Pediatric/Adolescent Obsessive Compulsive Disorder
Conditions
Interventions
investigational material(s)
Generic name etc : SME3110
INN of investigational material : Fluvoxamine
Therapeutic category code : 117 Psychotropic agents
Dosage and Administration for Investigational m
Sponsors
AbbVie GK
Meiji Seika Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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).
Exclusion criteria
Exclusion criteria: 1. Subject has only trichotillomania or nail-biting as his/her compulsive symptoms. 2. Subject has Tourette's disorder. However, the simple motor tic is not excluded. 3. Subject is diagnosed as the following psychiatric disorders. Schizophrenia and other psychotic disorders, Depressive disorders, Bipolar disorders, Mental retardation, Eating disorders, Attention-deficit/hyperactivity disorder, Obsessive compulsive personality disorder and Other patients with clinical neurological disorder. 4. Subject who diagnose Major Depressive Disorder by The Mini-International Neuropsychiatric Interview for Children and Adolescents (A) at the Screening period. 5. Subject has been treated with fluvoxamine within 2 months prior to informed consent. Except for the those who the fluvoxamine dose is not stable fixed and the administration period of fluvoxamine is within 6 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Outcome results
None listed