Olanzapine or chlorpromazine plus lithium in first episode psychotic mania: An 8-week randomised controlled trial.
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.
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.
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Conus
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.
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Berk
Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne, 35 Poplar Road, Parkville Victoria 3052, Melbourne, Australia.
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Cotton
Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne, 35 Poplar Road, Parkville Victoria 3052, Melbourne, Australia.
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Kader
Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne, 35 Poplar Road, Parkville Victoria 3052, Melbourne, Australia.
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Macneil
Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne, 35 Poplar Road, Parkville Victoria 3052, Melbourne, Australia.
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Hasty
Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne, 35 Poplar Road, Parkville Victoria 3052, Melbourne, Australia.
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Hallam
Department for Psychiatry and Psychotherapy, Psychosis Early Detection and Intervention Centre (PEDIC), Centre for Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
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Lambert
Faculty of Medicine, Nursing and Health Sciences, School of Psychology, Psychiatry and Psychological Medicine, Monash University, Victoria 3800, Australia.
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Murphy
Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne, 35 Poplar Road, Parkville Victoria 3052, Melbourne, Australia.
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McGorry
D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects; D001569:Benzodiazepines / Q000008:administration & dosage / Q000009:adverse effects; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D002746:Chlorpromazine / Q000008:administration & dosage / Q000009:adverse effects; D039721:Diagnostic and Statistical Manual of Mental Disorders; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D008094:Lithium / Q000627:therapeutic use; D008297:Male; D000077152:Olanzapine; D011618:Psychotic Disorders / Q000188:drug therapy; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D001569:Benzodiazepines; D008094:Lithium; D000077152:Olanzapine; D002746:Chlorpromazine
Antipsychotic treatment; Bipolar disorder; First episode; Mania; Psychosis