UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003051 |
|---|---|
| Receipt number | R000003699 |
| Scientific Title | An exploratory study for clinical benefits of the guideline on drug use in subjects with pediatric obsessive compulsive disorder |
| Date of disclosure of the study information | 2010/01/18 |
| Last modified on | 2010/01/17 20:31:32 |
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Basic information
Public title
An exploratory study for clinical benefits of the guideline on drug use in subjects with pediatric obsessive compulsive disorder
Acronym
An exploratory study for clinical benefits of the guideline on drug use in subjects with pediatric obsessive compulsive disorder
Scientific Title
An exploratory study for clinical benefits of the guideline on drug use in subjects with pediatric obsessive compulsive disorder
Scientific Title:Acronym
An exploratory study for clinical benefits of the guideline on drug use in subjects with pediatric obsessive compulsive disorder
Region
| Japan |
Condition
Condition
Pediatric Obsessive Compulsive Disorder (POCD)
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the clinical benefits of the guideline on drug use that we proposed before. We examine the safety and the efficacy of the SSRI (Fluvoxiamine or/and Paroxetine) administration for the symptoms in subjects with POCD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The effect of continuous administration of SSRI on changes of clinical indicator (CY-BOCS score)
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Continuation of 12-week fluvoxamine or paroxetine therapy in the patient group that satisfies CY-BOCS response criteria by 12-week fluvoxamine or paroxetine therapy.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key 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
Key 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
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Kuwabara |
Organization
The University of Tokyo Hospital
Division name
Department of Child Psychiatry
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo Hospital
Division name
Department of Child Psychiatry
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Department of Child Psychiatry, The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Health, Labour and Welfare Ministry
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
1. Kohnodai Hospital, International Medical Center of Japan
2. Tokyo Metropolitan Umegaoka Hospital
3. Oyamadai suku-suku clinic
4. Kyushu University Hospital
5. Kyoto University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立国際医療センター国府台病院（千葉県）、東京都立梅ヶ丘病院（東京都）、尾山台すくすくクリニック（東京都）、九州大学病院（福岡県）、京都大学医学部附属病院（京都府）、東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2009 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 17 | Day |
Last modified on
| 2010 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003699
