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Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.

18. desember 2007 oppdatert av: Wyeth is now a wholly owned subsidiary of Pfizer

A Multicenter, Randomized, Double-Blind, Parallel-Group Fixed-Dose Study of the Effect on Weight of Befeprunox Versus Olanzapine in the Treatment of Outpatients With Schizophrenia.

This study will compare bifeprunox to a currently marketed medication, Zyprexa (olanzapine), with respect to the affect on weight during the treatment of outpatients with schizophrenia. The study will compare the effect of these medications on several variables, including body weight and triglyceride levels.

Studieoversikt

Status

Fullført

Forhold

Schizofreni

Intervensjon / Behandling

Legemiddel: bifeprunox, olanzapine

Detaljert beskrivelse

This is a multicenter, randomized, double-blind, parallel-group study of bifeprunox in the treatment of outpatients with schizophrenia, with olanzapine as the active comparator. Subjects must be stable for 3 months or more of treatment with olanzapine at baseline. There will be 2 treatment arms in this study, approximately 60 subjects per arm. After randomization and blinding, each subject will either remain on olanzapine or switch to bifeprunox. Assessments, including body weight and waist measurements, will be made at each study visit.Subjects will participate in the study for approximately 11 weeks. After a screening period of 6 to 14 days, eligible subjects will be treated for 8 weeks. Subjects who do not enter the long-term extension will return for a follow-up visit 7 days after discontinuing the use of test article. Subjects who do enter the long-term extension will have a 7-day taper/titration period after the 8 weeks of double-blind treatment.

Studietype

Intervensjonell

Registrering (Forventet)

120

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Arkansas
  - Little Rock, Arkansas, Forente stater, 72201
  - Little Rock, Arkansas, Forente stater, 72211
- California
  - Anaheim, California, Forente stater, 92802
  - Anaheim, California, Forente stater, 92804
  - Anaheim, California, Forente stater, 92805
  - Boynton Beach, California, Forente stater, 33426
  - Costa Mesa, California, Forente stater, 92363
  - Costa Mesa, California, Forente stater, 92627
  - Escondido, California, Forente stater, 92025
  - Garden Grove, California, Forente stater, 92845
  - Glendale, California, Forente stater, 91206
  - Huntington Beach, California, Forente stater, 92648
  - La Mesa, California, Forente stater, 91942
  - National City, California, Forente stater, 91950
  - Oceanside, California, Forente stater, 92056
  - Paramount, California, Forente stater, 90723
  - Rosemead, California, Forente stater, 91770
  - San Diego, California, Forente stater, 92108
  - San Diego, California, Forente stater, 92123
  - San Diego, California, Forente stater, 92126
  - Santa Ana, California, Forente stater, 92705
- Connecticut
  - New Britain, Connecticut, Forente stater, 06050
  - New London, Connecticut, Forente stater, 06320
- Florida
  - Deland, Florida, Forente stater, 32720
  - Ft. Lauderdale, Florida, Forente stater, 33319
  - Jacksonville, Florida, Forente stater, 32256
  - North Miami, Florida, Forente stater, 33161
  - St. Petersburg, Florida, Forente stater, 33711
- Georgia
  - Atlanta, Georgia, Forente stater, 30308
  - Augusta, Georgia, Forente stater, 30912
  - Marietta, Georgia, Forente stater, 30060
- Idaho
  - Coevr d'Alene, Idaho, Forente stater, 83814
- Illinois
  - Chicago, Illinois, Forente stater, 60631
  - Hoffman Estates, Illinois, Forente stater, 60194
  - Joliet, Illinois, Forente stater, 60077
  - Naperville, Illinois, Forente stater, 60540
- Louisiana
  - Lake Charles, Louisiana, Forente stater, 70601
- Maryland
  - Gaithersburg, Maryland, Forente stater, 20877
- Massachusetts
  - Worcester, Massachusetts, Forente stater, 01605
- Mississippi
  - Flowood, Mississippi, Forente stater, 39232
- Missouri
  - St. Louis, Missouri, Forente stater, 63110
  - St. Louis, Missouri, Forente stater, 63118
  - St. Louis, Missouri, Forente stater, 63128
- Nebraska
  - North Platte, Nebraska, Forente stater, 69101
- New Jersey
  - Cherry Hill, New Jersey, Forente stater, 08002
  - Clementon, New Jersey, Forente stater, 08021
- New York
  - New York, New York, Forente stater, 10035
  - Rochester, New York, Forente stater, 14624
  - Staten Island, New York, Forente stater, 10312
- North Carolina
  - Butner, North Carolina, Forente stater, 27509
  - Chapel Hill, North Carolina, Forente stater, 27599
  - Durham, North Carolina, Forente stater, 27707
  - Morehead City, North Carolina, Forente stater, 28557
- North Dakota
  - Fargo, North Dakota, Forente stater, 58102
- Ohio
  - Cleveland, Ohio, Forente stater, 44109
- Oklahoma
  - Oklahoma City, Oklahoma, Forente stater, 73139
  - Oklahoma City, Oklahoma, Forente stater, 73118
- Pennsylvania
  - Norristown, Pennsylvania, Forente stater, 19401
  - Philadelphia, Pennsylvania, Forente stater, 19149
  - Pittsburgh, Pennsylvania, Forente stater, 15108
- Tennessee
  - Cordova, Tennessee, Forente stater, 38018
  - Memphis, Tennessee, Forente stater, 38105
  - Murfressboro, Tennessee, Forente stater, 37129
  - Nashville, Tennessee, Forente stater, 37212
- Texas
  - Austin, Texas, Forente stater, 78756
  - DeSoto, Texas, Forente stater, 75115
  - Irving, Texas, Forente stater, 75062

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion criteria:

Current treatment of at least 3 months with olanzapine.
Primary diagnosis of schizophrenia.
Total Positive and Negative Symptoms Scale (PANSS) score <=70 at screening and baseline.

Exclusion criteria:

Psychiatric diagnosis other than schizophrenia, as assessed by the modified Mini International Neuropsychiatric Interview (MINI), and considered by the investigator to be the primary psychiatric diagnosis.
History or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study.
History of any suicide attempt within 3 years of day -1 or significant immediate risk of violence or suicidality.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Dobbelt

Hva måler studien?

Primære resultatmål

Resultatmål
Change from baseline on body weight at the final evaluation.

Sekundære resultatmål

Resultatmål
Change from baseline in triglyceride level; Change from baseline in waist circumference; and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2006

Studiet fullført (Faktiske)

1. september 2007

Datoer for studieregistrering

Først innsendt

21. september 2006

Først innsendt som oppfylte QC-kriteriene