Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone
RECOVER
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
1 other identifier
interventional
798
14 countries
116
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2008
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 9, 2008
CompletedFirst Posted
Study publicly available on registry
January 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
September 12, 2012
CompletedOctober 5, 2012
October 1, 2012
1.8 years
January 9, 2008
October 20, 2010
October 2, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score
The SWN-K is comprised of 20 questions, rated on a 6-point scale from 1 (not at all) to 6 (very much). Scores range from 20 to 120, with higher scores implying higher subjective well-being. A responder is defined as a subject with an increase of 10 points or 20% from baseline in SWN-K total score (non-inferiority limit of -9.7% in responder rate)
6 months
Secondary Outcomes (30)
Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population
Baseline and Month 12
Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Intent-to-Treat (ITT) Population
Baseline and Month 12
Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Physical Functioning at Month 12 in the ITT Population.
Baseline and 12 months
Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Social Integration at Month 12 in the ITT Population.
Baseline and 12 months
Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Mental Functioning at Month 12 in the ITT Population.
Baseline and 12 months
- +25 more secondary outcomes
Study Arms (2)
Quetiapine XR
EXPERIMENTALRisperidone
ACTIVE COMPARATORInterventions
Oral, once daily, tablets of 400 mg to 800 mg
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (116)
Research Site
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)
Related Publications (1)
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.
PMID: 23953270DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Martin Brecher, MSD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Prof Naber, MD
Klinikum Eppendorf
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2008
First Posted
January 25, 2008
Study Start
January 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
October 5, 2012
Results First Posted
September 12, 2012
Record last verified: 2012-10