UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040042 |
|---|---|
| Receipt number | R000045471 |
| Scientific Title | Investigation of the effects of MANTRA on anorexia nervosa and elucidation of brain mechanisms |
| Date of disclosure of the study information | 2020/04/06 |
| Last modified on | 2021/03/17 11:41:19 |
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Basic information
Public title
Investigation of the effects of MANTRA on anorexia nervosa and elucidation of brain mechanisms
Acronym
Investigation of the effects of MANTRA on anorexia nervosa and elucidation of brain mechanisms
Scientific Title
Investigation of the effects of MANTRA on anorexia nervosa and elucidation of brain mechanisms
Scientific Title:Acronym
Investigation of the effects of MANTRA on anorexia nervosa and elucidation of brain mechanisms
Region
| Japan |
Condition
Condition
anorexia nervosa
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of MANTRA on anorexia nervosa.
To elucidate the neurobiological mechanisms of the treatment process for anorexia nervosa.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
resting-state functional MRI
Key secondary outcomes
1.Body Mass Index(BMI)
2.Eating Disorder Instrument-2(EDI-2)
3.Bulimic Investigatory Test, Edinburgh (BITE)
4.Beck Depression Inventory-2 (BDI-2)
5.State-Trait Anxiety Inventory (STAI)
6.Obsessive Compulsive Inventory(OCI)
7.Liebowitz Social Anxiety Scale(LSAS)
8.Work and Social Adjustment Scale(WSAS)
9.Visual Analogue Scale(VAS): Evaluate treatment motivation, credibility, acceptability, and social support on a scale of 0-10.(only patient treated with MANTRA)
10.Metabolite concentration in the brain measured by H-MRS with measurement area set in medial prefrontal cortex and analyzed by LCModel.
11.Cytokine, Chemokine, growth factor: eotaxin, FGF-2, G-CSF, GM-CSF, IFN-g, IL-1b, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A, IP-10, MCP-1(MCAF), MIP-1a, MIP-1b, PDHF-BB, RANTES, TNF-a, VEGF, CTACK, GRO-a, HGF, ICAM-1, IFN-a2, IL-1a, IL-2Ra, IL-3, IL-12p40, IL-16, IL-18, LIF, MCP-3, M-CSF, MIF, MIG, b-NGF, SCF, SCGF-b, SDF-1a, TNF-b, TRAIL, VCAM-1
12.T1 weighted image
13.T2 weighted image
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Functional connectivity of brain regions by rs-fMRI/ Patient treated with MANTRA
Interventions/Control_2
Functional connectivity of brain regions by rs-fMRI / Normal controls
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
| 18 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
Patient treated with MANTRA
1.Diagnosed as AN by DSM-5
2.BMI 15 or more and less than 18.5
3.Women between the ages of 18 to 55
4.Patients who obtained consent from this study by signing consent form with their own or his / her consent
Normal controls
1.BMI 18 or more and less than 25
2. Women between the ages of 18 to 55
3.Subjects who obtained consent from this study by signing consent form with their own or his / her consent
Key exclusion criteria
Patient treated with MANTRA
1.When the main psychiatric disorders is other than AN
2.Patient with severe physical complications
3.Pregnant
4.Serious suicidal ideation or suicide-related behavior is observed
5.Inappropriate patients for this study judged by physician
Normal controls
1.If the subjects has a history of psychiatric / neurological disorders, including eating disorders, within themselves and within their first degree
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Yamasue |
Organization
Hamamatsu University School of Medicine
Division name
Department of Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu City 431-3192, Japan
TEL
053-435-2295
yamasue@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyo |
| Middle name | |
| Last name | Isobe |
Organization
Hamamatsu University Hospital
Division name
Department of Psychiatry
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu City 431-3192, Japan
TEL
053-435-2295
Homepage URL
isobe@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Review Board of Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashiku, Hamamatsu City 431-3192, Japan
Tel
053-435-2111
rinri@hama-med.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 04 | 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
Management information
Registered date
| 2020 | Year | 04 | Month | 03 | Day |
Last modified on
| 2021 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045471
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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