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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003051
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Child Psychiatry, The University of Tokyo Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003699

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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