Bipolar disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Bipolar group: 1.Outpatients or inpatients between the ages of 16 and 55, regardless of gender. 2.The subjects voluntarily participated in this experiment and signed the informed consent form, and were able to abide by the planned visit, laboratory examination and other research procedures. 3.According to the American Classification and Diagnostic Criteria for Mental Disorders (DSM-5), he was diagnosed as bipolar disorder. 4.HAM-D17 total score =17 or YMRS=7. 5.The score of CGI-SI in the General Evaluation Scale of Clinical Efficacy is =4. Stress group: 1.Participants voluntarily participated in the trial and signed an informed consent form, and were able to comply with planned visits, laboratory tests and other study procedures 2.Men and women aged 16 to 55 3.Being in an event that can cause stress (exams, interviews, etc.)
Exclusion criteria
Exclusion criteria: Bipolar group: 1.There are other serious physical diseases or concurrent diseases. 2.Have serious nervous system diseases, a clear family history or potential risks. 3.According to DSM-5 standard, it meets the diagnosis of other mental diseases. 4.Patients who need to take benzodiazepines every day, use them within 3 months or need electroconvulsive therapy at present. 5.Those who have received systematic psychotherapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy) or transcranial magnetic stimulation therapy (TMS) within 3 months before screening. 6.Those who regularly take NSAIDs, COX-2 inhibitors, immunosuppressants, hormone drugs, interferon, chemotherapy drugs and anticoagulants for a long time within one week of the screening period or throughout the experimental period. 7.Pregnant or lactating women, women with pregnancy plans during the experimental period (12 months) and women with high risk of pregnancy but without taking any contraceptive measures. 8.There is obvious suicidal attempt or behavior, and the score of item 10 (suicidal ideation) of MADRS scale is =4. 9.Accompanied by serious unstable cardiovascular diseases, liver diseases, kidney diseases, blood diseases, endocrine diseases, malignant tumors, active autoimmune diseases and inflammatory bowel diseases and other physical diseases or medical history. 10.Other serious acute or chronic diseases, mental illness or abnormal laboratory examination have clinical significance, and the researcher judges that the subject is not suitable to participate in this study. 11.Contraindications of MRI examination Stress group: 1.There are other serious physical or concomitant diseases 2.There is a significant neurological disease with a clear family history or potential risk 3.According to the DSM-5 criteria, it fits with other mental illness diagnoses 4.Patients with severe and unstable cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, malignant tumor, active autoimmune disease, inflammatory bowel disease and other physical diseases or medical history 5.Other serious acute or chronic diseases, mental illness or clinically significant laboratory abnormalities that the investigator determines are not suitable for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale score;Yang's Manic Scale score;Routine blood test;Blood biochemistry; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale score;Score of the repetitive set of neuropsychological state assessment scales;CD4+T cell;IL-17;IL-22;IL-23;Score of the Generalized Anxiety Scale;Resting-state MRI; | — |
Countries
China
Contacts
Xiangya Second Hospital of Central South University