The SWITCH study: rationale and design of the trial
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Many patients do not respond to the first antipsychotic drug prescribed, but require multiple trials with different drugs before response is achieved. Current treatment guidelines vary substantially in their recommendations as to how long clinicians should wait before an antipsychotic treatment attempt should be considered as failed and the compound switched. It has, however, recently been shown that poor early response to an antipsychotic is associated with continuous poor later response in the course of the same treatment attempt. This finding suggests that patients who do experience poor early response might benefit from a switch in antipsychotic medication as early as 2 weeks after treatment initiation. In the SWITCH trial, 350 patients suffering from an acute episode of schizophrenia are randomly assigned to double-blind treatment with either olanzapine or amisulpride. The primary endpoint is symptomatic remission at week 8. Patients not experiencing at least minor response after 2 weeks are randomized again to either staying on the initially assigned drug or being switched to the alternative compound for another 6 weeks. In case early switching proves superior to maintaining treatment, time wasted for unsuccessful treatment attempts could be minimized, patients’ outcomes improved, duration of hospital stays reduced, and thus overall treatment expenses saved. The current report will present the methods of the trial, focusing on various specific features which could be adopted by future studies.
KeywordsAntipsychotic Response Switch Response prediction Treatment duration
The authors gratefully acknowledge the support from the German Ministerium fuer Bildung und Forschung (BMBF) and the project management by the Deutsche Luft- und Raumfahrt Organisation (DLR).
The study conduct is supported by a grant from the “Bundesministerium fuer Bildung und Forschung” (BMBF), a German governmental ministry (Grant code 01KG0910). As sponsor functions the Technische Universitaet Muenchen, represented by the Klinikum rechts der Isar Muenchen. Eli Lilly provides the olanzapine medication for the trial, but has no influence on the protocol, data analysis, publication, or other aspects of the trial.
Study recruitment has started in January 2010, and first results can be expected at the end of 2015.
Compliance with ethical standards
Conflict of interest
Dr. Heres has received lecture honoraria from Janssen-Cilag, Sanofi-Aventis, Bristol-Myers-Squibb, Eli Lilly, and Johnson & Johnson. Dr. Heres acts as consultant and/or participates in board meetings of Janssen-Cilag, Eli Lilly, Roche, Lundbeck, and Johnson & Johnson. Dr. Heres has accepted travel or hospitality payment from Janssen-Cilag, Sanofi-Aventis, Johnson & Johnson, Pfizer, Bristol-Myers Squibb, AstraZeneca, Lundbeck, Novartis, and Eli Lilly. Dr. Heres participated in clinical trials sponsored or supported by Eli Lilly, Janssen-Cilag, Johnson & Johnson, Bristol-Myers Squibb, AstraZeneca, Lundbeck, Novartis, Servier, Pierre Fabre, Pfizer, Roche, Shire, and Merck. Prof. Stefan Leucht has received lecture honoraria and functioned as advisory board member or consultant from/for Janssen-Cilag, Sanofi-Aventis, Bristol-Myers Squibb, Eli Lilly and company, GlaxoSmithKline, H. Lundbeck A/S, Pfizer Inc., Sanofi-Aventis, and Johnson & Johnson. He received lecture honoraria from AstraZeneca and EssexPharma and research grants from Eli Lilly and Sanofi-Aventis.
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