UMIN-CTR Clinical Trial

Public title

Cross-sectional study on autonomic predictive responses and interoception to elucidate the pathogenic mechanism of somatic symptom disorder

Acronym

Study to elucidate the mechanism of somatic symptom disorder

Scientific Title

Cross-sectional study on autonomic predictive responses and interoception to elucidate the pathogenic mechanism of somatic symptom disorder

Scientific Title:Acronym

Study to elucidate the mechanism of somatic symptom disorder

Region

Japan

Condition

Somatic symptom and related disorders

Classification by specialty

Medicine in general	Psychosomatic Internal Medicine	Psychiatry
Orthopedics	Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the pathogenesis of somatic symptoms and related disorders by comparing them with healthy subjects.

Basic objectives2

Others

Basic objectives -Others

To explore the relationship between the severity of symptoms and various tests.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Interrelationships among autonomic responses, interoception, and cognitive function

Key secondary outcomes

1)Autonomic responses (baroreceptor sensitivity, heart rate variability), 2) accuracy of interoception, 3) body image in the embody task, 4) meaningful decision traits (jumping to conclusion task, automatic thinking task), 5) sensory classification tasks, 6) pain threshold (using pain quantitative analyzer), 7)physical symptom assessment using variable questionnaires(PHQ-15, SSS-8, SSD-12, SSAS, SHAI, BPI, HADS, K10, PCS, MAIA, FFMQ, CFQ, AAQ2, SF-8, EQ-5D, TAS-20, AQ-J, IAS-J, IATS-J), 8) head MRI including resting state-functional MRI

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

<Healthy group>
(1) Those who are able to participate in all experiments and answer the questionnaires.
(2) Those who have no history of mental illness in the past, or those who have had a history of mental illness and have recovered for at least two years.
(3) Those who have physical illnesses that the principal investigator judges will not interfere with their participation in the study.
(4) Those who are at least 20 years old but less than 60 years old at the time of study participation.
(5) Those who can provide written consent to participate in the study.

<Disease group>
(1) Those who can participate in all experiments and answer the questionnaire.
(2) Those who have been diagnosed as somatic symptom and related disorders (including pain disorders, psychophysiological disorders, and autonomic disorders) by medical examination.
(3) Those who have no history of psychiatric disorders other than somatic symptoms and related disorders, or those whose participation in the study is judged by the principal investigator to be safe even if they do have a history of psychiatric disorders.
(4) Those who have physical illnesses that the principal investigator can judge will not interfere with their participation in the research.
(5) Those who are at least 20 years old and under 60 years old at the time of participation in the study.
(6) Those who can provide written consent to participate in the study.

Key exclusion criteria

(1) Patients who are judged by the principal investigator to have a serious mental illness that makes it difficult for them to participate in the research.
(2) Patients who are judged by the principal investigator to have a serious physical illness that makes it difficult for them to participate in the research.
(3) Patients who are judged by the principal investigator to have serious physical illnesses that make it difficult for them to participate in the research.

Target sample size

300

Name of lead principal investigator

1st name	Masaru
Middle name
Last name	Mimura

Organization

Keio University

Division name

Center for Preventive Medicine

Zip code

106-0041

Address

Azabudai Hills Mori JP Tower 7th Floor, 1-3-1 Azabudai, Minato-ku, Tokyo, Japan

TEL

03-5363-3685

Email

mimura.a7@keio.jp

Name of contact person

1st name	Yuki
Middle name
Last name	Mashima

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3829

Homepage URL

Email

yukimashima@keio.jp

Institute

Keio University School of Medicine Department of Neuropsychiatry

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Keio University Faculty of Letters

Name of secondary funder(s)

Organization

Keio University Institutional Review Board

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学病院（東京都）、慶應義塾大学三田キャンパス（東京都）

Date of disclosure of the study information

2021

Year

08

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2021

Year

06

Month

22

Day

Date of IRB

2021

Year

07

Month

30

Day

Anticipated trial start date

2021

Year

08

Month

02

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a prospective registry study: patients with somatic symptoms and related disorders who visit the Department of Neuropsychiatry, Department of General Medicine, and Department of Anesthesiology Pain Center at Keio University Hospital between August 2021 and March 2026 and who give consent to participate in the study will be enrolled. The age-and gender- matched healthy people will be also recruited as healthy controls.
They will be asked to perform some autonomic-nerve-system ,interoception-related tasks, somatic-symptom-related questionnaires and head MRI including resting state-functional MRI.
Mathematical analysis focusing on causal analysis and modeling analysis using a computational approach with Bayesian statistics will be conducted to reveal the autonomic prediction system and its abnormalities in patients with somatic symptoms and related disorders.
The goal is to develop a pathophysiological model that can provide potentially therapeutic targets.

Registered date

2021

Year

08

Month

02

Day

Last modified on

2026

Year

08

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050646