Comparison of the Subjective Well-Being and Tolerability of Quetiapine XR to Risperidone

Condition(s) targeted: Schizophrenic Disorders

Intervention: Quetiapine XR (Drug); Risperidone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Martin Brecher, MSD, Study Director, Affiliation: AstraZeneca
Prof Naber, MD, Principal Investigator, Affiliation: Klinikum Eppendorf

Overall contact:
AstraZeneca Wedel Clinical Study, Information, Phone: 04103-7080

The trial is designed to assess the long term subjective well-being in schizophrenic outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible dose in a naturalistic setting over a period of one year. Secondary outcome measures have been selected for helping in the differentiation of the compared atypical antipsychotics. The primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 6 in terms of responder rate using the self-report instrument SWN-K

Official title: A One-Year Randomized, Prospective, Parallel, Open Comparison of Subjective Well-Being in Schizophrenic Out-Patients Treated With Quetiapine XR (SEROQUEL XR™) or Oral Risperidone at Flexible Dose in a Naturalistic Setting

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: The primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 6 in terms of responder rate using the self-report instrument SWN-K.

Secondary outcome: Among other things a secondary objective of particular interest is to demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 12 by evaluating the change from baseline in SWN-K mean total score.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Treated for symptomatic schizophrenia (DSM-IV-TR codes: 295. 10, 295. 20, 295. 30,295. 60,

295. 90) or schizoaffective disorder (DSM-IV-TR code: 295. 70) or schizophreniform disorder (DSM-IV-TR code: 295. 40). Patients with co-morbid depressive symptoms may be enrolled

- Patient with first episode of the above mentioned disease (item 3) or patient

requiring a medication change for clinical reasons (effectiveness, tolerability, compliance, patient preference), i. e. switch from typical to atypical neuroleptics, switch from other atypical neuroleptics, excluding patients treated with risperidone or quetiapine at the time of enrolment.

Exclusion Criteria:

- Patients with a baseline SWN-K total score of >75

- Patients with previous treatment with risperidone or quetiapine may be enrolled if

change of treatment has not been dictated by major lack of tolerability and efficacy and if date of last dose has been at least 3 months prior to enrolment.

