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Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia

3. januar 2013 opdateret af: AstraZeneca

6-week Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Evaluate the Feasibility of Switching From Immediate-release Quetiapine Fumarate (SEROQUEL) to Sustained-release Quetiapine Fumarate in Outpatients With Schizophrenia (Abbreviated)

The purpose of this study is to determine that the efficacy of the sustained release (SR) formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR) formulation.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Studieoversigt

Status

Afsluttet

Betingelser

Skizofreni

Intervention / Behandling

Medicin: Seroquel SR

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

454

Fase

Fase 3

Kontakter og lokationer

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

Studiesteder

Australien
- - QLD, Australien
    - Research Site
Bulgarien
- - Burgas, Bulgarien
    - Research Site
  - Radnevo, Bulgarien
    - Research Site
  - Varna, Bulgarien
    - Research Site
Canada
- - Quebec, Canada
    - Research Site
- British Columbia
  - Vancouver, British Columbia, Canada
    - Research Site
- Ontario
  - Aurora, Ontario, Canada
    - Research Site
  - Burlington, Ontario, Canada
    - Research Site
  - Mississauga, Ontario, Canada
    - Research Site
  - Orleans, Ontario, Canada
    - Research Site
  - Toronto, Ontario, Canada
    - Research Site
- Quebec
  - Sherbrooke, Quebec, Canada
    - Research Site
- Saskatchewan
  - Prince Albert, Saskatchewan, Canada
    - Research Site
Estland
- - Põltsamaa, Estland
    - Research Site
  - Tallinn, Estland
    - Research Site
  - Tartu, Estland
    - Research Site
Finland
- - Helsinki, Finland
    - Research Site
  - Mikkeli, Finland
    - Research Site
  - Turku, Finland
    - Research Site
Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater
    - Research Site
- California
  - Anaheim, California, Forenede Stater
    - Research Site
  - Cerritos, California, Forenede Stater
    - Research Site
  - Garden Grove, California, Forenede Stater
    - Research Site
  - National City, California, Forenede Stater
    - Research Site
  - Pasadena, California, Forenede Stater
    - Research Site
  - San Diego, California, Forenede Stater
    - Research Site
  - Santa Ana, California, Forenede Stater
    - Research Site
- Florida
  - North Miami, Florida, Forenede Stater
    - Research Site
- Georgia
  - Atlanta, Georgia, Forenede Stater
    - Research Site
- Illinois
  - Hoffman Estates, Illinois, Forenede Stater
    - Research Site
- Louisiana
  - New Orleans, Louisiana, Forenede Stater
    - Research Site
- Mississippi
  - Jackson, Mississippi, Forenede Stater
    - Research Site
- New Jersey
  - Clementon, New Jersey, Forenede Stater
    - Research Site
- New York
  - Staten Island, New York, Forenede Stater
    - Research Site
- Texas
  - Austin, Texas, Forenede Stater
    - Research Site
  - Houston, Texas, Forenede Stater
    - Research Site
- Virginia
  - Richmond, Virginia, Forenede Stater
    - Research Site
Italien
- - Quartu Sant Elena, Italien, CA
    - Research Site
- BO
  - Bologna, BO, Italien
    - Research Site
- CA
  - Cagliari, CA, Italien
    - Research Site
- PG
  - Citta' di Castello, PG, Italien
    - Research Site
  - Ellera di Corciano, PG, Italien
    - Research Site
- TO
  - Torino, TO, Italien
    - Research Site
- VI
  - Bassano Del Grappa, VI, Italien
    - Research Site
Letland
- - Riga, Letland
    - Research Site
  - Sigulda, Letland
    - Research Site
Litauen
- - Klapeda, Litauen
    - Research Site
  - Siauliai, Litauen
    - Research Site
  - Vilnius, Litauen
    - Research Sitte
- Kaunas
  - Ziegzdrai, Kaunas, Litauen
    - Research Site
Spanien
- - Madrid, Spanien
    - Research Site
  - Villamartin, Spanien
    - Research Site
- Cádiz
  - Jerez de la Frontera, Cádiz, Spanien
    - Research Site
- Madrid
  - Alcobendas, Madrid, Spanien
    - Research Site
  - Colmenar Viejo, Madrid, Spanien
    - Research Site
  - Mostoles, Madrid, Spanien
    - Research Site
Tyskland
- - Halle, Tyskland
    - Research Site
  - Marburg, Tyskland
    - Research Site
- Bayern
  - München, Bayern, Tyskland
    - Research Site
- Niedersachsen
  - Göttingen, Niedersachsen, Tyskland
    - Research Site
- Nordrhein-Westfalen
  - Aachen, Nordrhein-Westfalen, Tyskland
    - Research Site
  - Aachen, Nordrhein-Westfalen, Tyskland
    - Research Center
- Thüringen
  - Jena, Thüringen, Tyskland
    - Research Site
Ungarn
- - Budapest, Ungarn
    - Research Site
  - Debrecen, Ungarn
    - Research Site
  - Gyula, Ungarn
    - Research Site
  - Nagykálló, Ungarn
    - Research Site
  - Szeged, Ungarn
    - Research Site
  - Székesfehérvár, Ungarn
    - Research Site

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, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

A stable dose of quetiapine IR between 300 and 800 mg/day within 4 weeks prior to the enrolment visit (Visit 1) as judged by the investigator.
Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.
Able to understand and comply with the requirements of the study, as judged by the investigator.

Exclusion Criteria:

Meeting the criteria for any other (than schizophrenia) Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I diagnosis, concomitant organic mental disorder or mental retardation.
Patients with substance abuse or dependence, as defined by DSM-IV, and not in full remission. A urine drug screen test will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence.
Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids, as judged by the investigator.
Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.

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	Tidsramme
The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more Tidsramme: from randomisation to any visit	from randomisation to any visit

Sekundære resultatmål

Resultatmål	Tidsramme
The change in PANSS total score Tidsramme: from randomization to week 6	from randomization to week 6
The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively Tidsramme: from randomization to week 6	from randomization to week 6
The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4 Tidsramme: at week 6	at week 6

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

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. november 2004

Primær færdiggørelse (Faktiske)

1. februar 2006

Studieafslutning (Faktiske)

1. februar 2006

Datoer for studieregistrering

Først indsendt

13. september 2005

Først indsendt, der opfyldte QC-kriterier