Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060436) titled 'An Observational Study Using Wearable Devices for the Exploration of Digital Biomarkers in Psychiatric Disorders' on June 1.
Study Type:
Observational
Primary Sponsor:
Institute - Otsuka Pharmaceutical Co., Ltd.
Condition:
Condition - Psychiatric Disorders
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To explore and characterize digital biomarkers associated with psychiatric disorders by using data for wearable devices in patients and healthy controls, and to compare findings across disorders.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria -
1) Participants who are eighteen years of age or older and younger than seventy years of age at the time of screening
2) Participants who are diagnosed with the relevant psychiatric disorder according to the DSM-5 diagnostic criteria
1) Participants who are eighteen years of age or older and younger than seventy years of age at the time of screening
Key exclusion criteria -
1) Participants for whom the investigator determines at screening that completion of the study is not feasible.
1) Participants with a current or past history of psychiatric disorders.
2) Participants for whom the investigator determines at screening that completion of the study is not feasible.
Target Size - 125
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 23 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069141
Disclaimer: Curated by HT Syndication.
