OBJECTIVE: This randomized double-blind multicenter trial evaluated the effects of olanzapine vs. clozapine on subjective well-being, quality of life (QOL) and clinical outcome. METHOD: The primary objective was to demonstrate non-inferiority of olanzapine, mean dosage 16.2 +/- 4.8 (5-25 mg/day) vs. clozapine, mean dosage 209 +/- 91 (100-400 mg/day) regarding improvement on the 'Subjective Well-Being under Neuroleptic Treatment' (SWN) Scale after 26 treatment weeks in 114 patients with schizophrenia. Secondary outcome parameters included: Munich QOL Dimension List (MLDL), Positive and Negative Symptom Scale (PANSS), Clinical Global Impression (CGI). RESULTS:SWN scores improved significantly in both groups, olanzapine was non-inferior to clozapine (group difference 3.2 points in favor of olanzapine; 95% CI: 4.2;10.5). MLDL-satisfaction, PANSS and CGI-S improved similarly, olanzapine yielded a higher CGI Therapeutic Index. Individual SWN and PANSS changes correlated only moderately (r = -0.45). CONCLUSION:Olanzapine was non-inferior to clozapine. The lack of a marked correlation between PANSS and SWN improvements indicates that patients and psychiatrists perceive treatment differently.
RCT Entities:
OBJECTIVE: This randomized double-blind multicenter trial evaluated the effects of olanzapine vs. clozapine on subjective well-being, quality of life (QOL) and clinical outcome. METHOD: The primary objective was to demonstrate non-inferiority of olanzapine, mean dosage 16.2 +/- 4.8 (5-25 mg/day) vs. clozapine, mean dosage 209 +/- 91 (100-400 mg/day) regarding improvement on the 'Subjective Well-Being under Neuroleptic Treatment' (SWN) Scale after 26 treatment weeks in 114 patients with schizophrenia. Secondary outcome parameters included: Munich QOL Dimension List (MLDL), Positive and Negative Symptom Scale (PANSS), Clinical Global Impression (CGI). RESULTS: SWN scores improved significantly in both groups, olanzapine was non-inferior to clozapine (group difference 3.2 points in favor of olanzapine; 95% CI: 4.2;10.5). MLDL-satisfaction, PANSS and CGI-S improved similarly, olanzapine yielded a higher CGI Therapeutic Index. Individual SWN and PANSS changes correlated only moderately (r = -0.45). CONCLUSION:Olanzapine was non-inferior to clozapine. The lack of a marked correlation between PANSS and SWN improvements indicates that patients and psychiatrists perceive treatment differently.
Authors: Taishiro Kishimoto; Katsuhiko Hagi; Masahiro Nitta; John M Kane; Christoph U Correll Journal: World Psychiatry Date: 2019-06 Impact factor: 49.548
Authors: Christian Schmidt-Kraepelin; Sandra Feyerabend; Christina Engelke; Mathias Riesbeck; Eva Meisenzahl-Lechner; Wolfgang Gaebel; Pablo-Emilio Verde; Henrike Kolbe; Christoph U Correll; Stefan Leucht; Stephan Heres; Michael Kluge; Christian Makiol; Andrea Neff; Christina Lange; Susanne Englisch; Mathias Zink; Berthold Langguth; Timm Poeppl; Dirk Reske; Euphrosyne Gouzoulis-Mayfrank; Gerhard Gründer; Alkomiet Hasan; Anke Brockhaus-Dumke; Markus Jäger; Jessica Baumgärtner; Thomas Wobrock; Joachim Cordes Journal: Eur Arch Psychiatry Clin Neurosci Date: 2019-09-05 Impact factor: 5.270