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.
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.


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov identifier: NCT01109693.
Department of Neuropsychiatry, Kochi Medical School, Nankokushi, Kochi, Japan.
Shinji
S
Shimodera
Tadashi
T
Kato
Hirotoshi
H
Sato
Kazuhira
K
Miki
Yoshihiro
Y
Shinagawa
Masaki
M
Kondo
Hirokazu
H
Fujita
Ippei
I
Morokuma
Yoshio
Y
Ikeda
Tatsuo
T
Akechi
Norio
N
Watanabe
Mitsuhiko
M
Yamada
Masatoshi
M
Inagaki
Naohiro
N
Yonemoto
Toshi A
TA
Furukawa
D018759:Adrenergic Uptake Inhibitors / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000929:Antidepressive Agents, Tricyclic / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D057915:Drug Substitution; D004359:Drug Therapy, Combination; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007258:Informed Consent; D007564:Japan; D008297:Male; D055118:Medication Adherence; D008803:Mianserin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D000078785:Mirtazapine; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D020280:Sertraline / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D018759:Adrenergic Uptake Inhibitors; D000929:Antidepressive Agents, Tricyclic; D008803:Mianserin; D000078785:Mirtazapine; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline