The first 100 patients in the SUN(^_^)D trial (strategic use of new generation antidepressants for depression): examination of feasibility and adherence during the pilot phase

Shinji Shimodera, Tadashi Kato, Hirotoshi Sato, Kazuhira Miki, Yoshihiro Shinagawa, Masaki Kondo, Hirokazu Fujita, Ippei Morokuma, Yoshio Ikeda, Tatsuo Akechi, Norio Watanabe, Mitsuhiko Yamada, Masatoshi Inagaki, Naohiro Yonemoto, Toshi A Furukawa, SUN(^_^)D Investigators, Tatsuo Akechi, Norio Watanabe, Yumi Nakano, Masaki Kondo, Tadashi Kato, Yoshihiro Shinagawa, Yoshio Ikeda, Yoshiyuki Itakura, Kazuhira Miki, Shinji Shimodera, Hirokazu Fujita, Ippei Morokuma, Mikako Fuji, Chisato Ichikawa, Ryosuke Fujito, Takashi Ito, Hirotoshi Sato, Mitsuhiko Yamada, Masatoshi Inagaki, Naohiro Yonemoto, Toshi A Furukawa, Shinji Shimodera, Tadashi Kato, Hirotoshi Sato, Kazuhira Miki, Yoshihiro Shinagawa, Masaki Kondo, Hirokazu Fujita, Ippei Morokuma, Yoshio Ikeda, Tatsuo Akechi, Norio Watanabe, Mitsuhiko Yamada, Masatoshi Inagaki, Naohiro Yonemoto, Toshi A Furukawa, SUN(^_^)D Investigators, Tatsuo Akechi, Norio Watanabe, Yumi Nakano, Masaki Kondo, Tadashi Kato, Yoshihiro Shinagawa, Yoshio Ikeda, Yoshiyuki Itakura, Kazuhira Miki, Shinji Shimodera, Hirokazu Fujita, Ippei Morokuma, Mikako Fuji, Chisato Ichikawa, Ryosuke Fujito, Takashi Ito, Hirotoshi Sato, Mitsuhiko Yamada, Masatoshi Inagaki, Naohiro Yonemoto, Toshi A Furukawa

Abstract

Background: Initial glitches and unexpected inconsistencies are unavoidable in the early stage of a large, multi-centre trial. Adaptive modifications of the trial's protocol and operational procedures to ensure its smooth running are therefore imperative. We started a large pragmatic, multi-centre, assessor-blinded, 25-week trial to investigate the optimal first- and second-line treatments for untreated episodes of nonpsychotic major depression in 2010 [Strategic Use of New generation antidepressants for Depression, abbreviated SUN(^_^)D] and would like to herein report an examination of the trial's feasibility and adherence among the first 100 participants.

Methods: We examined the participants' characteristics, the treatments that were allocated and received during each step of the trial, and the quality of the outcome assessments among the first 100 patients enrolled in the SUN(^_^)D trial.

Results: Of the 2,743 first-visit patients who visited the two collaborating centres between December 2010 and July 2011, 382 were judged as potentially eligible, and 100 of these patients provided written informed consent. These patients represented the whole spectrum of mild to very severe depression. Of the 93 patients who had reached Week 3 of the study by the end of July 2011, one withdrew consent for both the treatment and the assessment, and eight withdrew consent for the treatment only. Altogether, the primary outcomes were successfully assessed in 90 (96.8%) of the patients at Week 3. Of the 72 patients who had reached Week 9, three withdrew consent for the treatment, but 70 were successfully interviewed (97.2%). Of the 32 patients who had reached Week 25, 29 (90.5%) were successfully followed up. The inter-rater reliability of the assessments of the primary outcomes was nearly perfect and their successful blinding was confirmed. Minor modifications and clarifications to the protocol were deemed necessary.

Discussion: Given the satisfactory feasibility and adherence to the study protocol and the minor modifications that were necessary, we conclude that the data obtained from the first 100 patients can be safely included in the main study. We now intend to accelerate the study by recruiting more collaborating centres and clinics/hospitals.

Trial registration: ClinicalTrials.gov identifier: NCT01109693.

Figures

Figure 1
Figure 1
Flow diagram of the trial.
Figure 2
Figure 2
Flowchart of the participants as of the end of July 2011.
Figure 3
Figure 3
Monthly recruitment of the participants.
Figure 4
Figure 4
Average course of depression severity of the entire cohort.

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