Major depressive disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Major depressive disorder: (1) Criteria for inclusion of precision teams: 1) Outpatients or inpatients aged 18-65 (including 18 and 65), regardless of gender; 2) Approved by mini7 0.2 regular interview, meeting the diagnostic criteria for the onset of major depressive disorder in the fifth edition of the American Diagnostic and Statistical Manual of mental disorders (DSM-5), either initial or recurrent; 3) Hamilton Depression Scale (HAMD-17) score >= 14 in screening period and baseline period; 4) No antidepressant treatment was taken at least 14 days before enrollment (patients treated with fluoxetine should be stopped for at least 28 days before enrollment); 5) Plan to use a single type of antidepressant treatment; 6) Primary school education or above, able to understand the research content; 7) Understand and voluntarily participate in this study, and sign the informed consent form. (2) Real-world team inclusion criteria: 1) outpatients or inpatients aged >= 16 years, regardless of gender; 2) It meets the diagnostic criteria of major depressive disorder in the fifth edition of the American Diagnostic and Statistical Manual of mental disorders (DSM-5), and can start or relapse; 3) Educational level above primary school, able to understand the content of the scale; 4) Understand and voluntarily participate in this study, and sign the informed consent form. In addition to the above conditions, if the subject meets the following conditions at the same time, collect multimodal imaging, EEG and digital phenotypic indexes: 5) There was no MECT treatment history within 6 months before enrollment; 6) Right-handedness; 7) There are no electronic or metal implants in the body. 2. Bipolar disorder: (1) Age 18-65 years old, regardless of gender; (2) Comply with the diagnostic and Statistical Manual of mental disorders (dsm-5) "bipolar disorder, currently a depressive episode"; (3) Be able to understand and complete the evaluation content; (4) Sign the informed consent form. 3. Healthy control group: (1) Age 18-65 years old, regardless of gender; (2) Be able to understand and complete the evaluation content; (3) I sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Major depressive disorder: (1) Exact queue exclusion criteria: 1) Current or previous diagnosis of other major mental disorders other than depression or bipolar disorder in accordance with DSM-5, such as neurodevelopmental disorder, neurocognitive disorder, schizophrenia and other psychiatric disorders, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, alcohol (or drug) dependence or abuse, personality disorder; 2) A depressive episode of organic mental disorder secondary to a systemic disease or a nervous system disease, such as depression caused by hypothyroidism; 3) Accompanied by serious or unstable cardiovascular, respiratory, liver, kidney, endocrine, hematological or other systemic diseases, the researcher believes that it is not suitable to be included in this study; 4) In the screening or baseline period, the researcher considers that the physical examination and laboratory examination of the patient are abnormal and judged to have obvious clinical significance; 5) Three months before screening, they received systematic modified electrical convulsion therapy (MECT), transcranial magnetic stimulation (TMS), deep brain stimulation (DBS) and vagus nerve stimulation (VNS); 6) Before screening, psychotropic drugs were stopped for less than 7 half-lives; 7) The blood HCG/urine pregnancy test results of pregnant women, lactating women, or women of childbearing age were positive during the screening period; Or men with reproductive potential or women of childbearing age are unable to take effective contraceptive measures during the trial; Or plan to be pregnant within 3 months after the start of the trial; 8) Participated in intervention clinical trials 3 months before screening; 9) For other reasons, the researcher considered it inappropriate to participate in this study. (2) Real-world queue exclusion criteria: 1) current or previous diagnosis of other major mental disorders other than depressive disorder in accordance with DSM-5, such as schizophrenia and other psychotic disorders, bipolar disorder, neurodevelopmental disorder and neurocognitive disorder; 2) At present, researchers with serious physical diseases think it is not suitable to be included in this study; 3) Any other situation that researchers consider unsuitable for inclusion. 2. Bipolar disorder: (1) currently or previously suffering from other major mental disorders in accordance with DSM-5, except "bipolar disorder, which is currently a depressive episode", such as schizophrenia and other psychotic disorders, major depressive disorders, neurodevelopmental disorders and neurocognitive disorders; (2) At present, researchers with serious physical diseases think it is not suitable to be included in this study; (3) Any other situation that researchers consider unsuitable for inclusion. 3. Healthy control group: (1) Current or previous disease diagnosis criteria meeting DSM-V; (2) Those who suffer from serious and unstable physical diseases and are unable to complete the questionnaire survey and examination evaluation; (3) Pregnant or lactating female patients; (4) At present, there is a serious risk of suicide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early onset;Remission;Response;Relapse;Recurrence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalized due to mental illness or emotional events;Switch to (hypo)mania;High risk of suicide;Adverse drug reactions and cumulative drug exposure;Adherence;Social function;Congnitive function;Multigroup index, neuroimaging index and multimodal digital phenotype index; | — |
Countries
China
Contacts
Beijing Anding Hospital, Affiliated to Capital Medical University