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

Primary Purpose

Schizophrenic Disorders

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Quetiapine XR
Risperidone
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenic Disorders focused on measuring schizophrenia, SWNK

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Quetiapine XR

Risperidone

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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
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.
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).
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.
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.
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).
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.
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".
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.
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.
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
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".
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.
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
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).
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).
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).
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.
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).
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.
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.
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.
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.

Full Information

First Posted
January 9, 2008
Last Updated
October 2, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00600756
Brief Title
Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenic Disorders
Keywords
schizophrenia, SWNK

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
798 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quetiapine XR
Arm Type
Experimental
Arm Title
Risperidone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Quetiapine XR
Other Intervention Name(s)
Seroquel XR
Intervention Description
Oral, once daily, tablets of 400 mg to 800 mg
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
Oral, once daily, tablets of 2 mg to 6 mg
Primary Outcome Measure Information:
Title
Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population
Description
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.
Time Frame
Baseline and Month 12
Title
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
Description
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.
Time Frame
Baseline and Month 12
Title
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.
Description
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.
Time Frame
Baseline and 12 months
Title
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.
Description
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.
Time Frame
Baseline and 12 months
Title
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.
Description
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.
Time Frame
Baseline and 12 months
Title
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.
Description
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.
Time Frame
Baseline and 12 months
Title
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.
Description
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.
Time Frame
Baseline and 12 months
Title
The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population
Description
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
Time Frame
12 months
Title
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).
Description
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.
Time Frame
12 months
Title
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
Description
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).
Time Frame
12 months
Title
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
Description
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.
Time Frame
12 months
Title
The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population
Description
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.
Time Frame
12 months
Title
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.
Description
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).
Time Frame
12 months
Title
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
Description
Stable State was defined as having the same status in occupational and residential status as at Baseline.
Time Frame
12 months
Title
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
Description
Workers and students are defined from the modified vocational status index excluding subjects "Retired" or "Unemployed, whether or not expected to work".
Time Frame
12 months
Title
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
Description
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.
Time Frame
12 months
Title
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
Description
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.
Time Frame
Month 12
Title
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
Time Frame
12 months
Title
Number of Participants Using Antidepressants at Month 12 in the ITT Population
Description
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".
Time Frame
12 months
Title
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
Description
Other psychotropic medications include antiepileptics, anti-parkinson drugs, antipsychotics, and antidepressants.
Time Frame
12 months
Title
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
Time Frame
12 months
Title
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
Description
Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).
Time Frame
12 months
Title
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
Description
Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).
Time Frame
12 months
Title
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
Description
Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).
Time Frame
12 months
Title
The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Extra-pyramidal Events at Month 12 in the Safety Population
Description
Extra-pyramidal events include tremor, hypokinesia, muscle rigidity, hyperkinesia, and extrapyramidal disorder.
Time Frame
12 months
Title
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
Description
Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).
Time Frame
12 months
Title
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
Description
The normal range for men is 0 to 14, and for women is 0 to 24.
Time Frame
12 months
Title
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
Description
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.
Time Frame
12 months
Title
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
Description
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.
Time Frame
Month 12
Title
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
Description
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.
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Brecher, MSD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Prof Naber, MD
Organizational Affiliation
Klinikum Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Assebroek
