@article{a91a3097ec4f42408a12c7a9ec74931c,
title = "Placebo effects in adult and adolescent patients with schizophrenia: combined analysis of nine RCTs",
abstract = "Objective: To examine characteristics of placebo responders and seek optimal criteria of early improvement with placebo for predicting subsequent placebo response in patients with schizophrenia. Method: Data of 672 patients with schizophrenia randomized to placebo in nine double-blind antipsychotic trials were analyzed. Multiple logistic regression analyses were conducted to examine associations between placebo response at week 6 (i.e., a ≥ 25% reduction in the Positive and Negative Syndrome Scale [PANSS] score) and gender, age, study locations, baseline PANSS total or Marder 5-Factor scores, and per cent PANSS score reduction at week 1. Predictive power of improvement at week 1 for subsequent response was investigated; sensitivity and specificity of incremental 5% cutoff points between 5% and 25% reduction in the PANSS total score at week 1 were calculated. Results: Per cent PANSS total score reduction at week 1 and lower PANSS Marder disorganized thought scores at baseline were significantly associated with subsequent placebo response. A 10% reduction in a per-protocol analysis or a 15% reduction in last-observation-carried-forward analysis in the PANSS total score at week 1 showed the highest predictive power. Conclusion: These findings are informative to identify potential placebo responders at the earliest opportunity for optimal trial design for schizophrenia.",
keywords = "antipsychotic agents, placebo effect, placebos, schizophrenia",
author = "K. Kubo and Fleischhacker, {W. W.} and T. Suzuki and N. Yasui-Furukori and M. Mimura and H. Uchida",
note = "Funding Information: This work was supported by AMED under grant number JP18dm0107125 (MM and HU). This funding source had no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication. This study, carried out under YODA Project #2017-1676, used data obtained from the Yale University Open Data Access Project, which has an agreement with JANSSEN RESEARCH & DEVELOPMENT, L.L.C. The interpretation and reporting of research using this data are solely the responsibility of the authors and do not necessarily represent the official views of the Yale University Open Data Access Project or JANSSEN RESEARCH & DEVELOPMENT, L.L.C. The authors appreciate Larry Alphs, M.D., Ph.D., for his guidance regarding Yoda project and Ms. Aki Endo and Ms. Ai Gounaridis for their administrative support. Funding Information: This work was supported by AMED under grant number JP18dm0107125 (MM and HU). This funding source had no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication. This study, carried out under YODA Project #2017-1676, used data obtained from the Yale University Open Data Access Project, which has an agreement with JANSSEN RESEARCH & DEVELOPMENT, L.L.C.. The interpretation and reporting of research using this data are solely the responsibility of the authors and do not necessarily represent the official views of the Yale University Open Data Access Project or JANSSEN RESEARCH & DEVELOPMENT, L.L.C. The authors appreciate Larry Alphs, M.D., Ph.D., for his guidance regarding Yoda project and Ms. Aki Endo and Ms. Ai Gounaridis for their administrative support. Funding Information: Pharmaceutical, Wiley Japan, and Yoshitomi Yakuhin within the past three years. Speaker{\textquoteright}s fees from Sumitomo Dainippon Pharma, Eli Lilly, Elsevier Japan, Janssen. Dr. Yasui-Furukori has received speaker{\textquoteright}s fees from Mochida Pharmaceutical, Sumitomo Dainippon Pharma, and MSD within the past three years. Dr. Mimura has received grants and/or speaker{\textquoteright}s honoraria from Asahi Kasei Pharma, Astellas Pharmaceutical, Dai-ichi Sankyo, Sumitomo Dainippon Pharma, Eisai, Eli Lilly, Fuji Film RI Pharma, Janssen Pharmaceutical, Kracie, Meiji-Seika Pharma, Mochida Pharmaceutical, MSD, Novartis Pharma, Ono Yakuhin, Otsuka Pharmaceutical, Pfizer, Shio-nogi, Takeda Yakuhin, Tanabe Mitsubishi Pharma, and Yoshitomi Yakuhin within the past three years. Dr. Uchida has received grants from Eisai, Otsuka Pharmaceutical, Sumitomo Dainippon Pharma, Mochida Pharmaceutical, Meiji-Seika Pharmaceutical, and Novartis; speaker{\textquoteright}s honoraria from Otsuka Pharmaceutical, Eli Lilly, Shionogi, Pfizer, Yoshitomi Yakuhin, Sumitomo Dainippon Pharma, Meiji-Seika Pharma, MSD, and Janssen Pharmaceutical; and advisory panel payments from Sumitomo Dainippon Pharma within the past three years. Publisher Copyright: {\textcopyright} 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd",
year = "2019",
month = feb,
day = "1",
doi = "10.1111/acps.12960",
language = "English",
volume = "139",
pages = "108--116",
journal = "Acta Psychiatrica Scandinavica",
issn = "0001-690X",
publisher = "Wiley-Blackwell",
number = "2",
}