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

Stefan Leucht; Inge Winter-van Rossum; Stephan Heres; Celso Arango; W Wolfgang Fleischhacker; Birte Glenthøj; Marion Leboyer; F Markus Leweke; Shôn Lewis; Phillip McGuire; Andreas Meyer-Lindenberg; Dan Rujescu; Shitij Kapur; René S Kahn; Iris E Sommer

doi:10.1093/schbul/sbv019

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

Stefan Leucht, Inge Winter-van Rossum, Stephan Heres, Celso Arango, W Wolfgang Fleischhacker, Birte Glenthøj, Marion Leboyer, F Markus Leweke, Shôn Lewis, Phillip McGuire, Andreas Meyer-Lindenberg, Dan Rujescu, Shitij Kapur, René S Kahn, Iris E Sommer

Department of Clinical Medicine

31 Citations (Scopus)

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 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.

Original language	English
Journal	Schizophrenia Bulletin
Volume	41
Issue number	3
Pages (from-to)	549-58
Number of pages	10
ISSN	0586-7614
DOIs	https://doi.org/10.1093/schbul/sbv019
Publication status	Published - 1 May 2015

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

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10.1093/schbul/sbv019

Cite this

Leucht, S., Winter-van Rossum, I., Heres, S., Arango, C., Fleischhacker, W. W., Glenthøj, B., Leboyer, M., Leweke, F. M., Lewis, S., McGuire, P., Meyer-Lindenberg, A., Rujescu, D., Kapur, S., Kahn, R. S., & Sommer, I. E. (2015). 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. Schizophrenia Bulletin, 41(3), 549-58. https://doi.org/10.1093/schbul/sbv019

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 et al.

In: Schizophrenia Bulletin, Vol. 41, No. 3, 01.05.2015, p. 549-58.

Research output: Contribution to journal › Journal article › Research › peer-review

Leucht, S, Winter-van Rossum, I, Heres, S, Arango, C, Fleischhacker, WW, Glenthøj, B, Leboyer, M, Leweke, FM, Lewis, S, McGuire, P, Meyer-Lindenberg, A, Rujescu, D, Kapur, S, Kahn, RS & Sommer, IE 2015, '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', Schizophrenia Bulletin, vol. 41, no. 3, pp. 549-58. https://doi.org/10.1093/schbul/sbv019

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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 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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author = "Stefan Leucht and {Winter-van Rossum}, Inge and Stephan Heres and Celso Arango and Fleischhacker, {W Wolfgang} and Birte Glenth{\o}j and Marion Leboyer and Leweke, {F Markus} and Sh{\^o}n Lewis and Phillip McGuire and Andreas Meyer-Lindenberg and Dan Rujescu and Shitij Kapur and Kahn, {Ren{\'e} S} and Sommer, {Iris E}",

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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

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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.

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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

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DO - 10.1093/schbul/sbv019

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SN - 0586-7614

VL - 41

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JO - Schizophrenia Bulletin

JF - Schizophrenia Bulletin

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ER -

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

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Keywords

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