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Open Access 01-12-2015 | Update

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

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

Published in: Trials | Issue 1/2015

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).

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Title: Strategic use of new generation antidepressants for depression: SUN(^_^) D protocol update and statistical analysis plan
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
Publication date: 01-12-2015
Publisher: BioMed Central
Published in: Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-015-0985-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Results

Conclusion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Results

Conclusion

Trial registration

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