Trial Outcomes & Findings for Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone (NCT NCT00600756)
NCT ID: NCT00600756
Last Updated: 2012-10-05
Results Overview
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)
COMPLETED
PHASE3
798 participants
6 months
2012-10-05
Participant Flow
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.
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!
Participant milestones
| Measure |
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
|
|---|---|---|
|
Analysis After 6 Months
STARTED
|
395
|
403
|
|
Analysis After 6 Months
COMPLETED
|
264
|
283
|
|
Analysis After 6 Months
NOT COMPLETED
|
131
|
120
|
|
Overall Study Analysis After 12 Months
STARTED
|
395
|
403
|
|
Overall Study Analysis After 12 Months
Randomized Analysis
|
395
|
403
|
|
Overall Study Analysis After 12 Months
Safety Analysis
|
391
|
402
|
|
Overall Study Analysis After 12 Months
ITT Analysis
|
379
|
392
|
|
Overall Study Analysis After 12 Months
COMPLETED
|
212
|
227
|
|
Overall Study Analysis After 12 Months
NOT COMPLETED
|
183
|
176
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Analysis After 6 Months
Adverse Event
|
43
|
33
|
|
Analysis After 6 Months
Withdrawal by Subject
|
38
|
30
|
|
Analysis After 6 Months
Incorrect Enrollment
|
12
|
21
|
|
Analysis After 6 Months
worsening symptom, lack of efficacy
|
11
|
14
|
|
Analysis After 6 Months
Severe non-compliance to protocol
|
11
|
11
|
|
Analysis After 6 Months
Lost to Follow-up
|
10
|
8
|
|
Analysis After 6 Months
Study-specific discontinuation criteria
|
6
|
3
|
|
Overall Study Analysis After 12 Months
Adverse Event
|
53
|
44
|
|
Overall Study Analysis After 12 Months
Withdrawal by Subject
|
51
|
41
|
|
Overall Study Analysis After 12 Months
Incorrect enrollment
|
21
|
29
|
|
Overall Study Analysis After 12 Months
worsening symptom, lack of efficacy
|
17
|
20
|
|
Overall Study Analysis After 12 Months
Severe non-compliance to protocol
|
16
|
20
|
|
Overall Study Analysis After 12 Months
Lost to Follow-up
|
16
|
13
|
|
Overall Study Analysis After 12 Months
Study-specific discontinuation criteria
|
9
|
9
|
Baseline Characteristics
Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone
Baseline characteristics by cohort
| Measure |
Quetiapine XR
n=395 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=403 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
Total
n=798 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
39.3 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
40.0 Years
STANDARD_DEVIATION 11.66 • n=7 Participants
|
39.7 Years
STANDARD_DEVIATION 11.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
162 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
333 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
233 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
465 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: For Per Protocol at Month 6 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (169) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (160).
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)
Outcome measures
| Measure |
Quetiapine XR
n=210 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=232 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score
|
136 Participants
|
158 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: For Per Protocol at Month 12 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (206) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (201).
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.
Outcome measures
| Measure |
Quetiapine XR
n=173 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=191 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population
|
23.2 Scores on a scale
Standard Error 1.55
|
21.1 Scores on a scale
Standard Error 1.49
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: For Per Protocol at Month 12 analysis, the difference from Randomized analysis (395) was no study drug (4); SWN-K score missing (12), and did not meet inclusion criteria (206) for Quetiapine XR. For Risperidone, the difference from Randomized analysis (403) was no study drug (1); SWN-K score missing (10), and did not meet inclusion criteria (201).
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.
Outcome measures
| Measure |
Quetiapine XR
n=379 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=392 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
22.7 Scores on a scale
Standard Error 1.34
|
19.4 Scores on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
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.
Outcome measures
| Measure |
Quetiapine XR
n=379 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=392 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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.
|
4.9 Scores on a scale
Standard Error 0.32
|
4.0 Scores on a scale
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
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.
Outcome measures
| Measure |
Quetiapine XR
n=379 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=392 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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.
|
4.6 Scores on a scale
Standard Error 0.32
|
4.0 Scores on a scale
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
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.
Outcome measures
| Measure |
Quetiapine XR
n=379 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=392 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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.
|
4.9 Scores on a scale
Standard Error 0.31
|
3.9 Scores on a scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
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.
Outcome measures
| Measure |
Quetiapine XR
n=379 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=392 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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.
|
4.1 Scores on a scale
Standard Error 0.29
|
3.8 Scores on a scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
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.
Outcome measures
| Measure |
Quetiapine XR
n=379 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=392 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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.
|
4.5 Scores on a scale
Standard Error 0.32
|
3.9 Scores on a scale
Standard Error 0.31
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
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
Outcome measures
| Measure |
Quetiapine XR
n=210 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=227 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population
|
139 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
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.
Outcome measures
| Measure |
Quetiapine XR
n=211 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=227 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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).
|
176 Participants
1.46
|
178 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
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).
