Clinical trial NCT00600756: Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenic Disorders
Keywords: schizophrenia
SWNK
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-01-25
Enrollment: 798
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score
timeFrame: 6 months
Secondary outcomes:
measure: Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population
timeFrame: Baseline and Month 12
measure: 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
timeFrame: Baseline and Month 12
measure: 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.
timeFrame: Baseline and 12 months
measure: 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.
timeFrame: Baseline and 12 months
measure: 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.
timeFrame: Baseline and 12 months
measure: Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Self-control at Month 12 in the ITT Population.
timeFrame: Baseline and 12 months
measure: Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Emotional Regulation at Month 12 in the ITT Population.
timeFrame: Baseline and 12 months
measure: The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population
timeFrame: 12 months
measure: The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score (Improved).
timeFrame: 12 months
measure: The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score
timeFrame: 12 months
measure: The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) Total Score
timeFrame: 12 months
measure: The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population
timeFrame: 12 months
measure: Evaluation of Effect of Quetiapine XR Versus Risperidone on the Health-related Quality of Life of Patients With Schizophrenia by Evaluating the Change From Baseline in EQ-5D(Euro Quality of Life-5 Dimension) Index Score at Month 12 in the ITT Population.
timeFrame: 12 months
measure: To Evaluate the Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population Regarding Health Economics Outcomes by Evaluating the Functional Improvement Rate of the Modified Vocational Status Index/ Location Code Index: Stable State
timeFrame: 12 months
measure: The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Mean Number of Lost School/Work Days at Month 12 in the ITT Population
timeFrame: 12 months
measure: The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Participants With at Least 1 Hospitalization Due to Psychiatric Disorders at Month 12 in the ITT Population
timeFrame: 12 months
measure: Number of Subjects Who Had an Unscheduled Visits Due to Worsening of Schizophrenia, Dose Change, or Adverse Event at Month 12 in the ITT Population
timeFrame: Month 12
measure: The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Time Between First Study Drug Intake and First Hospitalization for Patients With 1 Hospitalization in the ITT Population
timeFrame: 12 months
measure: Number of Participants Using Antidepressants at Month 12 in the ITT Population
timeFrame: 12 months
measure: The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Number of Participants Using Other Psychotropic Medications at Month 12 in the ITT Population
timeFrame: 12 months
measure: The Compliance of Patients Taking Quetiapine XR Versus Risperidone at Month 12 by Evaluating the Number of Participants Who Returned Study Drug at Month 12 in the ITT Population
timeFrame: 12 months
measure: The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants With a Treatment-emergent Adverse Event (TEAEs) at Month 12 in the Safety Population
timeFrame: 12 months
measure: The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Discontinued the Study Because of an TEAE at Month 12 in the Safety Population
timeFrame: 12 months
measure: The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Extra-pyramidal TEAE at Month 12 in the Safety Population
timeFrame: 12 months
measure: The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Extra-pyramidal Events at Month 12 in the Safety Population
timeFrame: 12 months
measure: The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Cardiac TEAE at Month 12 in the Safety Population
timeFrame: 12 months
measure: The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Mean Change From Baseline to Month 12 in Prolactin Levels in the Safety Population
timeFrame: 12 months
measure: The Safety and Tolerability of Quetiapine XR vs Risperidone by Evaluating the Number of Participants at Month 12 in Safety Population With Individual Symptoms Assessed by the Modified Udvalg for Kliniske Undersogelser, Side Effect Rating Scale: Neurologic
timeFrame: 12 months
measure: The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Hyperprolactinaemia in Women
timeFrame: Month 12
measure: The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Sexual Dysfunction in Men
timeFrame: Month 12
Other outcomes:
Locations:
city: Assebroek
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Montignies-sur-sambre
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Sint-denijs-westrem
country: Belgium
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city: Tournai
country: Belgium
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city: Salvador
country: Brazil
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state: BA
city: Fortaleza
country: Brazil
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state: CE
city: Aparecida de Goiania
country: Brazil
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state: GO
city: Belo Horizonte
country: Brazil
facility: Research Site
state: Minas Gerais
city: Recife
country: Brazil
facility: Research Site
state: PE
city: Curitiba
country: Brazil
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state: PR
city: Porto Alegre
country: Brazil
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state: RS
city: Itapira
country: Brazil
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state: SP
city: Ribeirao Preto
country: Brazil
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state: SP
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Sorocaba
country: Brazil
facility: Research Site
state: SP
city: Botucatu
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Cerova Koria Village