Country
Belgium
Facility Name
Research Site
City
Hasselt
Country
Belgium
Facility Name
Research Site
City
Liege
Country
Belgium
Facility Name
Research Site
City
Montignies-sur-sambre
Country
Belgium
Facility Name
Research Site
City
Roeselare
Country
Belgium
Facility Name
Research Site
City
Sint-denijs-westrem
Country
Belgium
Facility Name
Research Site
City
Tournai
Country
Belgium
Facility Name
Research Site
City
Salvador
State/Province
BA
Country
Brazil
Facility Name
Research Site
City
Fortaleza
State/Province
CE
Country
Brazil
Facility Name
Research Site
City
Aparecida de Goiania
State/Province
GO
Country
Brazil
Facility Name
Research Site
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Research Site
City
Recife
State/Province
PE
Country
Brazil
Facility Name
Research Site
City
Curitiba
State/Province
PR
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Research Site
City
Itapira
State/Province
SP
Country
Brazil
Facility Name
Research Site
City
Ribeirao Preto
State/Province
SP
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
State/Province
SP
Country
Brazil
Facility Name
Research Site
City
Sorocaba
State/Province
SP
Country
Brazil
Facility Name
Research Site
City
Botucatu
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
Country
Brazil
Facility Name
Research Site
City
Cerova Koria Village
State/Province
Veliko Tarnovo
Country
Bulgaria
Facility Name
Research Site
City
Pazardjik
Country
Bulgaria
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Stara Zagora
Country
Bulgaria
Facility Name
Research Site
City
Varna
Country
Bulgaria
Facility Name
Research Site
City
Barrio Los Yoses
State/Province
San Jose
Country
Costa Rica
Facility Name
Research Site
City
Curridabat
State/Province
San Jose
Country
Costa Rica
Facility Name
Research Site
City
Guadalupe
State/Province
San Jose
Country
Costa Rica
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Kitee
Country
Finland
Facility Name
Research Site
City
Kuopio
Country
Finland
Facility Name
Research Site
City
Lapua
Country
Finland
Facility Name
Research Site
City
Pori
Country
Finland
Facility Name
Research Site
City
Raahe
Country
Finland
Facility Name
Research Site
City
Rovaniemi
Country
Finland
Facility Name
Research Site
City
Tampere
Country
Finland
Facility Name
Research Site
City
Turku
Country
Finland
Facility Name
Research Site
City
Bad Saarow
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Bielefeld
Country
Germany
Facility Name
Research Site
City
Bochum
Country
Germany
Facility Name
Research Site
City
Butzbach
Country
Germany
Facility Name
Research Site
City
Darmstadt
Country
Germany
Facility Name
Research Site
City
Duisburg
Country
Germany
Facility Name
Research Site
City
Gelsenkirchen
Country
Germany
Facility Name
Research Site
City
Grevenbroich
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Hattingen
Country
Germany
Facility Name
Research Site
City
Hildesheim
Country
Germany
Facility Name
Research Site
City
Koln
Country
Germany
Facility Name
Research Site
City
Konigsbruck
Country
Germany
Facility Name
Research Site
City
Mittweida
Country
Germany
Facility Name
Research Site
City
Munchen
Country
Germany
Facility Name
Research Site
City
Oranienburg
Country
Germany
Facility Name
Research Site
City
Siegen
Country
Germany
Facility Name
Research Site
City
Stralsund
Country
Germany
Facility Name
Research Site
City
Wismar
Country
Germany
Facility Name
Research Site
City
Andria
State/Province
BA
Country
Italy
Facility Name
Research Site
City
Feltre
State/Province
BL
Country
Italy
Facility Name
Research Site
City
Maddaloni
State/Province
CE
Country
Italy
Facility Name
Research Site
City
Sora
State/Province
FR
Country
Italy
Facility Name
Research Site
City
Genova
State/Province
GE
Country
Italy
Facility Name
Research Site
City
Milano
State/Province
MI
Country
Italy
Facility Name
Research Site
City
Perugia
State/Province
PG
Country
Italy
Facility Name
Research Site
City
Fidenza
State/Province
PR
Country
Italy
Facility Name
Research Site
City
Parma
State/Province
PR
Country
Italy
Facility Name
Research Site
City
Palmi
State/Province
RC
Country
Italy
Facility Name
Research Site
City
Rimini
State/Province
RN
Country
Italy
Facility Name
Research Site
City
Salerno
State/Province
SA
Country
Italy
Facility Name
Research Site
City
Sassari
State/Province
SS
Country
Italy
Facility Name
Research Site
City
Chioggia
State/Province
VE
Country
Italy
Facility Name
Research Site
City
Ancona
Country
Italy
Facility Name
Research Site
City
Pompei
Country
Italy
Facility Name
Research Site
City
Mexico
State/Province
D.f.
Country
Mexico
Facility Name
Research Site
City
Mexico
State/Province
D.F
Country
Mexico
Facility Name
Research Site
City
Guadalajara Jalisco
Country
Mexico
Facility Name
Research Site
City
Mexico
Country
Mexico
Facility Name
Research Site
City
Monterrey, Nuevo Leon
Country
Mexico
Facility Name
Research Site
City
SLP
Country
Mexico
Facility Name
Research Site
City
Yucatan
Country
Mexico
Facility Name
Research Site
City
Abraveses
Country
Portugal
Facility Name
Research Site
City
Braga
Country
Portugal
Facility Name
Research Site
City
Coimbra
Country
Portugal
Facility Name
Research Site
City
Lisboa
Country
Portugal
Facility Name
Research Site
City
Porto
Country
Portugal
Facility Name
Research Site
City
Santarem
Country
Portugal
Facility Name
Research Site
City
Pitesti
State/Province
Arges
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Craiova
Country
Romania
Facility Name
Research Site
City
Galati
Country
Romania
Facility Name
Research Site
City
Sibiu
Country
Romania
Facility Name
Research Site
City
Moscow
State/Province
Russia
Country
Russian Federation
Facility Name
Research Site
City
Kazan
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Jaen
State/Province
Andalucia
Country
Spain
Facility Name
Research Site
City
Malaga
State/Province
Andalucia
Country
Spain
Facility Name
Research Site
City
Sevilla
State/Province
Andalucia
Country
Spain
Facility Name
Research Site
City
Sama de Langreo
State/Province
Asturias
Country
Spain
Facility Name
Research Site
City
Salamanca
State/Province
Castilla Leon
Country
Spain
Facility Name
Research Site
City
Zamora
State/Province
Castilla Leon
Country
Spain
Facility Name
Research Site
City
Mataro (barcelona)
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Madrid
State/Province
Comunidad de Madrid
Country
Spain
Facility Name
Research Site
City
Elche (alicante)
State/Province
Comunidad Valenciana
Country
Spain
Facility Name
Research Site
City
San Juan de Alicante
State/Province
Comunidad Valenciana
Country
Spain
Facility Name
Research Site
City
Vigo
State/Province
Galicia
Country
Spain
Facility Name
Research Site
City
Zamudio (vizcaya)
State/Province
Pais Vasco
Country
Spain
Facility Name
Research Site
City
Prilly
State/Province
Waadt
Country
Switzerland
Facility Name
Research Site
City
WIL
Country
Switzerland
Facility Name
Research Site
City
Ankara
Country
Turkey
Facility Name
Research Site
City
Elazig
Country
Turkey
Facility Name
Research Site
City
Istanbul
Country
Turkey
Facility Name
Research Site
City
Izmir
Country
Turkey
Facility Name
Research Site
City
Manisa
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
23953270
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.
Results Reference
derived

Learn more about this trial

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

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