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

NCT ID: NCT00600756

Last Updated: 2012-10-05

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

798 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Schizophrenic Disorders

Keywords

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schizophrenia SWNK

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Quetiapine XR

Group Type EXPERIMENTAL

Quetiapine XR

Intervention Type DRUG

Oral, once daily, tablets of 400 mg to 800 mg

Risperidone

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

Oral, once daily, tablets of 2 mg to 6 mg

Interventions

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Quetiapine XR

Oral, once daily, tablets of 400 mg to 800 mg

Intervention Type DRUG

Risperidone

Oral, once daily, tablets of 2 mg to 6 mg

Intervention Type DRUG

Other Intervention Names

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Seroquel XR Risperdal

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Brecher, MSD

Role: STUDY_DIRECTOR

AstraZeneca

Prof Naber, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Eppendorf

Locations

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Assebroek, Belgium, Belgium

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Hasselt, Belgium, Belgium

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Liège, Belgium, Belgium

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Montignies-sur-Sambre, Belgium, Belgium

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Roeselare, Belgium, Belgium

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Sint-Denijs-Westrem, , Belgium

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Tournai, , Belgium

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Fortaleza, Ceará, Brazil

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Salvador, Estado de Bahia, Brazil

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Aparecida de Goiânia, Goiás, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Curitiba, Paraná, Brazil

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Recife, Pernambuco, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Itapira, São Paulo, Brazil

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Ribeirão Preto, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Sorocaba, São Paulo, Brazil

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Botucatu, , Brazil

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Cerova Koria Village, Veliko Tarnovo, Bulgaria

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Pazardzhik, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Varna, , Bulgaria

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Barrio Los Yoses, Provincia de San José, Costa Rica

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Curridabat, Provincia de San José, Costa Rica

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Guadalupe, Provincia de San José, Costa Rica

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Helsinki, , Finland

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Kitee, , Finland

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Kuopio, , Finland

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Lapua, , Finland

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Pori, , Finland

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Raahe, , Finland

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Rovaniemi, , Finland

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Tampere, , Finland

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Turku, , Finland

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Bad Saarow, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Bochum, , Germany

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Butzbach, , Germany

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Cologne, , Germany

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Darmstadt, , Germany

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Duisburg, , Germany

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Gelsenkirchen, , Germany

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Grevenbroich, , Germany

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Hamburg, , Germany

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Hattingen, , Germany

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Hildesheim, , Germany

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Königsbrück, , Germany

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Mittweida, , Germany

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München, , Germany

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Oranienburg, , Germany

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Siegen, , Germany

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Stralsund, , Germany

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Wismar, , Germany

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Andria, BA, Italy

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Feltre, BL, Italy

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Maddaloni, CE, Italy

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Sora, FR, Italy

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Genova, GE, Italy

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Milan, MI, Italy

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Perugia, PG, Italy

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Fidenza, PR, Italy

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Parma, PR, Italy

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Palmi, RC, Italy

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Rimini, RN, Italy

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Salerno, SA, Italy

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Sassari, SS, Italy

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Chioggia, VE, Italy

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Ancona, , Italy

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Pompei, , Italy

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México, D.f., Mexico

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México, D.F, Mexico

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Monterrey, Nuevo Leon, Mexico, Mexico

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San Luis Potosí City, San Luis Potosí, Mexico

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Guadalajara Jalisco, , Mexico

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México, , Mexico

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Yucatán, , Mexico

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Abraveses, , Portugal

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Braga, , Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Santarém, , Portugal

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Piteşti, Argeş, Romania

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Galati, Galați County, Romania

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Bucharest, , Romania

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Craiova, , Romania

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Sibiu, , Romania

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Moscow, Russia, Russia

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Kazan', , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Jaén, Andalusia, Spain

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Málaga, Andalusia, Spain

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Seville, Andalusia, Spain

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Zamudio (vizcaya), Basque Country, Spain

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Salamanca, Castille and León, Spain

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Zamora, Castille and León, Spain

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Mataro (barcelona), Catalonia, Spain

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Vigo, Galicia, Spain

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Madrid, Madrid, Spain

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Langreo, Principality of Asturias, Spain

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Elche (alicante), Valencia, Spain

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Sant Joan d'Alacant, Valencia, Spain

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Prilly, Canton of Vaud, Switzerland

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Wil, , Switzerland

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Istanbul, Turkey, Turkey (Türkiye)

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Manisa, Turkey, Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Elâzığ, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Countries

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Denmark Belgium Brazil Bulgaria Costa Rica Finland Germany Italy Mexico Portugal Romania Russia Spain Switzerland Turkey (Türkiye)

References

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Naber D, Peuskens J, Schwarzmann N, Goltz M, Kruger H, Lambert M, Haro JM. Subjective well-being in schizophrenia: a randomised controlled open-label 12-month non-inferiority study comparing quetiapine XR with risperidone (RECOVER). Eur Neuropsychopharmacol. 2013 Oct;23(10):1257-69. doi: 10.1016/j.euroneuro.2013.07.006. Epub 2013 Jul 29.

Reference Type DERIVED
PMID: 23953270 (View on PubMed)

Other Identifiers

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D1443L00039

Identifier Type: -

Identifier Source: org_study_id