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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040042
Receipt No. 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 2020/10/06

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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
Email 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
Email isobe@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email 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 Open public recruiting
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
2020 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045471

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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