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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00600756
• Date of registration: 09/01/2008
• Primary sponsor: AstraZeneca
• Public title: Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone RECOVER
• Scientific 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
• Date of first enrolment: January 2008
• Target sample size: 798
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00600756
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

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

Contacts

• Name: Martin Brecher, MSD
• Affiliation: AstraZeneca

• Name: Prof Naber, MD
• Affiliation: Klinikum Eppendorf

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenic Disorders

Intervention(s)

Drug: Quetiapine XR

Drug: Risperidone

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

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]

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]

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]

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]

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]

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]

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

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]

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]

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]

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]

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]

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

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]

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]

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]

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]

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Secondary ID(s)

D1443L00039

Source(s) of Monetary Support

Please refer to primary and secondary sponsors