Examination of research design for appropriate effect estimation

• Project/Area Number: 16K09033
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Epidemiology and preventive medicine
• Research Institution: Kyoto University
• Principal Investigator: Ogawa Yusuke 京都大学, 医学研究科, 特定講師 (50535573)
• Co-Investigator(Kenkyū-buntansha): 古川 壽亮 京都大学, 医学研究科, 教授 (90275123)
• Project Period (FY): 2016-04-01 – 2019-03-31
• Project Status: Completed (Fiscal Year 2018)
• Budget Amount: ¥2,470,000 (Direct Cost: ¥1,900,000、Indirect Cost: ¥570,000); Fiscal Year 2018: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000); Fiscal Year 2017: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000); Fiscal Year 2016: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
• Keywords: 臨床疫学 / ランダム化比較試験 / 研究デザイン / 抗うつ剤 / うつ病 / メタ疫学研究

Outline of Final Research Achievements

We included randomized-controlled trials (RCTs) that 18 antidepressants compared with placebo for the treatment of major depressive disorder in adults. We calculated the ratio of odds ratios (RORs) of antideepressant response over placebo in two-armed versus three or more-armed RCTs for each drug, and then synthesized RORs across all the included drugs. The difference of effect size between two-armed and three or more-armed RCTs were found to be much smaller than those reported in the previous studies and were not significant.

Academic Significance and Societal Importance of the Research Achievements

過去の研究では2群比較試験では3群比較試験に比べ、効果サイズが大きくなることが指摘されていた。しかし、先行研究の問題点を改善した上で実施した今回の研究によりこのことは否定された。本研究の結果は、今後抗うつ剤のランダム化比較試験を計画、解釈する際に重要な情報となると考えられる。

Research Products

• [Int'l Joint Research] University of Oxford/University of Bristol(英国)
• [Int'l Joint Research] Stanford University/Oregon Health & Science University(米国)
• [Int'l Joint Research] Paris Descartes University(フランス)
• [Int'l Joint Research] Technische Universitat Munchen(ドイツ)
• [Int'l Joint Research] University of Bern(スイス)
• [Int'l Joint Research]
• [Int'l Joint Research] University of Oxford/University of Bristol(英国)
• [Int'l Joint Research] Technische Universitat Munchen(ドイツ)
• [Int'l Joint Research] University of Bern(スイス)
• [Int'l Joint Research] University of Ioannia(ギリシャ)
• [Int'l Joint Research] Paris Descartes University/Sorbonne Paris Cite Research Center(フランス)
• [Int'l Joint Research]
• [Int'l Joint Research] University of Oxford(英国)
• [Int'l Joint Research] Technische Universitat Munchen(ドイツ)
• [Int'l Joint Research] University of Bern(スイス)
• [Int'l Joint Research] University of Ioannina(ギリシャ)
• [Journal Article] Comparative efficacy and acceptability of first- and second-generation antidepressants in the acute treatment of major depressive disorder: A network meta-analysis. (2018)
  • Author(s): Cipriani A, Furukawa TA, Salanti G, Chaimani A, Atkinson LZ, Ogawa Y, Leucht S, Ruhe HG, Turner EH, Higgins JP, Egger M, Takeshima N, Hayasaka Y, Imai H, Shinohara K, Tajika A, Ioannidis JP & Geddes JR
  • Journal Title: Lancet Volume: epub Issue: 10128 Pages: 1-8
  • DOI: 10.1016/s0140-6736(17)32802-7
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Impact of placebo arms on outcomes in antidepressant trials: systematic review and meta-regression analysis (2018)
  • Author(s): Salanti Georgia、Chaimani Anna、Furukawa Toshi A、Higgins Julian P T、Ogawa Yusuke、Cipriani Andrea、Egger Matthias
  • Journal Title: International Journal of Epidemiology Volume: 47 Issue: 5 Pages: 1454-1464
  • DOI: 10.1093/ije/dyy076
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Efficacy of antidepressants over placebo is similar in two-armed versus three-armed or more-armed randomized placebo-controlled trials (2018)
  • Author(s): Ogawa Yusuke, Furukawa Toshi A., Takeshima Nozomi, Hayasaka Yu, Atkinson Lauren Z., Tanaka Shiro, Cipriani Andrea, Salanti Georgia
  • Journal Title: International Clinical Psychopharmacology Volume: 33 Issue: 2 Pages: 66-72
  • DOI: 10.1097/yic.0000000000000201
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] Is placebo response in antidepressant trials rising or not? A reanalysis of datasets to conclude this long-lasting controversy (2018)
  • Author(s): Furukawa Toshi A, Cipriani Andrea, Leucht Stefan, Atkinson Lauren Z, Ogawa Yusuke, Takeshima Nozomi, Hayasaka Yu, Chaimani Anna, Salanti Georgia
  • Journal Title: Evidence Based Mental Health Volume: 21 Issue: 1 Pages: 1-3
  • DOI: 10.1136/eb-2017-102827
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] Placebo response rates in antidepressant trials: a systematic review of published and unpublished double-blind randomised controlled studies. (2016)
  • Author(s): Furukawa TA, Cipriani A, Atkinson LZ, Leucht S, Ogawa Y, Takeshima N, Hayasaka Y, Chaimani A, Salanti G.
  • Journal Title: Lancet Psychiatry Volume: 3 Issue: 11 Pages: 1059-1066
  • DOI: 10.1016/s2215-0366(16)30307-8
  • Peer Reviewed / Int'l Joint Research