Changing the Antipsychotic in Early Nonimprovers to Amisulpride or Olanzapine: Randomized, Double-Blind Trial in Patients With Schizophrenia.


Journal

Schizophrenia bulletin
ISSN: 1745-1701
Titre abrégé: Schizophr Bull
Pays: United States
ID NLM: 0236760

Informations de publication

Date de publication:
18 11 2022
Historique:
pubmed: 21 7 2022
medline: 22 11 2022
entrez: 20 7 2022
Statut: ppublish

Résumé

Meta-analyses have shown that the majority of patients with schizophrenia who have not improved after 2 weeks of treatment with an antipsychotic drug are unlikely to fully respond later. We hypothesized that switching to another antipsychotic with a different receptor binding profile is an effective strategy in such a situation. In total, 327 inpatients with an acute exacerbation of schizophrenia were randomized to double-blind treatment with either olanzapine (5-20 mg/day) or amisulpride (200-800 mg/day). Those patients who had not reached at least 25% Positive-and-Negative-Syndrome-Scale (PANSS) total score reduction from baseline after 2 weeks (the "non-improvers") were rerandomized double-blind to either staying on the same compound ("stayers") or to switching to the other antipsychotic ("switchers") for another 6 weeks. The primary outcome was the difference in the number of patients in symptomatic remission between the combined "switchers" and the "stayers" after 8 weeks of treatment, analyzed by logistic regression. A total of 142 nonimprovers were rerandomized at week two. 25 (45.5 %) of the 'stayers' compared to 41 (68.3 %) of the "switchers" reached remission at endpoint (p = .006). Differences in secondary efficacy outcomes were not significant, except for the PANSS negative subscore and the Clinical-Global-Impression-Scale. "Switchers" and "stayers" did not differ in safety outcomes. Switching "non-improvers" from amisulpride to olanzapine or vice-versa increased remission rates and was safe. The superiority in the primary outcome was, however, not paralleled by significant differences in most secondary efficacy outcomes and the effect was only apparent at the last visit making replications of longer duration necessary.

Sections du résumé

BACKGROUND AND HYPOTHESIS
Meta-analyses have shown that the majority of patients with schizophrenia who have not improved after 2 weeks of treatment with an antipsychotic drug are unlikely to fully respond later. We hypothesized that switching to another antipsychotic with a different receptor binding profile is an effective strategy in such a situation.
STUDY DESIGN
In total, 327 inpatients with an acute exacerbation of schizophrenia were randomized to double-blind treatment with either olanzapine (5-20 mg/day) or amisulpride (200-800 mg/day). Those patients who had not reached at least 25% Positive-and-Negative-Syndrome-Scale (PANSS) total score reduction from baseline after 2 weeks (the "non-improvers") were rerandomized double-blind to either staying on the same compound ("stayers") or to switching to the other antipsychotic ("switchers") for another 6 weeks. The primary outcome was the difference in the number of patients in symptomatic remission between the combined "switchers" and the "stayers" after 8 weeks of treatment, analyzed by logistic regression.
STUDY RESULTS
A total of 142 nonimprovers were rerandomized at week two. 25 (45.5 %) of the 'stayers' compared to 41 (68.3 %) of the "switchers" reached remission at endpoint (p = .006). Differences in secondary efficacy outcomes were not significant, except for the PANSS negative subscore and the Clinical-Global-Impression-Scale. "Switchers" and "stayers" did not differ in safety outcomes.
CONCLUSIONS
Switching "non-improvers" from amisulpride to olanzapine or vice-versa increased remission rates and was safe. The superiority in the primary outcome was, however, not paralleled by significant differences in most secondary efficacy outcomes and the effect was only apparent at the last visit making replications of longer duration necessary.

Identifiants

pubmed: 35857811
pii: 6647446
doi: 10.1093/schbul/sbac068
pmc: PMC9673269
doi:

Substances chimiques

Antipsychotic Agents 0
Olanzapine N7U69T4SZR
Amisulpride 8110R61I4U
Benzodiazepines 12794-10-4

Types de publication

Randomized Controlled Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1273-1283

Informations de copyright

© The Author(s) 2022. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

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Auteurs

Stephan Heres (S)

Klinik Nord des Isar-Amper-Klinikums München Ost Kölner Platz 1, Haus 7 80804 Munich, Germany.
Department of Psychiatry and Psychotherapy, Technical University of Munich, School of Medicine, Munich, Germany.

Joachim Cordes (J)

Department of Psychiatry and Psychotherapy, LVR-Clinic Düsseldorf, Medical Faculty, Heinrich-Heine-University, Duesseldorf NW, Germany.
Department of Psychiatry and Psychotherapy, Kaiserswerther Diakonie, Florence Nightingale Hospital, Düsseldorf NW, Germany.

Sandra Feyerabend (S)

Department of Psychiatry and Psychotherapy, LVR-Clinic Düsseldorf, Medical Faculty, Heinrich-Heine-University, Duesseldorf NW, Germany.
Department of Psychiatry and Psychotherapy, Kaiserswerther Diakonie, Florence Nightingale Hospital, Düsseldorf NW, Germany.

