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

Schizophrenic Disorders Clinical Trial

— RECOVER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600756
• Other study ID #: D1443L00039
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2008
• Last updated: October 2, 2012
• Start date: January 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentBrazil: Ministry of HealthBulgaria: Ministry of HealthCosta Rica: Ministry of Health Costa RicaDenmark: Ministry of HealthFinland: Ministry of Social Affairs and HealthGermany: Federal Institute for Drugs and Medical DevicesItaly: National Institute of HealthMexico: National Institute of Public Health, Health SecretariatPortugal: National Pharmacy and Medicines InstituteRomania: Ministry of Public HealthRussia: Ministry of Health of the Russian FederationSpain: Ministry of Health and ConsumptionSwitzerland: Federal Office of Public HealthTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 798
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenic Disorders

Intervention

Drug:
• Quetiapine XR
Oral, once daily, tablets of 400 mg to 800 mg
• Risperidone
Oral, once daily, tablets of 2 mg to 6 mg

Locations

Country	Name	City	State
Belgium	Research Site	Assebroek
Belgium	Research Site	Hasselt
Belgium	Research Site	Liege
Belgium	Research Site	Montignies-sur-sambre
Belgium	Research Site	Roeselare
Belgium	Research Site	Sint-denijs-westrem
Belgium	Research Site	Tournai
Brazil	Research Site	Aparecida de Goiania	GO
Brazil	Research Site	Belo Horizonte	Minas Gerais
Brazil	Research Site	Botucatu
Brazil	Research Site	Curitiba	PR
Brazil	Research Site	Fortaleza	CE
Brazil	Research Site	Itapira	SP
Brazil	Research Site	Porto Alegre	RS
Brazil	Research Site	Recife	PE
Brazil	Research Site	Ribeirao Preto	SP
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Salvador	BA
Brazil	Research Site	Sao Paulo	SP
Brazil	Research Site	Sorocaba	SP
Bulgaria	Research Site	Cerova Koria Village	Veliko Tarnovo
Bulgaria	Research Site	Pazardjik
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Stara Zagora
Bulgaria	Research Site	Varna
Costa Rica	Research Site	Barrio Los Yoses	San Jose
Costa Rica	Research Site	Curridabat	San Jose
Costa Rica	Research Site	Guadalupe	San Jose
Finland	Research Site	Helsinki
Finland	Research Site	Kitee
Finland	Research Site	Kuopio
Finland	Research Site	Lapua
Finland	Research Site	Pori
Finland	Research Site	Raahe
Finland	Research Site	Rovaniemi
Finland	Research Site	Tampere
Finland	Research Site	Turku
Germany	Research Site	Bad Saarow
Germany	Research Site	Berlin
Germany	Research Site	Bielefeld
Germany	Research Site	Bochum
Germany	Research Site	Butzbach
Germany	Research Site	Darmstadt
Germany	Research Site	Duisburg
Germany	Research Site	Gelsenkirchen
Germany	Research Site	Grevenbroich
Germany	Research Site	Hamburg
Germany	Research Site	Hattingen
Germany	Research Site	Hildesheim
Germany	Research Site	Koln
Germany	Research Site	Konigsbruck
Germany	Research Site	Mittweida
Germany	Research Site	Munchen
Germany	Research Site	Oranienburg
Germany	Research Site	Siegen
Germany	Research Site	Stralsund
Germany	Research Site	Wismar
Italy	Research Site	Ancona
Italy	Research Site	Andria	BA
Italy	Research Site	Chioggia	VE
Italy	Research Site	Feltre	BL
Italy	Research Site	Fidenza	PR
Italy	Research Site	Genova	GE
Italy	Research Site	Maddaloni	CE
Italy	Research Site	Milano	MI
Italy	Research Site	Palmi	RC
Italy	Research Site	Parma	PR
Italy	Research Site	Perugia	PG
Italy	Research Site	Pompei
Italy	Research Site	Rimini	RN
Italy	Research Site	Salerno	SA
Italy	Research Site	Sassari	SS
Italy	Research Site	Sora	FR
Mexico	Research Site	Guadalajara Jalisco
Mexico	Research Site	Mexico
Mexico	Research Site	Mexico	D.f.
Mexico	Research Site	Mexico	D.F
Mexico	Research Site	Monterrey, Nuevo Leon
Mexico	Research Site	SLP
Mexico	Research Site	Yucatan
Portugal	Research Site	Abraveses
Portugal	Research Site	Braga
Portugal	Research Site	Coimbra
Portugal	Research Site	Lisboa
Portugal	Research Site	Porto
Portugal	Research Site	Santarem
Romania	Research Site	Bucharest
Romania	Research Site	Craiova
Romania	Research Site	Galati
Romania	Research Site	Pitesti	Arges
Romania	Research Site	Sibiu
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow	Russia
Russian Federation	Research Site	St. Petersburg
Spain	Research Site	Elche (alicante)	Comunidad Valenciana
Spain	Research Site	Jaen	Andalucia
Spain	Research Site	Madrid	Comunidad de Madrid
Spain	Research Site	Malaga	Andalucia
Spain	Research Site	Mataro (barcelona)	Cataluna
Spain	Research Site	Salamanca	Castilla Leon
Spain	Research Site	Sama de Langreo	Asturias
Spain	Research Site	San Juan de Alicante	Comunidad Valenciana
Spain	Research Site	Sevilla	Andalucia
Spain	Research Site	Vigo	Galicia
Spain	Research Site	Zamora	Castilla Leon
Spain	Research Site	Zamudio (vizcaya)	Pais Vasco
Switzerland	Research Site	Prilly	Waadt
Switzerland	Research Site	WIL
Turkey	Research Site	Ankara
Turkey	Research Site	Elazig
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	Manisa

