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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006399
Receipt No. R000007594
Scientific Title Clinical Features of Obsessive-Compulsive Disorder with Pervasive Developmental Disorder
Date of disclosure of the study information 2011/11/01
Last modified on 2012/10/25

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Basic information
Public title Clinical Features of Obsessive-Compulsive Disorder with Pervasive Developmental Disorder
Acronym Clinical Features of Obsessive-Compulsive Disorder with Pervasive Developmental Disorder
Scientific Title Clinical Features of Obsessive-Compulsive Disorder with Pervasive Developmental Disorder
Scientific Title:Acronym Clinical Features of Obsessive-Compulsive Disorder with Pervasive Developmental Disorder
Region
Japan

Condition
Condition Obsessive-Compulsive Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to investigate the clinical features of obsessive-compulsive disorder with pervasive developmental disorder
Basic objectives2 Others
Basic objectives -Others to investigate the relatonship between OC symptoms and brain volume of each brain region
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes clinical features of obsessive-compulsive symptoms

volume of each brain region
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Other
Interventions/Control_1 OCD with PDD
Interventions/Control_2 OCD without PDD
Interventions/Control_3 healthy control
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
65 years-old >=
Gender Male and Female
Key inclusion criteria patients with OCD diagnosed by DSM-IV-TR

healthy control: those whose age and sex are matched with the patients
Key exclusion criteria Total IQ is less than 80.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shozo Aoki
Organization Kawasaki Medical School
Division name Department of Psychiatry
Zip code
Address 577, Matsushima, Kurashiki Cuty
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kawasaki Medical Shool
Division name Department of Psychiatry
Zip code
Address
TEL
Homepage URL
Email seisinka@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Psychiatry, Kawasaki Medical School
Institute
Department

Funding Source
Organization Japan Society for Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 01 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 Terminated
Date of protocol fixation
2011 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 11 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
2011 Year 09 Month 23 Day
Last modified on
2012 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007594

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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