title: Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  The objective of this study was to assess the attitudes toward placebo-controlled clinical trials among patients with schizophrenia in Japan.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Aomori Prefectural Center for Mental Health and Welfare, Aomori, Japan.|Department of Neuropsychiatry, Hirosaki University School of Medicine, Hirosaki, Japan.
authors.forename: Norio
authors.initials: N
authors.lastname: Sugawara
authors.affiliation: Department of Psychiatry, Hirosaki-Aiseikai Hospital, Hirosaki, Japan.
authors.forename: Masamichi
authors.initials: M
authors.lastname: Ishioka
authors.affiliation: Department of Neuropsychiatry, Hirosaki University School of Medicine, Hirosaki, Japan.
authors.forename: Shoko
authors.initials: S
authors.lastname: Tsuchimine
authors.affiliation: Department of Neuropsychiatry, Hirosaki University School of Medicine, Hirosaki, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Tsuruga
authors.affiliation: Department of Psychiatry, Seihoku-Chuoh Hospital, Goshogawara, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Sato
authors.affiliation: Department of Psychiatry, Kuroishi-Akebono Hospital, Kuroishi, Japan.
authors.forename: Hanako
authors.initials: H
authors.lastname: Furukori
authors.affiliation: Department of Psychiatry, Hirosaki-Aiseikai Hospital, Hirosaki, Japan.
authors.forename: Shuhei
authors.initials: S
authors.lastname: Kudo
authors.affiliation: Department of Neuropsychiatry, Odate Municipal General Hospital, Odate, Japan.
authors.forename: Tetsu
authors.initials: T
authors.lastname: Tomita
authors.affiliation: Department of Neuropsychiatry, Odate Municipal General Hospital, Odate, Japan.
authors.forename: Taku
authors.initials: T
authors.lastname: Nakagami
authors.affiliation: Department of Neuropsychiatry, Hirosaki University School of Medicine, Hirosaki, Japan.
authors.forename: Norio
authors.initials: N
authors.lastname: Yasui-Furukori
mesh_terms: D000328:Adult; D001290:Attitude; D018849:Controlled Clinical Trials as Topic; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011618:Psychotic Disorders / Q000523:psychology / Q000628:therapy; D012565:Schizophrenic Psychology; D012959:Socioeconomic Factors