Software development Integrating wearable technologies for future depression treatment

JRCT ID: jRCT1031210478

Registered date:12/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: As described in the inclusion criteria
• Date of first enrollment: 12/12/2021
• Target sample size: 360
• Study type: Observational

Outcome(s)

Primary Outcome

Estimation by machine learning algorithms of whether or not a depressive episode (as defined in DSM5) (and a score of 8 or more, which is considered a symptom in HAMD) is met.
Total score estimate of HAMD by machine learning algorithm

Secondary Outcome

Estimates of HAMD sub-item scores by machine learning algorithms, estimates of total scores by combining multiple items, and severity classification by score range (below threshold/mild/moderate/severe)
Estimated total score of MADRS by machine learning algorithm, estimated score of sub-items, estimated total score of combined scores of multiple items, and severity classification by score range (normal/mild/moderate/severe)
Estimation of total score of YMRS by machine learning algorithm, estimation of score of sub-items, estimation of total score by combining multiple items, and severity classification by score range (minimal/mild/moderate/severe)
Estimated total score of BDI-II by machine learning algorithm, estimated score of sub-items, estimated total score of combined scores of multiple items, and severity classification by score range (minimal/mild/moderate/severe)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

In the case of patients
1) Patients clinically diagnosed as one of the following groups according to DSM-5 criteria: depressive disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, trauma- and stressor-related disorders, dissociative disorders, somatic symptom and related disorders, and have depressive symptoms, and are on outpatient or inpatient status at Keio University Hospital or research collaborating institutions.
Or, patients with clinically undiagnosed but depressive symptoms who are suspected to have depression (including depression in bipolar disorder) and who are outpatients or inpatients at Keio University Hospital or collaborating institutions.
2) Patients who are 18 years of age or older at the time of obtaining consent.
3) Patients for whom the attending physician judges that written consent can be obtained, or who can obtain consent from a substitute if the attending physician judges that it is difficult to obtain consent from the patient.
4) A person who owns and uses a smart phone (iOS 11.0 or later or Android version 5.0 or later)
In the case of a healthy person
1) A healthy person with no history of psychiatric illness who has volunteered to cooperate in the study (after obtaining consent, the M.I.N.I. will be used to confirm that the person does not have a psychiatric illness)
2) Age 18 years or older at the time of obtaining consent
3) Own and use a smart phone (iOS 11.0 or later or Android version 5.0 or later)

Exclude criteria

In the case of patients
1) Patients who are judged by the attending physician to be mentally or physically overloaded by the measurements taken in this study, which may affect their medical conditions.
2) Patients suffering from comorbidities such as paralysis of the upper limbs that may affect the measurement results of the wristband wearable device.
3) Other patients deemed inappropriate by the principal investigator or sub-investigator.
In the case of healthy person
1) Persons suffering from comorbidities that may affect the measurement results of the wristband wearable device, such as paralysis of the upper limbs.
2) Others who are judged to be inappropriate by the principal investigator or sub-investigator

Related Information

• Primary Sponsor: Kikuchi Toshiaki
• Secondary Sponsor: Kishimoto Taishiro
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development (AMED)