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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041996
Receipt No. R000047928
Scientific Title A Study Comparing Depressed Patients and Healthy Subjects Using Long-Term ECG and Triaxial Accelerometer
Date of disclosure of the study information 2020/10/05
Last modified on 2020/12/21

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Basic information
Public title A Study Comparing Depressed Patients and Healthy Subjects Using Long-Term ECG and Triaxial Accelerometer
Acronym A Study Comparing Depressed Patients and Healthy Subjects Using Long-Term ECG and Triaxial Accelerometer
Scientific Title A Study Comparing Depressed Patients and Healthy Subjects Using Long-Term ECG and Triaxial Accelerometer
Scientific Title:Acronym A Study Comparing Depressed Patients and Healthy Subjects Using Long-Term ECG and Triaxial Accelerometer
Region
Japan

Condition
Condition Major depressive disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will use a wearable electrocardiograph (HeartnoteTM) to measure long-term electrocardiograms and a built-in triaxial accelerometer in depressed and healthy patients, and examine the differences between the two groups based on the results of 7 days of measurements. In addition to biostatistical analysis, we will attempt to discriminate between disease states and severity of illness using machine learning.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes heart rate variability
Key secondary outcomes Beck Depression Inventory, PHQ-9, State-Trait Anxiety Inventory, Hamilton Rating Scale for Depression, Montgomery-Asberg Depression Rating Scale, Physical activity, posture, activity, physical activity, and sleep

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria <for patients>
1) Patients 20 years of age or older with a diagnosis of major depressive disorder according to DSM-5 diagnostic criteria
2) Patients determined by the attending physician to be competent to make consenting decisions.

<for healthy controls>.
1) Healthy individuals with no history of mental illness who have volunteered to participate in the study based on web advertisements, bulletin boards, email recruitment ads, etc., or through their organizations.
2) Those who were 20 years of age or older at the time of obtaining consent.
Key exclusion criteria 1) Patients who may have difficulty applying HeartnoteTM due to skin sensitivity, metal allergies, body hair, etc.
2) Patients with cardiac or physical diseases that can affect ECG or accelerometer assessment data (e.g., arrhythmia, myocardial infarction, Parkinson's disease)
3) Patients who are on treatment that may have a significant effect on the ECG or body movements (e.g., ECT, TMS, beta-blockers, anticholinergics, antiarrhythmics, antihypertensive medications, etc.)
4) Patients with suicidal ideation
5) Patients with comorbid psychiatric disorders other than depression
6) When the principal investigator or sub-investigator decides that it is inappropriate to do so
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Taishiro
Middle name
Last name Kishimoto
Organization Keio University School of Medicine
Division name Neuropsychiatry
Zip code 160-8582
Address Shinanomachi35, Shinjuku, Tokyo, Japan
TEL 0353633492
Email tkishimoto@keio.jp

Public contact
Name of contact person
1st name Toshiro
Middle name
Last name Horigome
Organization Keio University School of Medicine
Division name Neuropsychiatry
Zip code 160-8582
Address Shinanomachi35, Shinjuku, Tokyo, Japan
TEL 0353633492
Homepage URL
Email toshiro@keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization JSR-Keio University Medical and Chemical Innovation Center
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 Keio University School of Medicine Ethics Committee
Address Shinanomachi35, Shinjuku, Tokyo, Japan
Tel 03-5363-3503
Email med-rinri-jimu@adst.keio.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 20200163
Org. issuing International ID_1 Keio University School of Medicine Ethics Committee
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 10 Month 05 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 08 Month 03 Day
Date of IRB
2020 Year 09 Month 03 Day
Anticipated trial start date
2020 Year 10 Month 05 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2025 Year 03 Month 31 Day

Other
Other related information <For patients>
The treating physician interviews the attending physician for a General Clinical Impression (CGI) and obtains background information from the medical record, including age, gender, medications, and duration of the disease.The HAMD and MADRS are assessed, and then the subject wears the Heartnote and lives free for 7 days. He will complete a self-administered questionnaire assessment at some point during the 7-day wear. For the self-administered questionnaire, the following information will be enforced
Beck Depression Questionnaire (BDI)
PHQ-9
State-Trait Anxiety Inventory (STAI)
The assessment shall be performed twice per examinee with a minimum of two weeks' interval.


<For healthy controls>.
Information such as age, gender, medical history, and medications will be confirmed in writing.The subject will then wear the Heartnote and live freely with no restrictions for 7 days. He will complete a self-administered questionnaire at any point during the seven days of wear. The following information will be administered for the self-administered questionnaire
Beck Depression Questionnaire (BDI)
PHQ-9
State-Trait Anxiety Inventory (STAI)
Assessments shall be conducted twice with a minimum of two (2) weeks between each examinee.

Management information
Registered date
2020 Year 10 Month 03 Day
Last modified on
2020 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047928

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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