Christian Schmidt-Kraepelin (C)

Department of Psychiatry and Psychotherapy, LVR-Clinic Düsseldorf, Medical Faculty, Heinrich-Heine-University, Duesseldorf NW, Germany.
Department of Psychiatry and Psychotherapy, Kaiserswerther Diakonie, Florence Nightingale Hospital, Düsseldorf NW, Germany.

Richard Musil (R)

Department of Psychiatry and Psychotherapy, Ludwig Maximilians University of Munich, Munich, Germany.

Michael Riedel (M)

Department of Psychiatry and Psychotherapy, Ludwig Maximilians University of Munich, Munich, Germany.
Marion von Tessin Memory-Zentrum GmbH, Munich BY, Germany.

Ilja Spellmann (I)

Department of Psychiatry and Psychotherapy, Ludwig Maximilians University of Munich, Munich, Germany.
Klinikum Stuttgart, Zentrum für Seelische Gesundheit, Stuttgart BW, Germany.

Berthold Langguth (B)

Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg BY, Germany.

Michael Landgrebe (M)

Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg BY, Germany.
Department of Psychiatry and Psychotherapy, kbo Lech-Mangfall-Hospital Agatharied, St.-Agatha-Str. 1a, 83734 Hausham BY, Germany.

Elmar Fran (E)

Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg BY, Germany.

Camelia Petcu C (C)

Psychiatry Department, University of Medicine and Pharmacy "Carol Davila" Bucharest, "Prof. Dr. Alexandru Obregia" Psychiatric Hospital, Berceni Str 10-12, Bucharest, Romania.

Eric Hahn (E)

Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin Campus Benjamin Franklin, Berlin, Germany.

Tam M T Ta (TMT)

Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin Campus Benjamin Franklin, Berlin, Germany.

Valentin Matei (V)

Psychiatry Department, University of Medicine and Pharmacy "Carol Davila" Bucharest, "Prof. Dr. Alexandru Obregia" Psychiatric Hospital, Berceni Str 10-12, Bucharest, Romania.

Liana Dehelean (L)

Department of Neurosciences-Psychiatry, "Victor Babes" University of Medicine and Pharmacy, 300041 Timisoara TS, Romania.
Centre for Cognitive Research in Neuropsychiatric Pathology, "Victor Babes" University of Medicine and Pharmacy, 300041 Timisoara TS, Romania.
Center for Translational Research, and Systems Medicine, "Victor Babes" University of Medicine and Pharmacy, 300041 Timisoara TS, Romania.
Center for Studies in Preventive Medicine, "Victor Babes" University of Medicine and Pharmacy, 300041 Timisoara TS, Romania.

Ion Papava (I)

Department of Neurosciences-Psychiatry, "Victor Babes" University of Medicine and Pharmacy, 300041 Timisoara TS, Romania.
Centre for Cognitive Research in Neuropsychiatric Pathology, "Victor Babes" University of Medicine and Pharmacy, 300041 Timisoara TS, Romania.

F Markus Leweke (FM)

Brain and Mind Centre, The University of Sydney, 94 Mallet St, Camperdown NSW 2050, Sydney, Australia.
Central Institute of Mental Health, Heidelberg University I5, 68159 Mannheim BW, Germany.

Till van der List (T)

Central Institute of Mental Health, Heidelberg University I5, 68159 Mannheim BW, Germany.
Practise for Psychiatry and Psychotherapie Nowackanlage 15, 76137 Karlsruhe BW, Germany.

Simona C Tamasan (SC)

Liaison Psychiatry, "Pius Branzeu" County Emergency Hospital, Timisoara TS, Romania.

Fabian U Lang (FU)

Department of Psychiatry II, Ulm University, Ulm BW, Germany.

Dieter Naber (D)

Department of Psychiatry and Psychotherapy, University of Hamburg, Hamburg, Germany.

Stephan Ruhrmann (S)

Department of Psychiatry and Psychotherapy, Faculty of Medicine and University Hospital, University of Cologne, Cologne NW, Germany.

Claus Wolff-Menzler (C)

Klinik für Psychiatrie und Psychotherapie Universitätsmedizin Göttingen, Göttingen, Germany.

Georg Juckel (G)

Department of Psychiatry, LWL University Hospital, Psychotherapy and Preventive Medicine Ruhr University, Bochum, Germany.

Maria Ladea (M)

DMU IMPACT (Departement Medico-Universitaire de Psychiatrie et d'Addictologie) Groupe Hospitalier Henri MONDOR, Créteil, France.

Cristinel Stefanescu (C)

University of Medicine and Farmacy Grigore T. Popa in Iasi, Iasi, Romania.

Marion Lautenschlager (M)

ZfP Südwürttemberg, Bad Schussenried, Germany.
Charité University Medicine, Campus Mitte, Berlin BE, Germany.

Michael Bauer (M)

Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universitaet Dresden, Dresden, Germany.

Daisy Zamora (D)

Department of Psychiatry and Psychotherapy, Technical University of Munich, School of Medicine, Munich, Germany.
Department of Psychiatry, UNC School of Medicine, 321 S Columbia St, Chapel Hill, NC 27599, USA.

Mark Horowitz (M)

Department of Psychiatry, University of Illinois, Chicago, IL, USA.

John M Davis (JM)

Department of Psychiatry, University of Illinois, Chicago, IL, USA.

Stefan Leucht (S)

Department of Psychiatry and Psychotherapy, Technical University of Munich, School of Medicine, Munich, Germany.

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