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Strategic use of new generation antidepressants for depression: SUN(^_^) D protocol update and statistical analysis plan

Overview of attention for article published in Trials, October 2015
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Title
Strategic use of new generation antidepressants for depression: SUN(^_^) D protocol update and statistical analysis plan
Published in
Trials, October 2015
DOI 10.1186/s13063-015-0985-6
Pubmed ID
Authors

Naohiro Yonemoto, Shiro Tanaka, Toshi A. Furukawa, Tadashi Kato, Akio Mantani, Yusuke Ogawa, Aran Tajika, Nozomi Takeshima, Yu Hayasaka, Kiyomi Shinohara, Kazuhira Miki, Masatoshi Inagaki, Shinji Shimodera, Tatsuo Akechi, Mitsuhiko Yamada, Norio Watanabe, Gordon H. Guyatt, for the SUN(^_^)D Investigators

Abstract

SUN(^_^)D, the Strategic Use of New generation antidepressants for Depression, is an assessor-blinded, parallel-group, multicenter pragmatic mega-trial to examine the optimum treatment strategy for the first- and second-line treatments for unipolar major depressive episodes. The trial has three steps and two randomizations. Step I randomization compares the minimum and the maximum dosing strategy for the first-line antidepressant. Step II randomization compares the continuation, augmentation or switching strategy for the second-line antidepressant treatment. Step III is a naturalistic continuation phase. The original protocol was published in 2011, and we hereby report its updated protocol including the statistical analysis plan. We implemented two important changes to the original protocol. One is about the required sample size, reflecting the smaller number of dropouts than had been expected. Another is in the organization of the primary and secondary outcomes in order to make the report of the main trial results as pertinent and interpretable as possible for clinical practices. Due to the complexity of the trial, we plan to report the main results in two separate reports, and this updated protocol and the statistical analysis plan have laid out respective primary and secondary outcomes and their analyses. We will convene the blind interpretation committee before the randomization code is broken. This paper presents the updated protocol and the detailed statistical analysis plan for the SUN(^_^)D trial in order to avoid reporting bias and data-driven results. ClinicalTrials.gov: NCT01109693 (registered on 21 April 2010).

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Geographical breakdown

Country Count As %
Unknown 57 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 10 18%
Student > Ph. D. Student 6 11%
Professor 6 11%
Student > Master 4 7%
Student > Bachelor 3 5%
Other 11 19%
Unknown 17 30%
Readers by discipline Count As %
Medicine and Dentistry 14 25%
Psychology 11 19%
Pharmacology, Toxicology and Pharmaceutical Science 5 9%
Nursing and Health Professions 2 4%
Computer Science 1 2%
Other 4 7%
Unknown 20 35%