Outcome measures
| Measure |
Quetiapine XR
n=211 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=227 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
3.8 Scores on a scale
Standard Deviation 0.63
|
3.9 Scores on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
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.
Outcome measures
| Measure |
Quetiapine XR
n=351 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=362 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
-4.7 Scores on a scale
Standard Error 0.26
|
-3.7 Scores on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Reported population is participants who showed relapse over time, from baseline to Month 12.
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.
Outcome measures
| Measure |
Quetiapine XR
n=379 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=392 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population
|
43 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
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).
Outcome measures
| Measure |
Quetiapine XR
n=343 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=360 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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.
|
0.193 Scores on a scale
Standard Error 0.0167
|
0.168 Scores on a scale
Standard Error 0.0162
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
Stable State was defined as having the same status in occupational and residential status as at Baseline.
Outcome measures
| Measure |
Quetiapine XR
n=268 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=291 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
160 Participants with stable state
|
171 Participants with stable state
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
Workers and students are defined from the modified vocational status index excluding subjects "Retired" or "Unemployed, whether or not expected to work".
Outcome measures
| Measure |
Quetiapine XR
n=158 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=169 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
10 Days
Standard Deviation 38.54
|
6.7 Days
Standard Deviation 30.53
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
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.
Outcome measures
| Measure |
Quetiapine XR
n=379 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=392 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
37 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Month 12Population: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
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.
Outcome measures
| Measure |
Quetiapine XR
n=379 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=392 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
94 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
Outcome measures
| Measure |
Quetiapine XR
n=35 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=19 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
144.3 Days
Standard Deviation 97.14
|
152.8 Days
Standard Deviation 87.86
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
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".
Outcome measures
| Measure |
Quetiapine XR
n=379 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=392 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
Number of Participants Using Antidepressants at Month 12 in the ITT Population
|
72 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
Other psychotropic medications include antiepileptics, anti-parkinson drugs, antipsychotics, and antidepressants.
Outcome measures
| Measure |
Quetiapine XR
n=379 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=392 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
138 Participants
|
141 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The ITT analysis set at Month 12 is presented. For Quetiapine XR, there were 168 missing CGI-SCH assessments, resulting in 211 evaluable subjects at Month 12. For Risperidone, there were 165 missing CGI-SCH assessments, resulting in 227 evaluable subjects at Month 12.
Outcome measures
| Measure |
Quetiapine XR
n=379 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=392 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
270 Participants
|
249 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).
Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).
Outcome measures
| Measure |
Quetiapine XR
n=391 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=402 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
238 Participants
|
258 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).
Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).
Outcome measures
| Measure |
Quetiapine XR
n=391 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=402 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
57 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).
Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).
Outcome measures
| Measure |
Quetiapine XR
n=391 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=402 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
38 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).
Extra-pyramidal events include tremor, hypokinesia, muscle rigidity, hyperkinesia, and extrapyramidal disorder.
Outcome measures
| Measure |
Quetiapine XR
n=391 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=402 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Extra-pyramidal Events at Month 12 in the Safety Population
|
51 Events
|
112 Events
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).
Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day).
Outcome measures
| Measure |
Quetiapine XR
n=391 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=402 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
22 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).
The normal range for men is 0 to 14, and for women is 0 to 24.
Outcome measures
| Measure |
Quetiapine XR
n=332 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=340 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
-7.735 ng/mL
Standard Deviation 32.8559
|
15.990 ng/mL
Standard Deviation 46.3367
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Safety population at Month 12 is presented. For Quetiapine XR, 4 subjects did not take study drug, resulting in 391 evaluable subjects compared with the Randomized population (395 subjects). For Risperidone, 1 subject did not take study drug, results in 402 evaluable subjects compared with the Randomized population (403 subjects).
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.
Outcome measures
| Measure |
Quetiapine XR
n=209 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=224 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
4 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Month 12Population: Safety population at Month 12 is presented. Quetiapine XR: Out of 160 evaluable women, 73 were missing individual AE "Hyperprolactinaemia" data. Risperidone: Out of 171 evaluable women, 74 were missing individual AE "Hyperprolactinaemia" data".
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.
Outcome measures
| Measure |
Quetiapine XR
n=87 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=97 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
0 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Month 12Population: Safety population at Month 12 is presented. Quetiapine XR: Out of 231 evaluable men, 111 were missing individual AE "Sexual Dysfunction" data". Risperidone: Out of 231 evaluable men, 106 were missing individual AE "Sexual Dysfunction" data".
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.
