UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000011970