A Phase 3 study of SME3110 (fluvoxamine maleate) in Pediatric/Adolescent Subjects with Obsessive Compulsive Disorder

AbbVie GK0 个研究点目标入组 36 人开始时间: 2013年9月6日最近更新: 2023年10月17日

适应症

试验速览

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•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).

•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.

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