P03-246 - Extended-release quetiapine fumarate (quetiapine XR) versus risperidone in the treatment of depressive symptoms in schizophrenic or schizoaffective patients - 05/05/11
Résumé |
Introduction |
Depressive symptoms are associated with poor outcomes, increased risk of relapse and high suicide rates in patients with schizophrenia and schizoaffective disorder (1, 2).
Objective |
Assess the efficacy of quetiapine XR (QTP-XR) versus risperidone on depressive symptoms in schizophrenia and schizoaffective disorder.
Methods |
A randomised, open-label, parallel-group, flexible-dose study (NCT00640562).
Primary endpoint |
LSM change from baseline to Week 12 in Calgary Depression Scale for Schizophrenia (CDSS) (3) score. Secondary endpoints: change in HAM-D and PANSS scores, and adverse events (AEs). No scorrection for multiplicity was done for the secondary endpoints.
Results |
216 patients received QTP-XR (n=109; 400–800mg/day) or risperidone (n=107; 4–6mg/day). From baseline, QTP-XR significantly reduced CDSS, HAM-D and PANSS negative total scores compared with risperidone (QTP-XR vs risperidone: -7.31 versus -5.53, p=0.0107; -14.68 versus -11.53, p=0.0005; -8.23 versus -5.45, p=0.0008, respectively). No major differences in AEs were observed between QTP-XR and risperidone. Four serious AEs were experienced with QTP-XR and 5 with risperidone. Two patients receiving QTP-XR died (unrelated to study drug). Prolactin levels were significantly reduced from baseline with QTP-XR versus risperidone (-9.15ng/mL and +22.18ng/mL respectively; p<0.0001). No important differences were seen in other laboratory parameters.
Conclusions |
In this study, QTP-XR was superior to risperidone at reducing depressive symptoms in schizophrenia or schizoaffective disorder according to CDSS, HAM-D and PANSS negative scores.
Le texte complet de cet article est disponible en PDF.Vol 26 - N° S1
P. 1415 - 2011 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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