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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004601

Enrollment

Registered

2010-12-01

Start date

2011-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obsessive Compulsive Disorder (POCD)

Interventions

12-week fluvoxiamine or paroxetine therapy. 12-week another test drug therapy in the patient group that does not satisfy CY-BOCS response criteria by 12-week fluvoxamine or paroxetine therapy. Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects with current DSM-IV-TR Obsessive Compulsive Disorder 2. Subjects who are under 18 years old more than 6 years old 3. Patients and their parents or guardian understand the study contents and give written informed consent and assent 4. Subjects are outpatients

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The effect of continuous administration of SSRI on changes of clinical indicator (CY-BOCS score)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactTakashi Okada

The University of Kyoto Hospital Department of Psychiatry

075-751-3383

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026