UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041996 |
|---|---|
| Receipt number | 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 | 2022/03/17 15:21:52 |
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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
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
toshiro@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
60
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
No longer recruiting
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
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047928
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