Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.

Although the use of placebo in clinical trials of schizophrenia patients is controversial because of medical and ethical concerns, placebo-controlled clinical trials are commonly used in the licensing of new drugs.The objective of this study was to assess the attitudes toward placebo-controlled clin...

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Main Authors: Norio Sugawara, Masamichi Ishioka, Shoko Tsuchimine, Koji Tsuruga, Yasushi Sato, Hanako Furukori, Shuhei Kudo, Tetsu Tomita, Taku Nakagami, Norio Yasui-Furukori
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2015-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC4658191?pdf=render
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author Norio Sugawara
Masamichi Ishioka
Shoko Tsuchimine
Koji Tsuruga
Yasushi Sato
Hanako Furukori
Shuhei Kudo
Tetsu Tomita
Taku Nakagami
Norio Yasui-Furukori
author_facet Norio Sugawara
Masamichi Ishioka
Shoko Tsuchimine
Koji Tsuruga
Yasushi Sato
Hanako Furukori
Shuhei Kudo
Tetsu Tomita
Taku Nakagami
Norio Yasui-Furukori
author_sort Norio Sugawara
collection DOAJ
description Although the use of placebo in clinical trials of schizophrenia patients is controversial because of medical and ethical concerns, placebo-controlled clinical trials are commonly used in the licensing of new drugs.The objective of this study was to assess the attitudes toward placebo-controlled clinical trials among patients with schizophrenia in Japan.Using a cross-sectional design, we recruited patients (n = 251) aged 47.7±13.2 (mean±SD) with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who were admitted to six psychiatric hospitals from December 2013 to March 2014. We employed a 14-item questionnaire specifically developed to survey patients' attitudes toward placebo-controlled clinical trials.The results indicated that 33% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for improvement of disease, a guarantee of hospital treatment continuation, and encouragement by family or friends were associated with the willingness to participate in such trials, whereas a belief of additional time required for medical examinations was associated with non-participation.Fewer than half of the respondents stated that they would be willing to participate in placebo-controlled clinical trials. Therefore, interpreting the results from placebo-controlled clinical trials could be negatively affected by selection bias.
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spelling doaj.art-001ee485aae1475585bbf324b05dcc152022-12-21T18:56:42ZengPublic Library of Science (PLoS)PLoS ONE1932-62032015-01-011011e014335610.1371/journal.pone.0143356Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.Norio SugawaraMasamichi IshiokaShoko TsuchimineKoji TsurugaYasushi SatoHanako FurukoriShuhei KudoTetsu TomitaTaku NakagamiNorio Yasui-FurukoriAlthough the use of placebo in clinical trials of schizophrenia patients is controversial because of medical and ethical concerns, placebo-controlled clinical trials are commonly used in the licensing of new drugs.The objective of this study was to assess the attitudes toward placebo-controlled clinical trials among patients with schizophrenia in Japan.Using a cross-sectional design, we recruited patients (n = 251) aged 47.7±13.2 (mean±SD) with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who were admitted to six psychiatric hospitals from December 2013 to March 2014. We employed a 14-item questionnaire specifically developed to survey patients' attitudes toward placebo-controlled clinical trials.The results indicated that 33% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for improvement of disease, a guarantee of hospital treatment continuation, and encouragement by family or friends were associated with the willingness to participate in such trials, whereas a belief of additional time required for medical examinations was associated with non-participation.Fewer than half of the respondents stated that they would be willing to participate in placebo-controlled clinical trials. Therefore, interpreting the results from placebo-controlled clinical trials could be negatively affected by selection bias.http://europepmc.org/articles/PMC4658191?pdf=render
spellingShingle Norio Sugawara
Masamichi Ishioka
Shoko Tsuchimine
Koji Tsuruga
Yasushi Sato
Hanako Furukori
Shuhei Kudo
Tetsu Tomita
Taku Nakagami
Norio Yasui-Furukori
Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.
PLoS ONE
title Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.
title_full Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.
title_fullStr Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.
title_full_unstemmed Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.
title_short Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.
title_sort attitudes toward placebo controlled clinical trials of patients with schizophrenia in japan
url http://europepmc.org/articles/PMC4658191?pdf=render
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