TY - JOUR

T1 - The optimization of treatment and management of schizophrenia in Europe (OPTiMiSE) trial

T2 - rationale for its methodology and a review of the effectiveness of switching antipsychotics

AU - Leucht, Stefan

AU - Winter-van Rossum, Inge

AU - Heres, Stephan

AU - Arango, Celso

AU - Fleischhacker, W Wolfgang

AU - Glenthøj, Birte

AU - Leboyer, Marion

AU - Leweke, F Markus

AU - Lewis, Shôn

AU - McGuire, Phillip

AU - Meyer-Lindenberg, Andreas

AU - Rujescu, Dan

AU - Kapur, Shitij

AU - Kahn, René S

AU - Sommer, Iris E

N1 - © 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.

PY - 2015

Y1 - 2015

N2 - 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 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.

AB - 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 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.

KW - Adult

KW - Antipsychotic Agents

KW - Benzodiazepines

KW - Clinical Trials as Topic

KW - Clinical Trials, Phase III as Topic

KW - Disease Management

KW - Europe

KW - Humans

KW - Multicenter Studies as Topic

KW - Outcome Assessment (Health Care)

KW - Psychotic Disorders

KW - Randomized Controlled Trials as Topic

KW - Schizophrenia

KW - Sulpiride

U2 - 10.1093/schbul/sbv019

DO - 10.1093/schbul/sbv019

M3 - Journal article

C2 - 25786408

VL - 41

SP - 549

EP - 558

JO - Schizophrenia Bulletin

JF - Schizophrenia Bulletin

SN - 0586-7614

IS - 3

ER -