Contribution to external validity of randomized controlled trials by comparing between a mega-trial and observational studies.

2015 Fiscal Year Final Research Report

• Project/Area Number: 26860416
• Research Category: Grant-in-Aid for Young Scientists (B)
• Allocation Type: Multi-year Fund
• Research Field: Epidemiology and preventive medicine
• Research Institution: Kyoto University
• Principal Investigator: Ogawa Yusuke 京都大学, 医学(系)研究科(研究院), 助教 (50535573)
• Project Period (FY): 2014-04-01 – 2016-03-31
• Keywords: 臨床疫学 / 抗うつ薬

Outline of Final Research Achievements

The objective of this study was to examine whether the results of effectiveness randomized controlled trials (RCTs) have external validity by comparing the results of the mega-trial which examines the optimum treatment strategy for unipolar major depressive episodes and previous observational studies of antidepressants for treatment of depression. We conducted systematic review of observational studies that reported manic switch in patients with depression treated with antidepressants. Similar results were observed between this mega-trial and observational studies. It was suggested that RCT designed to raise external validity could preserve generalizability.

Free Research Field

臨床疫学