UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059591 |
|---|---|
| Receipt number | R000068161 |
| Scientific Title | Simultaneous Assessment of Psychosocial and Biological Factors Associated with Eating-Disorder Psychopathology in Patients with Anorexia Nervosa: A Multicenter Prospective Observational Study |
| Date of disclosure of the study information | 2025/11/18 |
| Last modified on | 2025/10/30 15:50:07 |
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Basic information
Public title
Exploratory Study of Psychosocial and Biological Factors Involved in the Pathophysiology of Anorexia Nervosa
Acronym
AN-PSYBIO
Scientific Title
Simultaneous Assessment of Psychosocial and Biological Factors Associated with Eating-Disorder Psychopathology in Patients with Anorexia Nervosa: A Multicenter Prospective Observational Study
Scientific Title:Acronym
AN-PSYBIO
Region
| Japan |
Condition
Condition
Anorexia nervosa
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To simultaneously assess psychosocial factors (e.g., self-compassion, rumination, mindfulness, temperament/character, attachment, social cognition) and blood-based biological measures in patients with anorexia nervosa, and to explore their associations with eating-disorder psychopathology (EDE-Q).
Basic objectives2
Others
Basic objectives -Others
Examine associations between each psychosocial factor and EDE-Q subscales.
Explore relationships of biological indices (plasma/serum proteins, mRNA expression, MCT1/MCT4 polymorphisms, and iMG cytokine production) with eating-disorder psychopathology.
Characterize psychosocial-biological interactions in a hypothesis-generating manner to estimate effect sizes and inform future intervention targets.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Global score on the Eating Disorder Examination Questionnaire (EDE-Q 6.0).
Key secondary outcomes
EDE-Q subscale score: Restraint
EDE-Q subscale score: Eating Concern
EDE-Q subscale score: Shape Concern
EDE-Q subscale score: Weight Concern
SCS score
ACSo score
PDQ-5 score
Plasma/serum protein concentrations
Expression levels of selected mRNAs
Presence of MCT1 (T1470A) and MCT4 (C641T) polymorphisms
Cytokine production of induced microglia-like cells (iMG).
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
| 18 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age 18-59 at consent
Diagnosis of anorexia nervosa per DSM-5-TR
No change in psychotropic medication dose during the past 2 weeks
Ability to provide written informed consent
Key exclusion criteria
Presence of physical or psychiatric conditions that preclude study procedures
Insufficient Japanese proficiency to complete self-report questionnaires
Deemed inappropriate for inclusion by the principal investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | A |
| Last name | Kato |
Organization
Hokkaido University Hospital
Division name
Department of Psychiatry and Neurology
Zip code
0608648
Address
Department of Psychiatry and Neurology, Hokkaido University Hospital, North 14 West 5, Kita-ku, Sapporo
TEL
0117161161
takato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | FUMIYA |
| Middle name | |
| Last name | MIYANO |
Organization
Hokkaido University Hospital
Division name
Department of Psychiatry and Neurology
Zip code
0608648
Address
Department of Psychiatry and Neurology, Hokkaido University Hospital, North 14 West 5, Kita-ku, Sapp
TEL
09040705487
Homepage URL
hap19911101@gmail.com
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Mental Health Okamoto Memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Institutional Review Board
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2025 | Year | 11 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: Prospective multicenter observational, single group.
Target sample size: 150 (assuming 118 valid responses).
Participants: Anorexia nervosa per DSM-5-TR, age 18-59.
Assessment timing: Baseline after consent; self-report scales (incl. EDE-Q) and blood sampling.
Biological indices: plasma/serum proteins (oxytocin, orexin, leptin, ghrelin, lactate, ketone bodies, TNF-a, IL-1b, IL-6, CCL11, tryptophan/kynurenine pathway, serotonin, melatonin, GLP-1, GIP, IGF-1) and mRNA expression of receptor panels (OXTR, orexin/leptin/melanocortin/serotonin receptors, chemokine receptors, GLUT, MCT).
Hokkaido University Hospital subset only: MCT1 T1470A and MCT4 C641T polymorphisms; induced microglia-like cells (iMG) cytokine expression/production.
Biospecimen handling: aliquoted at each site, stored at -80C, shipped frozen to Department of Psychiatry, Hokkaido University for measurement and storage.
Analysis: primary outcome is EDE-Q global score; multiple regression with age, body weight, AN subtype, SCS factors, PHQ-9, etc.; exploratory associations with other psychosocial and biological indices.
Ethics: IRB approval and institutional permission at each site; protocol amendments require re-approval.
Not a post-marketing survey.
Management information
Registered date
| 2025 | Year | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068161
