Trial · NCT00600756
Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone
NCT00600756, Phase 3, Completed, AstraZeneca; results first posted 2012-09-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone. Trials, record NCT00600756. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00600756
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone
- NCT number
- NCT00600756
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 798 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Schizophrenic Disorders
- Interventions
- Quetiapine XR, Risperidone
- First posted
- 2008-01-25
- Last updated
- 2012-10-05
- Results first posted
- 2012-09-12
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 6 months | 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 | Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population | Baseline and Month 12 | 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. |
| 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 | Baseline and Month 12 | 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. |
| 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. | Baseline and 12 months | 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. |
| 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. | Baseline and 12 months | 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. |
| 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. | Baseline and 12 months | 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. |
| 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. | Baseline and 12 months | 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. |
| 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. | Baseline and 12 months | 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. |
| Secondary | The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population | 12 months | 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 |
| 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). | 12 months | 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. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | 6 months | 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). | Participants | NUMBER |
| 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 | Baseline and Month 12 | 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). | Scores on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline and Month 12 | 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). | Scores on a scale | LEAST_SQUARES_MEAN |
| 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. | Baseline and 12 months | 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. | Scores on a scale | LEAST_SQUARES_MEAN |
| 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. | Baseline and 12 months | 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. | Scores on a scale | LEAST_SQUARES_MEAN |
| 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. | Baseline and 12 months | 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. | Scores on a scale | LEAST_SQUARES_MEAN |
| 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. | Baseline and 12 months | 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. | Scores on a scale | LEAST_SQUARES_MEAN |
| 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. | Baseline and 12 months | 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. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population | 12 months | 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. | Participants | NUMBER |
| 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). | 12 months | 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. | Participants | NUMBER |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score | Quetiapine XR | 136 | Participants | ||
| Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score | Risperidone | 158 | Participants | ||
| Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population | Quetiapine XR | 23.2 | Standard Error 1.55 | Scores on a scale | |
| Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population | Risperidone | 21.1 | Standard Error 1.49 | Scores on a scale | |
| 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 | Quetiapine XR | 22.7 | Standard Error 1.34 | Scores on a scale | |
| 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 | Risperidone | 19.4 | Standard Error 1.0 | Scores on a scale | |
| 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. | Quetiapine XR | 4.9 | Standard Error 0.32 | Scores on a scale | |
| 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. | Risperidone | 4.0 | Standard Error 0.31 | Scores on a scale | |
| 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. | Quetiapine XR | 4.6 | Standard Error 0.32 | Scores on a scale | |
| 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. | Risperidone | 4.0 | Standard Error 0.31 | Scores on a scale |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Analysis After 6 Months | STARTED | Quetiapine XR | 395 | |
| Analysis After 6 Months | STARTED | Risperidone | 403 | |
| Analysis After 6 Months | COMPLETED | Quetiapine XR | 264 | |
| Analysis After 6 Months | COMPLETED | Risperidone | 283 | |
| Analysis After 6 Months | NOT COMPLETED | Quetiapine XR | 131 | |
| Analysis After 6 Months | NOT COMPLETED | Risperidone | 120 | |
| Overall Study Analysis After 12 Months | STARTED | Quetiapine XR | 395 | |
| Overall Study Analysis After 12 Months | STARTED | Risperidone | 403 | |
| Overall Study Analysis After 12 Months | Randomized Analysis | Quetiapine XR | 395 | |
| Overall Study Analysis After 12 Months | Randomized Analysis | Risperidone | 403 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events98
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | Quetiapine XR | 71 | 391 | |
| other | Somnolence | Nervous system disorders | Risperidone | 47 | 402 | |
| other | Headache | Nervous system disorders | Quetiapine XR | 23 | 391 | |
| other | Headache | Nervous system disorders | Risperidone | 39 | 402 | |
| other | Dizziness Postural | Nervous system disorders | Quetiapine XR | 23 | 391 | |
| other | Dizziness Postural | Nervous system disorders | Risperidone | 18 | 402 | |
| other | Sedation | Nervous system disorders | Quetiapine XR | 25 | 391 | |
| other | Sedation | Nervous system disorders | Risperidone | 15 | 402 | |
| other | Tremor | Nervous system disorders | Quetiapine XR | 7 | 391 | |
| other | Tremor | Nervous system disorders | Risperidone | 29 | 402 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Quetiapine XR | ||
| Total, all-cause mortality | Risperidone | ||
| Total, other adverse events | Quetiapine XR | 238 | 391 |
| Total, other adverse events | Risperidone | 258 | 402 |
| Total, serious adverse events | Quetiapine XR | 45 | 391 |
| Total, serious adverse events | Risperidone | 26 | 402 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23953270 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons17
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Quetiapine XR vs Risperidone: 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 | Trial comparisons |
Quetiapine XR vs Risperidone: 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 | Trial comparisons |
| Quetiapine XR vs Risperidone: Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score | Trial comparisons |
Quetiapine XR vs Risperidone: 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 | Trial comparisons |
| Quetiapine XR vs Risperidone: The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population | Trial comparisons |
| Quetiapine XR vs Risperidone: The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population | Trial comparisons |
Quetiapine XR vs Risperidone: 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 | Trial comparisons |
Quetiapine XR vs Risperidone: 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 | Trial comparisons |
| Quetiapine XR vs Risperidone: 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 | Trial comparisons |
Quetiapine XR vs Risperidone: 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 | Trial comparisons |
1 to 10 of 17
See all 17 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00600756
GET https://conductscience.org/api/trials/v1/NCT00600756/registered?page=2