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Title: Strategic use of new generation antidepressants for depression: SUN(^_^) D protocol update and statistical analysis plan
Authors: Yonemoto, Naohiro
Tanaka, Shiro  kyouindb  KAKEN_id  orcid https://orcid.org/0000-0001-6817-5235 (unconfirmed)
Furukawa, Toshi A.
Kato, Tadashi
Mantani, Akio
Ogawa, Yusuke  kyouindb  KAKEN_id
Tajika, Aran  kyouindb  KAKEN_id
Takeshima, Nozomi
Hayasaka, Yu
Shinohara, Kiyomi
Miki, Kazuhira
Inagaki, Masatoshi
Shimodera, Shinji
Akechi, Tatsuo
Yamada, Mitsuhiko
Watanabe, Norio
Guyatt, Gordon H.
Author's alias: 田中, 司朗
古川, 壽亮
小川, 雄右
Issue Date: 14-Oct-2015
Publisher: BioMed Central Ltd.
Journal title: Trials
Volume: 16
Thesis number: 459
Abstract: Background: 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. Results: 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. Conclusion: 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. Trial registration: ClinicalTrials.gov: NCT01109693(registered on 21 April 2010).
Rights: © 2015 Yonemoto et al. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
URI: http://hdl.handle.net/2433/212503
DOI(Published Version): 10.1186/s13063-015-0985-6
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