NCT00353028.

Study name	NCT00353028
Methods	Trial design: randomised controlled trial; multicentre Power calculation: not stated Use of diagnostic criteria (or clear specification of inclusion criteria): yes Intervention integrity: NA Outcome measures described or validated measures used: yes Follow‐up assessment points: 8 weeks No. crossed over: not stated Funded by: Solvay Pharmaceuticals
Participants	Setting of care: not stated Recruitment: not stated Mean age: not stated Age range: 8 to 18 years Gender (F:M): NA Methods used to diagnose: the Japanese Version of the Structured Interview Guide for the Hamilton Depression Rating Scale (JSIGH‐D) 17‐item total score Diagnosis: depression or depressive state Baseline severity of depression: not stated Comorbidity intervention and control: NA Location: Japan Inclusion criteria: a minimum total score of 18 on the JSIGH‐D, weight within the standard weight ± 2 SD based on the standard weight for each age in the School Health Statistical Survey Exclusion criteria: predominant psychiatric diagnosis ‐ schizophrenia, or previously been treated with fluvoxamine maleate
Interventions	Intervention group: Drug arm 1: fluvoxamine maleate Dosage: 25 mg to 150 mg (1 to 6 tablets) Regimen: once daily Length of treatment: 8 weeks Control group: placebo Evaluations at baseline, 8 weeks
Outcomes	Depressive symptoms: time of onset of 50% decrease from baseline in the JSIGH‐D Functioning: the Clinical Global Impression scale (CGI)
Starting date
Contact information
Notes	Contacted Toshiaki Yamaguchi, trial director at Solvay Pharmaceuticals on 13 October 2011 regarding trial status, however no reply received at time of publication