Mental illness
Conditions
Interventions
None listed
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Well-being indicators: Satisfaction with Life Scale (SWLS) and the UCLA Loneliness Scale (ULS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Basic information on research subjects (Tier I information): - Demographic information - Psychiatric diagnosis - Comorbid conditions - Allergies - Family history - Past medical history - History of suicide attempts - Smoking history - History of problem drinking - Substance abuse history - Educational background - Occupation - Educational/employment status - Marital status - Family composition - Presence of a caregiver - Medical history - Tests (brain imaging/function, blood biochemistry, ECG/X-ray status and presence of abnormal findings) - Prescription history (5 years) - Clozapine treatment history - Non-pharmacological treatment history - Behavioral restrictions - Receipt of disability welfare services (Tier IIa information): Insomnia Scale (AIS), sleep diary, Positive and Negative Affect Schedule (PANAS), Behavioral Inhibition, System and Behavioral Activation System Scale (BIS/BAS), State-Trait Anxiety Inventory (STAI), EuroQol-5D-5L (EQ-5D-5L), Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and Hyperarousal Scale. Prescription details/medication history: Prescription/medication history information. Follow-up information Treatment status, living environment, presence of cohabitants, marital status, education/employment status, medication adherence, use of disability and welfare services. Positive and Negative Affect Schedule (PANAS), Behavioral Inhibition System and Behavioral Activation System Scale (BIS/BAS), State-Trait Anxiety Inventory (STAI), EuroQol-5D-5L (EQ-5D-5L), Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI). | — |
Countries
Japan
Contacts
Public ContactMikiko Yamauchi
Keio University School of Medicine
Outcome results
None listed