UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018915 |
|---|---|
| Receipt number | 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 | 2023/07/27 16:57:12 |
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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 | Norio |
| Middle name | |
| Last name | Ozaki |
Organization
Nagoya University Graduate School of Medicine
Division name
Psychiatry
Zip code
466-8550
Address
Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
TEL
+81527442282
ozaki-n@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Tanaka |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Clinical Research Center
Zip code
460-0001
Address
Sannnomaru 4-1-1, Nakaku, Nagoya City, Aichi Pref., Japan
TEL
052-951-1111
Homepage URL
tanakas@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
The ethics review committees at Nagoya University Graduate School of Medicine and Nagoya University Hospital
Address
Tsurumaicho 65, showa-ku, Nagoya City, Aichi, Japan
Tel
+81527412111
iijima@med.nagoya-u.ac.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
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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2009 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2009 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
