The optimization of treatment and management of schizophrenia in Europe (OPTiMiSE) trial: rationale for its methodology and a review of the effectiveness of switching antipsychotics
Leucht, Stefan; Winter-van Rossum, Inge; Heres, Stephan; Arango, Celso; Fleischhacker, W Wolfgang; Glenthøj, Birte; Leboyer, Marion; Leweke, F Markus; Lewis, Shôn; McGuire, Phillip; Meyer-Lindenberg, Andreas; Rujescu, Dan; Kapur, Shitij; Kahn, René S; Sommer, Iris E
(2015) Schizophrenia Bulletin, volume 41, issue 3, pp. 549 - 558
(Article)
Abstract
BACKGROUND: Most of the 13 542 trials contained in the Cochrane Schizophrenia Group's register just tested the general efficacy of pharmacological or psychosocial interventions. Studies on the subsequent treatment steps, which are essential to guide clinicians, are largely missing. This knowledge gap leaves important questions unanswered. For example, when a
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first antipsychotic failed, is switching to another drug effective? And when should we use clozapine? The aim of this article is to review the efficacy of switching antipsychotics in case of nonresponse. We also present the European Commission sponsored "Optimization of Treatment and Management of Schizophrenia in Europe" (OPTiMiSE) trial which aims to provide a treatment algorithm for patients with a first episode of schizophrenia. METHODS: We searched Pubmed (October 29, 2014) for randomized controlled trials (RCTs) that examined switching the drug in nonresponders to another antipsychotic. We described important methodological choices of the OPTiMiSE trial. RESULTS: We found 10 RCTs on switching antipsychotic drugs. No trial was conclusive and none was concerned with first-episode schizophrenia. In OPTiMiSE, 500 first episode patients are treated with amisulpride for 4 weeks, followed by a 6-week double-blind RCT comparing continuation of amisulpride with switching to olanzapine and ultimately a 12-week clozapine treatment in nonremitters. A subsequent 1-year RCT validates psychosocial interventions to enhance adherence. DISCUSSION: Current literature fails to provide basic guidance for the pharmacological treatment of schizophrenia. The OPTiMiSE trial is expected to provide a basis for clinical guidelines to treat patients with a first episode of schizophrenia.
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Keywords: Adult, Antipsychotic Agents, Benzodiazepines, Clinical Trials as Topic, Clinical Trials, Phase III as Topic, Disease Management, Europe, Humans, Multicenter Studies as Topic, Outcome Assessment (Health Care), Psychotic Disorders, Randomized Controlled Trials as Topic, Schizophrenia, Sulpiride, Research Support, Non-U.S. Gov't, first episode, amisulpride, olanzapine, algorithm, nonresponse, Journal Article, Research Support, Non-U.S. Gov't, Review
ISSN: 0586-7614
Publisher: Oxford University Press
Note: © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.
(Peer reviewed)