOR: Standard for pleje	Medicin: Olanzapin Tabletter eller kapsler, givet oralt, i overensstemmelse med godkendt mærkning og lokal praksis i 104 uger Andre navne: Zyprexa LY170053 Medicin: Aripiprazol Tabletter eller kapsler, givet oralt, i overensstemmelse med godkendt mærkning og lokal praksis i 104 uger Medicin: Risperidon Tabletter eller kapsler, givet oralt, i overensstemmelse med godkendt mærkning og lokal praksis i 104 uger Medicin: Quetiapin Tabletter eller kapsler, givet oralt, i overensstemmelse med godkendt mærkning og lokal praksis i 104 uger
EKSPERIMENTEL: LY2140023 20 mg, 40 mg eller 80 mg Efter 104 uger har patienterne mulighed for at fortsætte behandlingen indtil afslutningen af undersøgelsen	Medicin: LY2140023 Indgivet oralt, to gange dagligt i 104 uger Andre navne: mGlu 2/3 Prodrug II

Deltagergruppe / Arm

Intervention / Behandling

ACTIVE_COMPARATOR: Standard for pleje

Medicin: Olanzapin

Tabletter eller kapsler, givet oralt, i overensstemmelse med godkendt mærkning og lokal praksis i 104 uger

Andre navne:

Zyprexa
LY170053

Medicin: Aripiprazol

Tabletter eller kapsler, givet oralt, i overensstemmelse med godkendt mærkning og lokal praksis i 104 uger

Medicin: Risperidon

Tabletter eller kapsler, givet oralt, i overensstemmelse med godkendt mærkning og lokal praksis i 104 uger

Medicin: Quetiapin

Tabletter eller kapsler, givet oralt, i overensstemmelse med godkendt mærkning og lokal praksis i 104 uger

EKSPERIMENTEL: LY2140023

20 mg, 40 mg eller 80 mg

Efter 104 uger har patienterne mulighed for at fortsætte behandlingen indtil afslutningen af undersøgelsen

Medicin: LY2140023

Indgivet oralt, to gange dagligt i 104 uger

Andre navne:

mGlu 2/3 Prodrug II

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Tid til seponering på grund af uønskede hændelser Tidsramme: Baseline gennem 52 uger	Baseline gennem 52 uger

Sekundære resultatmål

Resultatmål	Tidsramme
Ændring fra baseline til 52 ugers endepunkt i PANSS (Positive and Negative Syndrome Scale) Tidsramme: Baseline, 52 uger	Baseline, 52 uger
Ændring fra baseline til 52 ugers endepunkt i Clinical Global Impression-Severity (CGI-S) Tidsramme: Baseline, 52 uger	Baseline, 52 uger
Ændring fra baseline til 52 ugers endepunkt i NSA-16 (16-punkts vurdering af negative symptomer) Tidsramme: Baseline, 52 uger	Baseline, 52 uger
Antallet af patienter med statistisk signifikante ændringer (behandlingsfremkaldende idéer og adfærd; forbedring) baseret på Columbia Suicide Severity Rating Scale (C-SSRS) Tidsramme: 52 uger, 104 uger, afslutning på studiet	52 uger, 104 uger, afslutning på studiet
Ændring fra baseline til 52 ugers endepunkt i PSP-skala (Personlig og social præstation) Tidsramme: Baseline, 52 uger	Baseline, 52 uger
Ændring fra baseline til 52 ugers endepunkt i SWN-skalaen (subjektivt velvære under neuroleptisk behandling) Tidsramme: Baseline, 52 uger	Baseline, 52 uger
Ændring fra baseline til 104 ugers slutpunkt i Schizofreni Resource Use Model (S-RUM) Tidsramme: Baseline, 104 uger	Baseline, 104 uger
Ændring fra baseline til 104 ugers slutpunkt i EuroQoL Questionnaire-5 Dimension (EQ-5D) Tidsramme: Baseline, 104 uger	Baseline, 104 uger
Ændring fra 52 uger til 104 ugers endepunkt i PANSS (Positive and Negative Syndrome Scale) Tidsramme: 52 uger, 104 uger	52 uger, 104 uger
Ændring fra 52 uger til 104 ugers endepunkt i Clinical Global Impression-Severity (CGI-S) Tidsramme: 52 uger, 104 uger	52 uger, 104 uger
Ændring fra 52 uger til 104 ugers endepunkt i NSA-16 (16-punkts vurdering af negative symptomer) Tidsramme: 52 uger, 104 uger	52 uger, 104 uger
Skift fra 104 uger til undersøgelsesendepunkt i Clinical Global Impression-Severity (CGI-S) Tidsramme: 104 uger, endt studie	104 uger, endt studie
Ændring fra baseline til 104 ugers slutpunkt i PSP-skalaen (Personlig og social præstation) Tidsramme: Baseline, 104 uger	Baseline, 104 uger
Ændring fra baseline til 104 ugers endepunkt i SWN-skalaen (subjektivt velvære under neuroleptisk behandling) Tidsramme: Baseline, 104 uger	Baseline, 104 uger
Ændring fra baseline til 52 ugers slutpunkt i skizofreni-ressourceforbrugsmodellen (S-RUM) Tidsramme: Baseline, 52 uger	Baseline, 52 uger
Skift fra 104 uger til studieendepunkt i EuroQoL Questionnaire-5 Dimension (EQ-5D) Tidsramme: 104 uger, endt studie	104 uger, endt studie
Ændring fra baseline til 52 ugers endepunkt i PANSS (Positive and Negative Syndrome Scale) i en genetisk defineret undergruppe Tidsramme: Baseline, 52 uger	Baseline, 52 uger

