UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015321
Receipt number R000017729
Scientific Title An MRI study on neural basis of cognitive restructuring for obsessive-compulsive disorder
Date of disclosure of the study information 2014/10/15
Last modified on 2014/09/26 10:08:27

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Basic information

Public title

An MRI study on neural basis of cognitive restructuring for obsessive-compulsive disorder

Acronym

An MRI study on neural basis of cognitive restructuring for OCD

Scientific Title

An MRI study on neural basis of cognitive restructuring for obsessive-compulsive disorder

Scientific Title:Acronym

An MRI study on neural basis of cognitive restructuring for OCD

Region

Japan


Condition

Condition

obsessive-compulsive disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine neural mechanism of cognitive restructuring in obsessive-compulsive disorder

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

BOLD signal, volume, and diffusion anisotoropy in the 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

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Patients with obsessive-compulsive disorder

Interventions/Control_2

Healthy control

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

50 years-old >

Gender

Male and Female

Key inclusion criteria

OCD patients diagnosed by SCID and healthy individuals

Key exclusion criteria

Mental retardation, organic brain syndrome, schizophrenia, bipolar disorder

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiji Shimizu

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Cognitive Behavioral Physiology

Zip code


Address

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

TEL

043-226-2027

Email

eiji@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Chihiro Sutoh

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Cognitive Behavioral Physiology

Zip code


Address

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

TEL

043-226-2027

Homepage URL


Email

csutoh@graduate.chiba-u.jp


Sponsor or person

Institute

Graduate School of Medicine, 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

YES

Study ID_1

14-008

Org. issuing International ID_1

National Institute of Radiological Sciences

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 15 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

2014 Year 07 Month 02 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 15 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

2014 Year 10 Month 02 Day

Last modified on

2014 Year 09 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017729


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name