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Effectiveness, tolerability, and safety of ziprasidone in patients with schizophrenia or schizoaffective disorder: Results of a multi-centre observational trial

Published online by Cambridge University Press:  16 April 2020

Duerten Kudla ,
Martin Lambert ,
Sabine Domin ,
Siegfried Kasper  and
Dieter Naber
Duerten Kudla*
Affiliation:
Centre for Psychosocial Medicine, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246Hamburg, Germany
Martin Lambert
Affiliation:
Psychosis Early Detection and Intervention Centre (PEDIC), Centre for Psychosocial Medicine, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Sabine Domin
Affiliation:
Centre for Psychosocial Medicine, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246Hamburg, Germany
Siegfried Kasper
Affiliation:
Department of General Psychiatry, Medical University of Vienna, Vienna, Austria
Dieter Naber
Affiliation:
Centre for Psychosocial Medicine, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246Hamburg, Germany
*
*Corresponding author. Tel.: +49 40 42803 2227; fax: +49 40 42803 2999. E-mail address:[email protected] (D. Kudla).
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Abstract

Purpose

The ZEISIG study (Ziprasidone Experience in Schizophrenia in Germany/Austria) investigated the effectiveness of ziprasidone as measured by discontinuation rates and mean changes of the BPRS total. Secondary objectives included quality of life, subjective well-being, tolerability, and safety.

Subjects and methods

Two hundred and seventy-six subjects with schizophrenia and schizoaffective disorder were treated within an open-label, 12-week, prospective, flexible-dose observational trial of ziprasidone (40–160 mg/day). Baseline and outcome assessments mainly included Brief Psychiatric Rating Scale (BPRS), Clinical Global Impressions Scale (CGI), Short-Form 12 (SF-12), and Subjective Well-being under Neuroleptic treatment (SWN-K).

Results

Study discontinuation due to any cause was evident in 58% of subjects, most of them within the first 4 weeks after study initiation. In study completers, ziprasidone was associated with improvements in BPRS total (44.8 to 33.6; p < 0.001), CGI, SF-12, and SWN-K total scores (80.5 to 89.5). Ziprasidone was related to reduction of weight, fasting glucose, and serum lipids. No cardiovascular adverse event or significant increase of the QTc interval was observed.

Discussion and conclusion

Approximately 60% of subjects discontinued ziprasidone prematurely, probably related to an initial and overall underdose. The present study confirmed previous tolerability and safety data of ziprasidone as well as results of its effectiveness. Independent from reason to switch, previous antipsychotic class, and severity of illness at baseline, the recommended starting dose of 80 mg/day as well as the maximum treatment dose of 160 mg/day may not be sufficient for a selected subgroup of patients.

Keywords

SchizophreniaAtypical antipsychoticsZiprasidoneQuality of life
Type
Schizophrenia and Psychotic Disorder
Information
European Psychiatry , Volume 22 , Issue 3 , April 2007 , pp. 195 - 202
Copyright
Copyright © Elsevier Masson SAS 2007

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