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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00600756
First received: January 9, 2008
Last updated: October 2, 2012
Last verified: October 2012
Results First Received: October 20, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenic Disorders
Interventions: Drug: Quetiapine XR
Drug: Risperidone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

This study was a 1-year, randomized, prospective, parallel, open-label study. The study was conducted in 114 study centers in 13 countries.

OR International multi-center study, 180 sites recruited between January 2008 and October 2009.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Screening for eligibility. Patients with a SWN-K total score ≤ 75 were entered into the study.

All patients with “no intake of IP and missing SWN-K total score at baseline or following baseline were included in the study “Overall Number of Participants” but these patients are excluded from the ITT Analysis set!


Reporting Groups
  Description
Quetiapine XR Experimental - oral, once daily, tablets of 400 mg to 800 mg
Risperidone Active Comparator – oral, once daily, tablets of 2 mg to 6 mg

Participant Flow for 2 periods

Period 1:   Analysis After 6 Months
    Quetiapine XR     Risperidone  
STARTED     395     403  
COMPLETED     264 [1]   283 [1]
NOT COMPLETED     131     120  
Adverse Event                 43                 33  
Withdrawal by Subject                 38                 30  
Incorrect Enrollment                 12                 21  
worsening symptom, lack of efficacy                 11                 14  
Severe non-compliance to protocol                 11                 11  
Lost to Follow-up                 10                 8  
Study-specific discontinuation criteria                 6                 3  
[1] Completers are all patients who completed the study up to Visit 5 (including premature withdraw)

Period 2:   Overall Study Analysis After 12 Months
    Quetiapine XR     Risperidone  
STARTED     395     403  
Randomized Analysis     395     403  
Safety Analysis     391     402  
ITT Analysis     379     392  
COMPLETED     212 [1]   227 [1]
NOT COMPLETED     183     176  
Adverse Event                 53                 44  
Withdrawal by Subject                 51                 41  
Incorrect enrollment                 21                 29  
worsening symptom, lack of efficacy                 17                 20  
Severe non-compliance to protocol                 16                 20  
Lost to Follow-up                 16                 13  
Study-specific discontinuation criteria                 9                 9  
[1] Completed study to Visit 7 (includes premature withdrawals with final visit in the Visit 7 window)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Quetiapine XR Experimental - oral, once daily, tablets of 400 mg to 800 mg
Risperidone Active Comparator – oral, once daily, tablets of 2 mg to 6 mg
Total Total of all reporting groups

Baseline Measures
    Quetiapine XR     Risperidone     Total  
Number of Participants  
[units: participants]
  395     403     798  
Age  
[units: Years]
Mean ± Standard Deviation
  39.3  ± 11.7     40.0  ± 11.66     39.7  ± 11.67  
Gender  
[units: Participants]
     
Female     162     171     333  
Male     233     232     465  



  Outcome Measures
  Show All Outcome Measures

1.  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   [ Time Frame: 6 months ]

2.  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   [ Time Frame: Baseline and Month 12 ]

3.  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   [ Time Frame: Baseline and Month 12 ]

4.  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.   [ Time Frame: Baseline and 12 months ]

5.  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.   [ Time Frame: Baseline and 12 months ]

6.  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.   [ Time Frame: Baseline and 12 months ]

7.  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.   [ Time Frame: Baseline and 12 months ]

8.  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.   [ Time Frame: Baseline and 12 months ]

9.  Secondary:   The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population   [ Time Frame: 12 months ]

10.  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).   [ Time Frame: 12 months ]

11.  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   [ Time Frame: 12 months ]

12.  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   [ Time Frame: 12 months ]

13.  Secondary:   The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population   [ Time Frame: 12 months ]

14.  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.   [ Time Frame: 12 months ]

15.  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   [ Time Frame: 12 months ]

16.  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   [ Time Frame: 12 months ]

17.  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   [ Time Frame: 12 months ]

18.  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   [ Time Frame: Month 12 ]

19.  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   [ Time Frame: 12 months ]

20.  Secondary:   Number of Participants Using Antidepressants at Month 12 in the ITT Population   [ Time Frame: 12 months ]

21.  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   [ Time Frame: 12 months ]

22.  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   [ Time Frame: 12 months ]

23.  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   [ Time Frame: 12 months ]

24.  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   [ Time Frame: 12 months ]

25.  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   [ Time Frame: 12 months ]

26.  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   [ Time Frame: 12 months ]

27.  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   [ Time Frame: 12 months ]

28.  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   [ Time Frame: 12 months ]

29.  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   [ Time Frame: 12 months ]

30.  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   [ Time Frame: Month 12 ]

31.  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   [ Time Frame: Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: clinicaltrialtransparency@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00600756     History of Changes
Other Study ID Numbers: D1443L00039
Study First Received: January 9, 2008
Results First Received: October 20, 2010
Last Updated: October 2, 2012
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Brazil: Ministry of Health
Bulgaria: Ministry of Health
Costa Rica: Ministry of Health Costa Rica
Denmark: The Ministry of the Interior and Health
Finland: Ministry of Social Affairs and Health
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Institute of Health
Mexico: National Institute of Public Health, Health Secretariat
Portugal: National Pharmacy and Medicines Institute
Romania: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
Spain: Ministry of Health and Consumption
Switzerland: Federal Office of Public Health
Turkey: Ministry of Health