UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010220
Receipt number R000011970
Scientific Title An MRI study of the neural basis of eating disorder and the effect of cognitive behavioral therapy
Date of disclosure of the study information 2013/03/13
Last modified on 2021/03/18 16:55:27

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Basic information

Public title

An MRI study of the neural basis of eating disorder and the effect of cognitive behavioral therapy

Acronym

An MRI study of the neural basis of eating disorder and the effect of cognitive behavioral therapy

Scientific Title

An MRI study of the neural basis of eating disorder and the effect of cognitive behavioral therapy

Scientific Title:Acronym

An MRI study of the neural basis of eating disorder and the effect of cognitive behavioral therapy

Region

Japan


Condition

Condition

Patients with eating disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to search the biological markers of eating disorder in the brain activity for body and food image, facial expression, and taste processing by functional MRI and investigate the effect cognitive behavioral therapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation between craving and fMRI signal

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Cognitive behavioral therapy

Interventions/Control_2

Treatment as usual

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

13 years-old <=

Age-upper limit

40 years-old >

Gender

Female

Key inclusion criteria

Primary diagnosis of eating disorder and healthy individuals

Key exclusion criteria

Individuals with who have histories of substance abuse, active suicidality, severe mental and physical condition, body mass index < 14, global assesment of functioning < 50, pervasive development disorder, intelligence quotient < 80, eating disorder examination questionnaire > 2.8 for health control, mood disorder (major depression, bipolar), and psychiatric disorders associated with substance abuse

Target sample size

75


Research contact person

Name of lead principal investigator

1st name Eiji
Middle name
Last name Shimizu

Organization

Chiba University

Division name

Research Center for Child Mental Development,

Zip code

260-8670

Address

1-8-1 Inohana, Chuouku, Chiba, Japan

TEL

043-226-2027

Email

eiji@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Yoshiyuki
Middle name
Last name Hirano

Organization

Chiba University

Division name

Research Center for Child Mental Development,

Zip code

260-8670

Address

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

TEL

043-226-2975

Homepage URL


Email

hirano@chiba-u.jp


Sponsor or person

Institute

Chiba University

Institute

Department

Personal name



Funding Source

Organization

Japan Ministry of Health and Labor

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Ethics Council of the Graduate School of Medicine, Chiba University

Address

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

Tel

043-222-7171

Email

igaku-rinri@office.chiba-u.jp


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

2013 Year 03 Month 13 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

Completed

Date of protocol fixation

2012 Year 12 Month 01 Day

Date of IRB

2012 Year 05 Month 31 Day

Anticipated trial start date

2012 Year 12 Month 01 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 03 Month 12 Day

Last modified on

2021 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011970


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name