Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059238) titled 'Well-being in patients with mental illness: a cross-sectional and longitudinal analysis using registry data' on Oct. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Keio University
Condition:
Condition - Mental illness
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study will conduct cross-sectional and longitudinal analyses using diverse data collected from patients with various mental health conditions within the Mental Illness Registry. Specifically, this includes Tier I demographic information and Tier IIa detailed data obtained through ePROs using web questionnaires and optional wearable devices.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - The study will include individuals who are registered with the Mental Illness Registry by 31 March 2025.
The selection criteria for the Registry are as follows:
[Selection criteria]
1. Patients with a mental illness (regardless of diagnosis, age or gender) who have received treatment at a medical institution approved to participate in this study as a collaborative research institution and who have provided written consent for registration in this registry.
2. Healthy individuals (regardless of age or gender) who have obtained written consent for registration at a participating medical institution.
This study will also include minors and individuals lacking the capacity to give consent. When minors or individuals lacking capacity to consent participate in the study, consent will be obtained from both the individual and their legal representative.
[Reasons for including minors and individuals lacking capacity to consent]
Minors and individuals lacking capacity to consent are frequently present among those with mental disorders. The aim of this registry is to clarify the circumstances of patients with mental disorders based on real-world data.
Key exclusion criteria - Individuals deemed unsuitable as research subjects by the principal investigator. Furthermore, the exclusion criteria for the Mental Illness Registry are as follows:
[Exclusion Criteria]
- Individuals who are healthy, patients or surrogate decision-makers from whom consent cannot be obtained
- Individuals deemed unsuitable by the attending physician, such as those for whom participation in this study is expected to worsen their condition
Target Size - 2200
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2024 Year 10 Month 24 Day
Date of IRB - 2024 Year 11 Month 25 Day
Anticipated trial start date - 2024 Year 11 Month 26 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067442
Disclaimer: Curated by HT Syndication.