Outcome measures
| Measure |
Quetiapine XR
n=120 Participants
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=125 Participants
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
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
|
9 Participants
|
13 Participants
|
Adverse Events
Quetiapine XR
Risperidone
Serious adverse events
| Measure |
Quetiapine XR
n=391 participants at risk
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=402 participants at risk
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
Psychiatric disorders
Schizophrenia
|
3.1%
12/391
|
1.2%
5/402
|
|
Psychiatric disorders
Psychotic Disorder
|
2.3%
9/391
|
1.2%
5/402
|
|
Psychiatric disorders
Abnormal Behavior
|
0.51%
2/391
|
0.25%
1/402
|
|
Psychiatric disorders
Acute Psychosis
|
0.51%
2/391
|
0.25%
1/402
|
|
Psychiatric disorders
Agitation
|
0.77%
3/391
|
0.00%
0/402
|
|
Psychiatric disorders
Depression
|
0.51%
2/391
|
0.25%
1/402
|
|
Psychiatric disorders
Suicide Attempt
|
0.77%
3/391
|
0.00%
0/402
|
|
Psychiatric disorders
Aggression
|
0.26%
1/391
|
0.25%
1/402
|
|
Psychiatric disorders
Alcohol Abuse
|
0.26%
1/391
|
0.25%
1/402
|
|
Psychiatric disorders
Schizoaffective Disorder
|
0.26%
1/391
|
0.25%
1/402
|
|
Psychiatric disorders
Anxiety
|
0.26%
1/391
|
0.00%
0/402
|
|
Psychiatric disorders
Confusional State
|
0.26%
1/391
|
0.00%
0/402
|
|
Psychiatric disorders
Delusion
|
0.00%
0/391
|
0.25%
1/402
|
|
Psychiatric disorders
Mental Disorder
|
0.26%
1/391
|
0.00%
0/402
|
|
Psychiatric disorders
Panic Attack
|
0.26%
1/391
|
0.00%
0/402
|
|
Psychiatric disorders
Schizophreniform Disorder
|
0.26%
1/391
|
0.00%
0/402
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/391
|
0.25%
1/402
|
|
Nervous system disorders
Brain Stem Stroke
|
0.00%
0/391
|
0.25%
1/402
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/391
|
0.25%
1/402
|
|
Nervous system disorders
Extrapyramidal Disorder
|
0.00%
0/391
|
0.25%
1/402
|
|
Nervous system disorders
Ischaemic Stroke
|
0.26%
1/391
|
0.00%
0/402
|
|
Nervous system disorders
Neuroleptic Malignant Syndrome
|
0.00%
0/391
|
0.25%
1/402
|
|
Nervous system disorders
Psychomotor Hyperactivity
|
0.26%
1/391
|
0.00%
0/402
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/391
|
0.25%
1/402
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.26%
1/391
|
0.00%
0/402
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.26%
1/391
|
0.00%
0/402
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/391
|
0.25%
1/402
|
|
Metabolism and nutrition disorders
Diabetes Meelitus
|
0.00%
0/391
|
0.25%
1/402
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone Neoplasm Malignant
|
0.26%
1/391
|
0.00%
0/402
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary Tumor Benign
|
0.00%
0/391
|
0.25%
1/402
|
|
Gastrointestinal disorders
Constipation
|
0.26%
1/391
|
0.00%
0/402
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/391
|
0.25%
1/402
|
|
Infections and infestations
Appendicitis
|
0.26%
1/391
|
0.00%
0/402
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/391
|
0.25%
1/402
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/391
|
0.25%
1/402
|
|
Investigations
Osteoarthritis
|
0.26%
1/391
|
0.00%
0/402
|
Other adverse events
| Measure |
Quetiapine XR
n=391 participants at risk
Experimental - oral, once daily, tablets of 400 mg to 800 mg
|
Risperidone
n=402 participants at risk
Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
|
|---|---|---|
|
Nervous system disorders
Somnolence
|
18.2%
71/391
|
11.7%
47/402
|
|
Nervous system disorders
Headache
|
5.9%
23/391
|
9.7%
39/402
|
|
Nervous system disorders
Dizziness Postural
|
5.9%
23/391
|
4.5%
18/402
|
|
Nervous system disorders
Sedation
|
6.4%
25/391
|
3.7%
15/402
|
|
Nervous system disorders
Tremor
|
1.8%
7/391
|
7.2%
29/402
|
|
Psychiatric disorders
Insomnia
|
7.7%
30/391
|
12.9%
52/402
|
|
Psychiatric disorders
Anxiety
|
8.4%
33/391
|
9.5%
38/402
|
|
Psychiatric disorders
Tension
|
4.6%
18/391
|
5.0%
20/402
|
|
Gastrointestinal disorders
Constipation
|
10.2%
40/391
|
5.7%
23/402
|
|
Gastrointestinal disorders
Aptyalism
|
8.4%
33/391
|
5.2%
21/402
|
|
Gastrointestinal disorders
Nausea
|
4.6%
18/391
|
6.5%
26/402
|
|
General disorders
Asthenia
|
5.6%
22/391
|
6.2%
25/402
|
|
Investigations
Weight Increased
|
4.6%
18/391
|
6.2%
25/402
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place