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A Study Comparing Depressed Patients and Healthy Subjects Using Long-Term ECG and Triaxial Accelerometer

A Study Comparing Depressed Patients and Healthy Subjects Using Long-Term ECG and Triaxial Accelerometer - A Study Comparing Depressed Patients and Healthy Subjects Using Long-Term ECG and Triaxial Accelerometer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000041996
Enrollment
60
Registered
2020-10-05
Start date
2020-10-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder

Interventions

None listed

Sponsors

Keio University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
heart rate variability

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactToshiro Horigome

Keio University School of Medicine Neuropsychiatry

toshiro@keio.jp0353633492

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026