AstraZeneca Wedel Clinical Study, Information, Phone: 04103-7080

Research Site, ANTWERPEN, Belgium; Recruiting

Research Site, ASSEBROEK, Belgium; Recruiting

Research Site, HASSELT, Belgium; Recruiting

Research Site, KORTENBERG, Belgium; Recruiting

Research Site, LEDE, Belgium; Recruiting

Research Site, LIEGE, Belgium; Recruiting

Research Site, MONTIGNIES-SUR-SAMBRE, Belgium; Recruiting

Research Site, ROESELARE, Belgium; Recruiting

Research Site, SINT-DENIJS-WESTREM, Belgium; Recruiting

Research Site, TOURNAI, Belgium; Recruiting

Research Site, RIBEIRAO PRETO, Brazil; Not yet recruiting

Research Site, RIO DE JANEIRO, Brazil; Not yet recruiting

Research Site, PAZARDJIK, Bulgaria; Not yet recruiting

Research Site, PLEVEN, Bulgaria; Not yet recruiting

Research Site, PLOVDIV, Bulgaria; Not yet recruiting

Research Site, SOFIA, Bulgaria; Not yet recruiting

Research Site, STARA ZAGORA, Bulgaria; Not yet recruiting

Research Site, VARNA, Bulgaria; Not yet recruiting

Research Site, FREDERIKSBERG, Denmark; Not yet recruiting

Research Site, GENTOFTE, Denmark; Not yet recruiting

Research Site, GLOSTRUP, Denmark; Not yet recruiting

Research Site, HILLEROD, Denmark; Not yet recruiting

Research Site, ISHOJ, Denmark; Not yet recruiting

Research Site, MIDDELFART, Denmark; Not yet recruiting

Research Site, SKANDERBORG, Denmark; Not yet recruiting

Research Site, HELSINKI, Finland; Not yet recruiting

Research Site, IMATRA, Finland; Not yet recruiting

Research Site, KITEE, Finland; Recruiting

Research Site, KUOPIO, Finland; Recruiting

Research Site, ROVANIEMI, Finland; Not yet recruiting

Research Site, TAMPERE, Finland; Not yet recruiting

Research Site, TURKU, Finland; Recruiting

Research Site, ACHIM, Germany; Not yet recruiting

Research Site, AHRWEILER, Germany; Not yet recruiting

Research Site, BAD SAAROW, Germany; Not yet recruiting

Research Site, BERLIN, Germany; Not yet recruiting

Research Site, BOCHUM, Germany; Not yet recruiting

Research Site, BUTZBACH, Germany; Not yet recruiting

Research Site, DARMSTADT, Germany; Not yet recruiting

Research Site, DUISBURG, Germany; Not yet recruiting

Research Site, ELLWANGEN, Germany; Not yet recruiting

Research Site, ESSEN, Germany; Not yet recruiting

Research Site, GELSENKIRCHEN, Germany; Not yet recruiting

Research Site, GUSTROW, Germany; Not yet recruiting

Research Site, HALLE, Germany; Not yet recruiting

Research Site, HAMBURG, Germany; Recruiting

Research Site, HILDESHEIM, Germany; Not yet recruiting

Research Site, KOLN, Germany; Not yet recruiting

Research Site, KONIGSBRUCK, Germany; Not yet recruiting

Research Site, LEIPZIG, Germany; Not yet recruiting

Research Site, MITTWEIDA, Germany; Not yet recruiting

Research Site, MUNCHEN, Germany; Not yet recruiting

Research Site, ORANIENBURG, Germany; Not yet recruiting

Research Site, ROSTOCK, Germany; Not yet recruiting

Research Site, SIEGEN, Germany; Recruiting

Research Site, STRALSUND, Germany; Not yet recruiting

Research Site, WISMAR, Germany; Not yet recruiting

Research Site, CASERTA, Italy; Not yet recruiting

Research Site, FERRARA, Italy; Not yet recruiting

Research Site, POMPEI, Italy; Not yet recruiting

Research Site, GUADALAJARA JALISCO, Mexico; Not yet recruiting

Research Site, MEXICO, Mexico; Not yet recruiting

Research Site, MONTERREY, NUEVO LEON, Mexico; Not yet recruiting

Research Site, YUCATAN, Mexico; Not yet recruiting

Research Site, SLP, Mexico; Not yet recruiting

Research Site, ABRAVESES, Portugal; Not yet recruiting

Research Site, BRAGA, Portugal; Not yet recruiting

Research Site, COIMBRA, Portugal; Not yet recruiting

Research Site, LISBOA, Portugal; Not yet recruiting

Research Site, PORTO, Portugal; Not yet recruiting

Research Site, SANTAREM, Portugal; Not yet recruiting

Research Site, BUCHAREST, Romania; Not yet recruiting

Research Site, CLUJ-NAPOCA, Romania; Not yet recruiting

Research Site, CRAIOVA, Romania; Not yet recruiting

Research Site, GALATI, Romania; Not yet recruiting

Research Site, MOSCOW, Russian Federation; Not yet recruiting

Research Site, ST. PETERSBURG, Russian Federation; Not yet recruiting

Research Site, GENEVE, Switzerland; Not yet recruiting

Research Site, OETWIL AM SEE, Switzerland; Not yet recruiting

Research Site, WIL, Switzerland; Not yet recruiting

Research Site, ANKARA, Turkey; Not yet recruiting

Research Site, ELAZIG, Turkey; Not yet recruiting

Research Site, ISTANBUL, Turkey; Not yet recruiting

Research Site, IZMIR, Turkey; Not yet recruiting

Research Site, MANISA, Turkey; Not yet recruiting

Research Site, JAEN, ANDALUCIA, Spain; Not yet recruiting

Research Site, MALAGA, ANDALUCIA, Spain; Not yet recruiting

Research Site, SEVILLA, ANDALUCIA, Spain; Recruiting

Research Site, GRANADA, ANDALUC�a, Spain; Not yet recruiting

Research Site, PITESTI, ARGES, Romania; Recruiting

Research Site, SAMA DE LANGREO, ASTURIAS, Spain; Not yet recruiting

Research Site, SALVADOR, BA, Brazil; Not yet recruiting

Research Site, FELTRE, BL, Italy; Not yet recruiting

Research Site, BARCELONA, CATALUNA, Spain; Not yet recruiting

Research Site, MATARO (BARCELONA), CATALUNA, Spain; Not yet recruiting

Research Site, TERRASSA (BARCELONA), CATALUNA, Spain; Not yet recruiting

Research Site, FORTALEZA, CE, Brazil; Not yet recruiting

Research Site, SALAMANCA, Castilla Leon, Spain; Not yet recruiting

Research Site, ZAMORA, Castilla Leon, Spain; Not yet recruiting

Research Site, ARGANDA DEL REY (MADRID), Comunidad De Madrid, Spain; Not yet recruiting

Research Site, MADRID, Comunidad De Madrid, Spain; Not yet recruiting

Research Site, TORREJON DE ARDOZ, Comunidad De Madrid, Spain; Not yet recruiting

Research Site, ELCHE(ALICANTE), Comunidad Valenciana, Spain; Not yet recruiting

Research Site, SAN JUAN DE ALICANTE, Comunidad Valenciana, Spain; Not yet recruiting

Research Site, SORA, FR, Italy; Not yet recruiting

Research Site, VIGO, GALICIA, Spain; Not yet recruiting

Research Site, GENOVA, GE, Italy; Recruiting

Research Site, MILANO, MI, Italy; Not yet recruiting

Research Site, BELO HORIZONTE, Minas Gerais, Brazil; Not yet recruiting

Research Site, ZAMUDIO (VIZCAYA), PAIS VASCO, Spain; Not yet recruiting

Research Site, RECIFE, PE, Brazil; Not yet recruiting

Research Site, CURITIBA, PR, Brazil; Not yet recruiting

Research Site, PALMI, RC, Italy; Not yet recruiting

Research Site, RIMINI, RN, Italy; Not yet recruiting

Research Site, PORTO ALEGRE, RS, Brazil; Not yet recruiting

Research Site, KAZAN, RUSSIA, Russian Federation; Not yet recruiting

Research Site, MOSCOW, RUSSIA, Russian Federation; Not yet recruiting

Research Site, SALERNO, SA, Italy; Not yet recruiting

Research Site, BOTUCATU, SP, Brazil; Not yet recruiting

Research Site, ITAPIRA, SP, Brazil; Not yet recruiting

Research Site, SAO PAULO, SP, Brazil; Not yet recruiting

Research Site, SASSARI, SS, Italy; Not yet recruiting

Research Site, SOTTOMARINA, VE, Italy; Not yet recruiting

Research Site, CEROVA KORIA VILLAGE, Veliko Tarnovo, Bulgaria; Not yet recruiting

Research Site, PRILLY, WAADT, Switzerland; Not yet recruiting

Research Site, ORISTANO, or, Italy; Not yet recruiting

Starting date: January 2008
Ending date: January 2010
Last updated: April 7, 2008