Phase 3
Completed N=798
Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone
Schizophrenic Disorders
Source: ClinicalTrials.gov NCT00600756 ↗
Enrolled (actual)
798
Serious AEs
9.0%
Results posted
Sep 2012
Primary outcomePrimary: 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; 158 Participants
Summary
The trial is designed to assess the long term subjective well-being in schizophrenic outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible dose in a naturalistic setting over a period of one year. Secondary outcome measures have been selected for helping in the differentiation of the compared atypical antipsychotics. The primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to risperidone assessed at month 6 in terms of responder rate using the self-report instrument SWN-K
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
136; 158 | — |
| 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 |
23.2; 21.1 | — |
| 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 |
22.7; 19.4 | — |
| 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. |
4.9; 4.0 | — |
| 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. |
4.6; 4.0 | — |
| 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. |
4.9; 3.9 | — |
| 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. |
4.1; 3.8 | — |
| 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. |
4.5; 3.9 | — |
| SECONDARY The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population |
139; 128 | — |
| 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). |
176; 178 | — |
| 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 |
3.8; 3.9 | — |
| 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 |
-4.7; -3.7 | — |
| SECONDARY The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population |
43; 31 | — |
| 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. |
0.193; 0.168 | — |
| 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 |
160; 171 | — |
| 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 |
10; 6.7 | — |
| 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 |
37; 21 | — |
| 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 |
94; 70 | — |
| 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 |
144.3; 152.8 | — |
| SECONDARY Number of Participants Using Antidepressants at Month 12 in the ITT Population |
72; 63 | — |
| 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 |
138; 141 | — |
| 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 |
270; 249 | — |
| 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 |
238; 258 | — |
| 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 |
57; 48 | — |
| 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 |
38; 83 | — |
| 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 |
51; 112 | — |
| 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 |
22; 17 | — |
| 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 |
-7.735; 15.990 | — |
| 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 |
4; 20 | — |
| 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 |
0; 10 | — |
| 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 |
9; 13 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00600756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.