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  Brazil,  Bulgaria,  Costa Rica,  Finland,  Germany,  Italy,  Mexico,  Portugal,  Romania,  Russian Federation,  Spain,  Switzerland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population	The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.	Baseline and Month 12	No
Secondary	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	The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being.	Baseline and Month 12	No
Secondary	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.	The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.	Baseline and 12 months	No
Secondary	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.	The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.	Baseline and 12 months	No
Secondary	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.	The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.	Baseline and 12 months	No
Secondary	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.	The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.	Baseline and 12 months	No
Secondary	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.	The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24.	Baseline and 12 months	No
Secondary	The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population	Remission was defined as a SWN-K total score greater than or equal to 80. The reported population is participants who showed remission over, time from baseline to Month 12	12 months	No
Secondary	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).	For the CGI-SCH overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0). Change from baseline in CGI-SCH overall severity of illness in number of participants with CGI-SCH overall severity score improvement.	12 months	No
Secondary	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	For the CGI-SCH (Clinical Global Impression-Schizophrenia severity of illness scale) overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). Change from baseline in CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0).	12 months	No
Secondary	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	The CDSS total score is the sum of 9 questions and ranges from 0 to 27. The higher the score, the more severe are the symptoms.	12 months	No
Secondary	The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population	Relapse is defined as at least one increase of greater than or equal to 2 points on the CGI-SCH overall severity score during the treatment period or at least one hospitalization due to psychiatric disorders during the treatment period.	12 months	No
Secondary	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.	The Euro Quality of Life - 5 dimension index (EQ-5D) is the result of the application of a formula that essentially attaches values (also called weights) to each of the levels (no, some, or heavy problems) in each dimension (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). These weights are issued from a representative sample of the general population. The total possible maximum value was 1 (healthy life) and the minimum value was 0 (death).	12 months	No
Secondary	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	Stable State was defined as having the same status in occupational and residential status as at Baseline.	12 months	No
Secondary	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	Workers and students are defined from the modified vocational status index excluding subjects "Retired" or "Unemployed, whether or not expected to work".	12 months	No
Secondary	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	All hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards, and in day clinics.	12 months	No
Secondary	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	Unscheduled visits due to worsening of schizophrenia, dose change or adverse event including the hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards and in day clinics.	Month 12	No
Secondary	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		12 months	No
Secondary	Number of Participants Using Antidepressants at Month 12 in the ITT Population	The number of participants who were taking at least 1 antidepressant at Month 12. Antidepressants are all concomitant medications classified in the Anatomical Therapeutic Chemical(ATC)Subgroup "N06-Antidepressants".	12 months	No
Secondary	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	Other psychotropic medications include antiepileptics, anti-parkinson drugs, antipsychotics, and antidepressants.	12 months	No
Secondary	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		12 months	No
Secondary	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	Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).	12 months	No
Secondary	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	Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).	12 months	No
Secondary	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	Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).	12 months	No
Secondary	The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Extra-pyramidal Events at Month 12 in the Safety Population	Extra-pyramidal events include tremor, hypokinesia, muscle rigidity, hyperkinesia, and extrapyramidal disorder.	12 months	No
Secondary	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	Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).	12 months	No
Secondary	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	The normal range for men is 0 to 14, and for women is 0 to 24.	12 months	No
Secondary	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	Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). An individual AE is defined as an AE with a worse degree compared with Baseline and with a possible or probable relationship to study drug.	12 months	No
Secondary	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	Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Hyperprolactinaemia in women is defined as number of women who show the individual adverse event (AE) hyperprolactinaemia. An individual AE Hyperprolactinaemia is defined as an AE with a worse degree of hyperprolactinaemia compared with baseline and with a possible or probable relationship to study drug.	Month 12	No
Secondary	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	Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Sexual dysfunction in men is defined as number of men who show the individual adverse event (AE) sexual dysfunction. An individual AE sexual dysfunction is defined as an AE with a worse degree of sexual dysfunction compared with baseline and with a possible or probable relationship to study drug.	Month 12	No