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

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

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

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

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 ]