Psychiatric Symptoms for COVID-19 Registry Japan

JRCT ID: jRCT1030220711

Registered date:17/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Post COVID-19 condition
• Date of first enrollment: 01/01/2023
• Target sample size: 1000
• Study type: Observational

Outcome(s)

Primary Outcome

Tier 1 information: presence or absence of various symptoms of the study subjects (fever, cough, wet cough, blood sputum/hematoptysis, sore throat, wheezing, dyspnea/shortness of breath, chest pain, myalgia/arthralgia, convulsions, difficulty walking, enlarged lymph nodes, headache, altered consciousness/distraction, tiredness/fatigue, loss of appetite, abdominal pain, vomiting/nausea, diarrhea, abnormal sense of taste, abnormal sense of smell, conjunctivitis, and skin rash), basic information (demographic information, residence, marital status, presence of children, schooling/working status, class/working status, communication with family members and others), and basic information (demographic information, residence, marital status, presence of children, schooling/working status, class/working status, family and others). skin rash), basic information (demographic information, residential status, marital status, presence of children, schooling/work status, class/work status, communication with family/others), impact of new coronavirus sequelae, change in frequency of outings, worry, history of infection, diagnosis, history of testing, vaccination history, vaccination frequency, psychiatric treatment history.
Tier 2 information: Cognitive function assessment (10 minutes): MoCA-J (Japanese version of Montreal Cognitive Assessment), Clinical global impression-severity assessment (2 minutes): CGI-S (Clinical Global Impression-severity) [Tier 2b information]: PHQ-9 (Patient Health Questionnaire-9), GAD-7 (Generalized Anxiety Disoeder-7), ISI (Insomnia Severity Index), and PDQ-D5 (Perceived Deficits Questionnaire-Depression 5), EuroQol-5D-5L (EQ 5D-5L), SWLS (Satisfaction with Life Scale) All questionnaires [Tier 2 a information], prescription details and drug history: prescription and drug history information [layer 2a information]
Tier 3 samples and information: Biological samples: blood (plasma, DNA) 20 mL Biological information: information obtained from analysis of biological samples, and brain neuroimaging (3D-T1, 3D-T2, rsfMRI, DTI, NM-MRI) and information obtained from their analysis - ePRO input information**: Layer 2a information, name, gender, birth date, name of medical institution, telephone number, e-mail address (name, telephone number and e-mail address are managed only within ePRO secretariat), etc.

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients (16 years of age or older, regardless of diagnosis or gender) who have received care at a medical institution approved to participate in this study as a collaborating institution due to COVID-19 infection, who have psychiatric symptoms after infection, and who have given written consent for enrollment in this registry. Minors and persons lacking the capacity to consent will be included in this study. If minors or persons lacking the capacity to consent wish to participate in the study, consent shall be obtained from the person himself/herself as well as from a substitute consenting party. In the first year of the study, minors under 16 years of age will not be included, and for minors under 18 years of age, consent will be obtained from the individual and a surrogate.
As for the non-infected control group, healthy subjects obtained in the previous research project "Elucidation of Diversity and Age-related Changes in Neural Circuitry in the Human Brain" at Nagoya University will be included.

• Exclude criteria: Those who are unable to obtain the consent of the patient or those whose participation in this study is deemed inappropriate by the attending physician, such as those whose medical condition is expected to worsen as a result of participating in this study.

Related Information

• Primary Sponsor: Kito Shinsuke
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Japan Agency for Medical Research and Development