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
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
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
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
