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

Phase 3

• Conditions: Pediatric/Adolescent Obsessive Compulsive Disorder

• Registration Number: JPRN-jRCT2080222216
• Lead Sponsor: AbbVie GK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 36

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>Week 10 (1st phase)<br>Mean change of the JCY-BOCS 10-item total score.<br>To Week 52 (2nd phase)<br>Frequency of Adverse Events and Adverse Drug Reactions<br>To Week 10 (1st phase) and To Week 52 (2nd phase)