A Phase 3 study of SME3110 in Pediatric/Adolescent Subjects with Obsessive Compulsive Disorder

INTERVENTION: investigational material(s) Generic name etc : SME3110 INN of investigational material : Fluvoxamine Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material : Increasing of dose period:Duration is 6 weeks. Dose is 25 mg/day to maximum 150 mg/day, Maintained period:Duration is 4 weeks. Dose is 50 mg/day to maximum 150 mg/day, Tapering dose period:The duration of the tapering phase for each subject will depend on investigator's discretion. Maximum 4 weeks control material(s) Generic name etc : placebo INN of investigational material : Therapeutic category code : ‐‐‐ Other Dosage and Administration for Investigational material : Increasing of dose period:Duration is 6 weeks. Dose is 1 tablet to maximum 6 tablets, Maintained period:Duration is 4 weeks. Dose is 2 tablets to maximum 6 tablets, Tapering dose period:The duration of the tapering phase for each subject will depend on investigator's discretion. Maximum 4 weeks CONDITION: Pediatric/Adolescent Obsessive Compulsive Disorder PRIMARY OUTCOME: Mean change from baseline to the last post‐baseline visit in the JCY‐BOCS 10‐item total score. Compare the mean change of the JCY‐BOCS 10‐item total score between SME3110 and placebo.; Week 10 (1st phase); Mean change of the JCY‐BOCS 10‐item total score.; To Week 52 (2nd phase); Frequency of Adverse Events and Adverse Drug Reactions; To Week 10 (1st phase) and To Week 52 (2nd phase) SECONDARY OUTCOME: Stratified analysis of the change from baseline to the last postbaseline; visit in the Japanese version of the JCY‐BOCS 10‐item total score with baseline factors (experience of treatment of fluvoxamine in the past, age, gender); To Week 10 (1st phase); The change from baseline to each post‐baseline measurement in the JCY‐BOCS 10‐item total score and sub‐score; To Week 10 (1st phase); The JCY‐BOCS 10‐item total score and sub‐score; To Week 10 (1st phase); Clinical Global Impression Improvement; To Week 10 (1st phase); The proportion of subject with a 25% decrease from baseline in the JCY‐BOCS 10‐item total score; To Week 10 (1st phase); The proportion of subject with a 35% decrease from baseline in the JCY‐BOCS 10‐item total score; To Week 10 (1st phase); Change of Laboratory test result, Height, Body weight, Blood pressure and Pulse rate; To Week 10 (1st phase); Change of Laboratory test result, Height, Body weight, Blood pressure and Pulse rate and Electrocardiography; To Week 52 (2nd phase); Withdrawn syndrome includes headache, nausea, dizziness, anxiety feelings, insomnia, loss of concentration; From Week 10 to Week 14 (1st Phase)From Week 52 to Week 56 (2nd Phase) INCLUSION CRITERIA: 1. Subject has at least 16 scores in Japanese version of the JCY‐BOCS 10‐item total score and at least 5 scores in Obsession sub total score and in Compulsion sub‐total score respectively at the Screening period and Baseline. 2. Subject showed less than 25% reduction in Japanese version of the JCY‐BOCS 10‐item total score at Baseline compared to the score at the Screening period (Total score at Baseline Total score at Screening 0.75). 3. Subject has Obsessive compulsive disorder symptoms at least for 2 months prior to informed consent. 4. Body weight: >=standard weight ‐2 standard deviation based on the standard weight for each age in the School Health Statistical Survey. 5. Subjects with parent or legal guardian who have received explanation about the purpose, procedure and meaning of the study sufficiently and is willing to give written informed consent for the subject. (if possible, written informed assent will be obtained from the subject).