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eli Lilly and Company

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. juni 2010

Primær færdiggørelse (FAKTISKE)

1. oktober 2012

Studieafslutning (FAKTISKE)

1. oktober 2012

Datoer for studieregistrering

Først indsendt

21. maj 2010

Først indsendt, der opfyldte QC-kriterier

21. maj 2010

Først opslået (SKØN)

25. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (SKØN)

21. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. januar 2013

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

11960 (Anden identifikator: DAIDS-ES Registry Number)
H8Y-MC-HBBO (ANDET: 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 .

Kliniske forsøg med Olanzapin

Teva Branded Pharmaceutical Products R&D LLC

Afsluttet

Åbent forsøg, der karakteriserer PK af 3 SC Olanzapin formuleringer med forlænget frigivelse hos deltagere med skizofreni/skizoaffektiv lidelse.

Skizofreni, skizoaffektiv lidelse

Forenede Stater
Shandong Cancer Hospital and Institute

Afsluttet

Olanzapin-dosis-sammenligning til forebyggelse af HER-INV: En netværksmeta-analyse

Faste tumorer | Kvalme og opkast | Olanzapin

Kina
Mercy Bon Secours Saint Vincent Medical Center

Rekruttering

Sammenligning af Haloperidol med Olanzapin i behandlingen af mistænkt cannabinoid hyperemesis på skadestuen (CH2O)

Cannabinoid hyperemesis syndrom

Forenede Stater
Centre for Addiction and Mental Health
University Health Network, Toronto

Aktiv, ikke rekrutterende

Intranasal insulin og olanzapin undersøgelse hos raske frivillige (INI/OLA)

Sund kontrol

Canada
Assistance Publique Hopitaux De Marseille

Afsluttet

Specifik antifaktor Xa-aktivitetsdosering for at forbedre påvisning af manglende overholdelse hos patienter med atrieflimren

Atrieflimren
Chinese University of Hong Kong

Rekruttering

Personlig antiemetisk behandlingsplan baseret på patienters farmakogenetiske profil

Brystkræft

Hong Kong
Veterans Medical Research Foundation
Bristol-Myers Squibb

Afsluttet

Akut indvirkning af intramuskulær (IM) aripiprazol og olanzapin på insulinresistens hos højrisiko-prædiabetikere

Diabetes

Forenede Stater
Eli Lilly and Company

Afsluttet

Sammenligning af intramuskulært olanzapindepot med oralt olanzapin og lavdosisdepot hos patienter med skizofreni

Skizofrene lidelser

Kalkun, Finland
University of Sao Paulo

Afsluttet

Behandling af tinnitus med olanzapin (OLANZAP_TIN)

Tinnitus, Subjektiv | Tinnitus

Brasilien
Vanderbilt University
Eli Lilly and Company

Afsluttet

Medicin, vægtøgning og GI-hormoner

Bipolar depression

Forenede Stater

En langsigtet, åben-label undersøgelse om skizofreni

En langsigtet, open-label, multicenter undersøgelse af LY2140023 sammenlignet med atypisk antipsykotisk behandlingsstandard hos patienter med DSM-IV-TR skizofreni

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Forventet)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Tidsramme

Sekundære resultatmål

Resultatmål

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (FAKTISKE)

Studieafslutning (FAKTISKE)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (SKØN)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (SKØN)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Olanzapin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gabon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer