UMIN-CTR Clinical Trial

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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