An exploratory study for clinical benefits of the guideline on drug use in subjects with pediatric obsessive compulsive disorder

Not Applicable

• Conditions: Pediatric Obsessive Compulsive Disorder (POCD)

• Registration Number: JPRN-UMIN000004601
• Lead Sponsor: Department of Child Psychiatry, The University of Tokyo Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects with severe brain organic disease 2. Subjects with current DSM-IV-TR schizophrenia and other psychotic disorders or bipolar disorder 3. Subjects with mental retardation (IQ < 70) 4. Subjects who are administrated neurotropics except the test drugs from 7 days prior to the trial start 5. Subjects who are hospitalized 6. Subjects who are receiving structured cognitive behavioral therapy for OCD at the trial start 7. Subjects with current or past history of convulsion 8. Subjects with current or past history of serious suicidal ideation or attempt 9. Subjects with current or past history allergy for the test drugs 10. Pregnant or lactating women 11. Patient whom examination doctor judged improper as a trial subject

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of continuous administration of SSRI on changes of clinical indicator (CY-BOCS score)

Secondary Outcome Measures

Name	Time	Method
1. Analysis of the primary endpoint which coordinated stratification by background factors 2. Variation with time of CY-BOCS score 3. Change of total and sub CY-BOCS score 4. Other clinical indicator (Obsessive Compulsive symptoms (NIMH-OCS, self-insight, DY-BOCS), social function (CGAS), quality of life (PedsQL, QOL26), clinical global impression (CGI), comorbidity (WISC-III, CBCL, M.I.N.I. KID, YGTSS, IRS, DSRS, STAIC), biological marker) 5. Variation of CY-BOCS score which coordinated by CY-BOCS score before treatment 6. Hierarchy analysis in variation of CY-BOCS score 7. Analysis of safety assessment index 8. Adverse event 9. Laboratory test 10. Electrocardiogram