P Conus1, M Berk2, S M Cotton3, L Kader3, C Macneil3, M K Hasty3, K Hallam3, M Lambert4, B P Murphy5, P D McGorry3. 1. Treatment and Early Intervention in Psychosis Program (TIPP), département de psychiatrie CHUV, université de Lausanne, clinique de Cery, 1008 Prilly, Switzerland; Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne, 35 Poplar Road, Parkville Victoria 3052, Melbourne, Australia. Electronic address: philippe.conus@chuv.ch. 2. Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne, 35 Poplar Road, Parkville Victoria 3052, Melbourne, Australia; Department of Clinical and Biomedical Sciences, Barwon Health, University of Melbourne, Geelong, Australia; Mental Health Research Institute, Parkville, Australia. 3. Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne, 35 Poplar Road, Parkville Victoria 3052, Melbourne, Australia. 4. Department for Psychiatry and Psychotherapy, Psychosis Early Detection and Intervention Centre (PEDIC), Centre for Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 5. Faculty of Medicine, Nursing and Health Sciences, School of Psychology, Psychiatry and Psychological Medicine, Monash University, Victoria 3800, Australia.
Abstract
BACKGROUND: Treatment strategies for mental disorders may vary according to illness stage. However no data currently exist to guide treatment in first episode psychotic mania. The aim of this study was to compare the safety and efficacy profile of chlorpromazine and olanzapine, as add-on to lithium, in patients with a first episode of psychotic mania, expecting better safety profile and adherence to olanzapine but similar efficacy for both treatments. METHODS: Data from 83 patients were collected in an 8-week randomised controlled trial on clinical variables, side effects, vital signs, and weight. Analyses of treatment differences over time were based on intent-to-treat principles. Kaplan-Meier estimated survival curves were used to analyse time-to-event data and mixed effects models repeated measures analysis of variance were used to determine treatment group differences over time on safety and efficacy measures. RESULTS: Ethics committee approval to delay informed consent procedure until recovery from the acute episode allowed the inclusion of 83 patients highly representative of those treated in the public sector. Contrary to our hypotheses, safety profile of both medications was similar. A signal for higher rate (P=.032) and earlier occurrence (P=.043) of mania remission was observed in the olanzapine group which did not survive correction for multiple comparisons. CONCLUSIONS:Olanzapine and chlorpromazine have a similar safety profile in a uniquely representative cohort of patients with first episode psychotic mania. The possibility for a greater impact of olanzapine on manic symptoms leading to earlier remission of the episode needs exploration in a large sample.
RCT Entities:
BACKGROUND: Treatment strategies for mental disorders may vary according to illness stage. However no data currently exist to guide treatment in first episode psychotic mania. The aim of this study was to compare the safety and efficacy profile of chlorpromazine and olanzapine, as add-on to lithium, in patients with a first episode of psychotic mania, expecting better safety profile and adherence to olanzapine but similar efficacy for both treatments. METHODS: Data from 83 patients were collected in an 8-week randomised controlled trial on clinical variables, side effects, vital signs, and weight. Analyses of treatment differences over time were based on intent-to-treat principles. Kaplan-Meier estimated survival curves were used to analyse time-to-event data and mixed effects models repeated measures analysis of variance were used to determine treatment group differences over time on safety and efficacy measures. RESULTS: Ethics committee approval to delay informed consent procedure until recovery from the acute episode allowed the inclusion of 83 patients highly representative of those treated in the public sector. Contrary to our hypotheses, safety profile of both medications was similar. A signal for higher rate (P=.032) and earlier occurrence (P=.043) of mania remission was observed in the olanzapine group which did not survive correction for multiple comparisons. CONCLUSIONS:Olanzapine and chlorpromazine have a similar safety profile in a uniquely representative cohort of patients with first episode psychotic mania. The possibility for a greater impact of olanzapine on manic symptoms leading to earlier remission of the episode needs exploration in a large sample.
Authors: Michael Berk; Robert Post; Aswin Ratheesh; Emma Gliddon; Ajeet Singh; Eduard Vieta; Andre F Carvalho; Melanie M Ashton; Lesley Berk; Susan M Cotton; Patrick D McGorry; Brisa S Fernandes; Lakshmi N Yatham; Seetal Dodd Journal: World Psychiatry Date: 2017-10 Impact factor: 49.548
Authors: Roger S McIntyre; Martin Alda; Ross J Baldessarini; Michael Bauer; Michael Berk; Christoph U Correll; Andrea Fagiolini; Kostas Fountoulakis; Mark A Frye; Heinz Grunze; Lars V Kessing; David J Miklowitz; Gordon Parker; Robert M Post; Alan C Swann; Trisha Suppes; Eduard Vieta; Allan Young; Mario Maj Journal: World Psychiatry Date: 2022-10 Impact factor: 79.683