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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018915
Receipt No. R000021884
Scientific Title Study for possibility of restoration of damaged higher brain function in malnourished eating disorders.
Date of disclosure of the study information 2015/09/05
Last modified on 2018/03/08

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Basic information
Public title Study for possibility of restoration of damaged higher brain function in malnourished eating disorders.
Acronym Study for possibility of restoration of damaged higher brain function in malnourished eating disorders.
Scientific Title Study for possibility of restoration of damaged higher brain function in malnourished eating disorders.
Scientific Title:Acronym Study for possibility of restoration of damaged higher brain function in malnourished eating disorders.
Region
Japan

Condition
Condition eating disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) By determining the change of higher brain function, the change of cognitive distortion, the change of cerebral volume and neural fiber in MRI study, the endocrinological change and the psychopathological change, and 2)by comparing these instances with those of healthy controls, we are going to clarify the efficacy and the limit of the existent therapy and to develop a new way of therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes cerebral MRI volumetry
Key secondary outcomes questionnaires(BDI-2, EDI-2, BIS-11, PBI, SSQ-6, TCI-125), neuropsychological tasks (WCST, CPT, Stroop test), self-face picture morphing test, neurotrophins.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
17 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria We recruit malnourished eating disorder female patients who are treated in the psychiatric ward of Nagoya University Hospital and who give consent to study participation. Parental consent are also needed when the patient is under 20 or is involuntarily admitted.
Key exclusion criteria under 17 years old or male.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Ozaki
Organization Nagoya University Graduate School of Medicine
Division name Psychiatry
Zip code
Address Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
TEL +81527442282
Email ozaki-n@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Tanaka
Organization Nagoya University Hospital
Division name Psychiatry
Zip code
Address Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
TEL +81527442282
Homepage URL
Email tanakas@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
Address
Tel
Email

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 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2009 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Based on case-control and longitudinal model. We recruit a healthy female without history of psychiatric disorders.

Management information
Registered date
2015 Year 09 Month 04 Day
Last modified on
2018 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021884

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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