UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017456 |
|---|---|
| Receipt number | R000019303 |
| Scientific Title | A Multi-Site Study on the Brain Function and Structure of Patients with Eating Disorders |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2023/02/08 19:44:11 |
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Basic information
Public title
A Multi-Site Study on the Brain Function and Structure of Patients with Eating Disorders
Acronym
A Multi-site Study on the Brain of Eating Disorder Patients
Scientific Title
A Multi-Site Study on the Brain Function and Structure of Patients with Eating Disorders
Scientific Title:Acronym
A Multi-site Study on the Brain of Eating Disorder Patients
Region
| Japan |
Condition
Condition
Anorexia nervosa
Bulimia nervosa
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the brain of patients with anorexia nervosa and bulimia nervosa with neuroimaging techniques targeting gray matter, white matter and resting state neural activity. To observe change in the brain of the patients through treatment and estimate the prognostic factors.
Basic objectives2
Others
Basic objectives -Others
Data of Voxel Based Morphometry, Diffusion Tensor Imaging, and resting state functional MRI after treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Data of Voxel Based Morphometry, Diffusion Tensor Imaging, and resting state functional MRI after treatment
Key secondary outcomes
Clinical Global Impression Severity Scale (CGI-S), Global Clinical Score (GCS), Eating Disorder Inventory version 2 (EDI II), Eating Disorder Examination Questionnaire (EDE-Q), Beck Depression Inventory version 2 (BDI-II), State Trait Anxiety Inventory (STAI), Self Efficacy Scale (SES), Maudsley Obsessional-Compulsive Inventory (MOCI), Barratt Impulsiveness Scale (BIS-11), Toronto Alexithymia Scale (TAS-20), Autism Spectrum Quotient (AQ).
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with anorexia nervosa(AN) and bulimia nervosa (BN) who fulfill the criteria of Diagnostic Statistical Manual for Mental Disorders version 5. AN patients include both restrictive type and binge-purge type. Persons recovered from AN and BN. Healthy Persons.
Key exclusion criteria
We exclude persons who are implanted a pacemaker or an intracranial clip, and persons with an accidental metallic implant object and its possibility, or an orthodontic bridge. Patients with a past history of clausrtophobia, head trauma, or neurological disorders are excluded. Although persons with a past history of psychiatric diseases would be excluded, AN or BN patients who suffer from depression, anxiety disorder, or personality disorder would not be excluded because these diseases are frequently comorbid with AN and BN. Pregnant women, breast-feeding women would be excluded. Women who turned out to be pregnant after registration would also be excluded.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Fukudo |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Psychosomatic Medicine
Zip code
980-8575
Address
2-1 Seiryo-machi Aoba-ku Sendai, Miyagi, 980-8575, Japan
TEL
022-717-8160
sfukudo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ysasuhiro |
| Middle name | |
| Last name | Sato |
Organization
Tohoku University Hospital
Division name
Department of Psychosomatic Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi Aoba-ku Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7327
Homepage URL
yassat@hosp.tohoku.ac.jp
Sponsor or person
Institute
Japan Eating Disorder Consortium (JEDC)
Institute
Department
Personal name
Funding Source
Organization
Institute of Development, Aging and Cancer, Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tohoku University Graduate School of Medicine
Address
2-1Seiryo-machi Aoba-ku Sendai, Miyagi, 980-8575, Japan
Tel
022-717-7145
med-kenkyo@bureau.tohoku.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2014-1-865
Org. issuing International ID_1
The Ethics Committee of Tohoku University Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州大学病院（福岡県）
産業医科大学病院（福岡県）
京都大学医学部附属病院精神科神経科（京都府）
千葉大学医学部附属病院（千葉県）
国立精神・神経医療研究センター（東京）
東北大学加齢医学研究所（宮城県）
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019303
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
| Delay expected |
Results Delay Reason
A paper reporting results is in submission.
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to observe the relevance between neuroimaging data of patients with AN and BN, and interventions by every participating facility.
Management information
Registered date
| 2015 | Year | 05 | Month | 07 | Day |
Last modified on
| 2023 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019303
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/05/30 | 脳画像共同研究プロトコル第2.1版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
