UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008765
Receipt number R000010298
Scientific Title A morphometric MRI study on obsessive compulsive disorder with and without pervasive developmental disorder
Date of disclosure of the study information 2012/11/01
Last modified on 2019/03/13 16:13:34

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Basic information

Public title

A morphometric MRI study on obsessive compulsive disorder with and without pervasive developmental disorder

Acronym

A morphometric MRI study on OCD with and without PDD

Scientific Title

A morphometric MRI study on obsessive compulsive disorder with and without pervasive developmental disorder

Scientific Title:Acronym

A morphometric MRI study on OCD with and without PDD

Region

Japan


Condition

Condition

obsessive compulsive disorder
pervasive developmental disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of obsessive compulsive disorder and pervasive developmental disorder

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

volume of each brain lesion and diffusion anisotrophy of nerve fibers

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

MRI imaging

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

18 years-old <

Age-upper limit

45 years-old >=

Gender

Male and Female

Key inclusion criteria

Moderate and severe OCD patients diagnosed by SCID

Key exclusion criteria

mental retardation
organic brain syndrome]
psychosis

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akiko Nakagawa

Organization

Chiba Unversity

Division name

Research Center for Mental Development

Zip code


Address

1-8-1, Inohana, Chuo-ku , Chiba City

TEL

043-226-2975

Email

akikon@chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akiko Nakagawa

Organization

Chiba University

Division name

Research Center for Mental Development

Zip code


Address

1-8-1, Inohana, Chuo-ku , Chiba City

TEL

0432262975

Homepage URL


Email

chibarccmd@ML.chiba-u.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

Grant in Aid for Scientific Research

Organization

Division

Category of Funding Organization

Non profit foundation

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

千葉大学病院(千葉県)


Other administrative information

Date of disclosure of the study information

2012 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

Enrolling by invitation

Date of protocol fixation

2012 Year 10 Month 31 Day

Date of IRB

2012 Year 05 Month 30 Day

Anticipated trial start date

2012 Year 11 Month 01 Day

Last follow-up date

2016 Year 08 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 08 Month 24 Day

Last modified on

2019 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010298


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name