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: [email protected].
PY - 2015/5/1
Y1 - 2015/5/1
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
SN - 0586-7614
VL - 41
SP - 549
EP - 558
JO - Schizophrenia Bulletin
JF - Schizophrenia Bulletin
IS - 3
ER -