Subjective well-being in schizophrenia
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Subjective well-being in schizophrenia : a randomised controlled open-label 12-month non-inferiority study comparing quetiapine XR with risperidone (RECOVER). / Naber, Dieter; Peuskens, Joseph; Schwarzmann, Nadine; Goltz, Marc; Krüger, Hagen; Lambert, Martin; Haro, Josep Maria.
In: EUR NEUROPSYCHOPHARM, Vol. 23, No. 10, 01.10.2013, p. 1257-69.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Subjective well-being in schizophrenia
T2 - a randomised controlled open-label 12-month non-inferiority study comparing quetiapine XR with risperidone (RECOVER)
AU - Naber, Dieter
AU - Peuskens, Joseph
AU - Schwarzmann, Nadine
AU - Goltz, Marc
AU - Krüger, Hagen
AU - Lambert, Martin
AU - Haro, Josep Maria
N1 - © 2013 Elsevier B.V. and ECNP. All rights reserved.
PY - 2013/10/1
Y1 - 2013/10/1
N2 - UNLABELLED: This randomised 12-month open study analysed the effectiveness of quetiapine XR (400-800 mg) versus risperidone (2-6 mg) on subjective well-being in schizophrenia (NCT00600756). Primary objective was to demonstrate non-inferiority of quetiapine XR to risperidone in 6-month responder rate using the Subjective Well-Being under Neuroleptics scale (SWN-K) (per-protocol at Month 6 [PP 6] population). Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) greater than -9.7% for the adjusted difference between quetiapine XR and risperidone. Secondary objectives included non-inferiority of quetiapine XR versus risperidone (lower limit of 95% CI greater than -7.5 points) for SWN-K change from baseline to Month 12 (PP 12). 798 patients were randomised (quetiapine XR, n=395; risperidone, n=403); at Month 12, 212 (54%) and 227 (56%) patients, respectively, completed the study. At Month 6, SWN-K responder rate in the PP 6 population was 65% (136/210) with quetiapine XR and 68% (158/232) with risperidone (adjusted treatment difference: -5.7%; 95% CI: -15.1, 3.7); thus, non-inferiority could not be established. SWN-K change from baseline to Month 12 was 23.2 points for quetiapine XR and 21.1 points for the risperidone group; treatment difference was 2.1 (95% CI: -0.8; 5.0); non-inferiority was established (PP 12).CONCLUSION: SWN-K response at 6 months was comparable between the two antipsychotics. However, with a lower than expected responder rate and a lower than expected number of evaluable patients in the PP 6 population, non-inferiority was not demonstrated. A secondary objective (SWN-K total score) established non-inferiority of quetiapine XR to risperidone at Month 12.
AB - UNLABELLED: This randomised 12-month open study analysed the effectiveness of quetiapine XR (400-800 mg) versus risperidone (2-6 mg) on subjective well-being in schizophrenia (NCT00600756). Primary objective was to demonstrate non-inferiority of quetiapine XR to risperidone in 6-month responder rate using the Subjective Well-Being under Neuroleptics scale (SWN-K) (per-protocol at Month 6 [PP 6] population). Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) greater than -9.7% for the adjusted difference between quetiapine XR and risperidone. Secondary objectives included non-inferiority of quetiapine XR versus risperidone (lower limit of 95% CI greater than -7.5 points) for SWN-K change from baseline to Month 12 (PP 12). 798 patients were randomised (quetiapine XR, n=395; risperidone, n=403); at Month 12, 212 (54%) and 227 (56%) patients, respectively, completed the study. At Month 6, SWN-K responder rate in the PP 6 population was 65% (136/210) with quetiapine XR and 68% (158/232) with risperidone (adjusted treatment difference: -5.7%; 95% CI: -15.1, 3.7); thus, non-inferiority could not be established. SWN-K change from baseline to Month 12 was 23.2 points for quetiapine XR and 21.1 points for the risperidone group; treatment difference was 2.1 (95% CI: -0.8; 5.0); non-inferiority was established (PP 12).CONCLUSION: SWN-K response at 6 months was comparable between the two antipsychotics. However, with a lower than expected responder rate and a lower than expected number of evaluable patients in the PP 6 population, non-inferiority was not demonstrated. A secondary objective (SWN-K total score) established non-inferiority of quetiapine XR to risperidone at Month 12.
KW - Adult
KW - Antipsychotic Agents
KW - Delayed-Action Preparations
KW - Diagnostic and Statistical Manual of Mental Disorders
KW - Dibenzothiazepines
KW - Drug Monitoring
KW - Drug Resistance
KW - Extrapyramidal Tracts
KW - Female
KW - Humans
KW - Incidence
KW - Intention to Treat Analysis
KW - Lost to Follow-Up
KW - Male
KW - Middle Aged
KW - Quality of Life
KW - Risperidone
KW - Schizophrenia
KW - Schizophrenic Psychology
KW - Therapeutic Equivalency
U2 - 10.1016/j.euroneuro.2013.07.006
DO - 10.1016/j.euroneuro.2013.07.006
M3 - SCORING: Journal article
C2 - 23953270
VL - 23
SP - 1257
EP - 1269
JO - EUR NEUROPSYCHOPHARM
JF - EUR NEUROPSYCHOPHARM
SN - 0924-977X
IS - 10
ER -
