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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010220
Receipt No. 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

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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
Institute Chiba University
Institute
Department

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
URL(English) https://upload.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


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