country: Bulgaria
facility: Research Site
state: Veliko Tarnovo
city: Pazardjik
country: Bulgaria
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city: Pleven
country: Bulgaria
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city: Plovdiv
country: Bulgaria
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city: Sofia
country: Bulgaria
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city: Stara Zagora
country: Bulgaria
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city: Varna
country: Bulgaria
facility: Research Site
city: Barrio Los Yoses
country: Costa Rica
facility: Research Site
state: San Jose
city: Curridabat
country: Costa Rica
facility: Research Site
state: San Jose
city: Guadalupe
country: Costa Rica
facility: Research Site
state: San Jose
city: Helsinki
country: Finland
facility: Research Site
city: Kitee
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Lapua
country: Finland
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city: Pori
country: Finland
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city: Raahe
country: Finland
facility: Research Site
city: Rovaniemi
country: Finland
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city: Tampere
country: Finland
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city: Turku
country: Finland
facility: Research Site
city: Bad Saarow
country: Germany
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city: Berlin
country: Germany
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city: Bielefeld
country: Germany
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city: Bochum
country: Germany
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city: Butzbach
country: Germany
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city: Darmstadt
country: Germany
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city: Duisburg
country: Germany
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city: Gelsenkirchen
country: Germany
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city: Grevenbroich
country: Germany
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city: Hamburg
country: Germany
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city: Hattingen
country: Germany
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city: Hildesheim
country: Germany
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city: Koln
country: Germany
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city: Konigsbruck
country: Germany
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city: Mittweida
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Oranienburg
country: Germany
facility: Research Site
city: Siegen
country: Germany
facility: Research Site
city: Stralsund
country: Germany
facility: Research Site
city: Wismar
country: Germany
facility: Research Site
city: Andria
country: Italy
facility: Research Site
state: BA
city: Feltre
country: Italy
facility: Research Site
state: BL
city: Maddaloni
country: Italy
facility: Research Site
state: CE
city: Sora
country: Italy
facility: Research Site
state: FR
city: Genova
country: Italy
facility: Research Site
state: GE
city: Milano
country: Italy
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state: MI
city: Perugia
country: Italy
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state: PG
city: Fidenza
country: Italy
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state: PR
city: Parma
country: Italy
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state: PR
city: Palmi
country: Italy
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state: RC
city: Rimini
country: Italy
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state: RN
city: Salerno
country: Italy
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state: SA
city: Sassari
country: Italy
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state: SS
city: Chioggia
country: Italy
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state: VE
city: Ancona
country: Italy
facility: Research Site
city: Pompei
country: Italy
facility: Research Site
city: Mexico
country: Mexico
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state: D.f.
city: Mexico
country: Mexico
facility: Research Site
state: D.F
city: Guadalajara Jalisco
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Monterrey, Nuevo Leon
country: Mexico
facility: Research Site
city: SLP
country: Mexico
facility: Research Site
city: Yucatan
country: Mexico
facility: Research Site
city: Abraveses
country: Portugal
facility: Research Site
city: Braga
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Santarem
country: Portugal
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
state: Arges
city: Bucharest
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Galati
country: Romania
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
state: Russia
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Jaen
country: Spain
facility: Research Site
state: Andalucia
city: Malaga
country: Spain
facility: Research Site
state: Andalucia
city: Sevilla
country: Spain
facility: Research Site
state: Andalucia
city: Sama de Langreo
country: Spain
facility: Research Site
state: Asturias
city: Salamanca
country: Spain
facility: Research Site
state: Castilla Leon
city: Zamora
country: Spain
facility: Research Site
state: Castilla Leon
city: Mataro (barcelona)
country: Spain
facility: Research Site
state: Cataluna
city: Madrid
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: Elche (alicante)
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: San Juan de Alicante
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Vigo
country: Spain
facility: Research Site
state: Galicia
city: Zamudio (vizcaya)
country: Spain
facility: Research Site
state: Pais Vasco
city: Prilly
country: Switzerland
facility: Research Site
state: Waadt
city: WIL
country: Switzerland
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Elazig
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Manisa
country: Turkey
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Martin Brecher, MSD
role: STUDY_DIRECTOR
affiliation: Klinikum Eppendorf
name: Prof Naber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.