Major Depressive Disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Inclusion criteria: If the answer to each of the following statements is "yes", participants can participate in the study. 1) Determine through SCID that the subject meets the DSM-5 diagnostic criteria for severe depressive episodes and has no history of mania Or mild manic episodes, diagnosed as severe depressive disorder by two or more attending psychiatrists; 2) Currently in the stage of depressive episodes (MADRS = 22); 3) The current disease period is within one year; 4) At least two sufficient doses of SSRIs/SNRIs antidepressants (= conventional treatment dose of antidepressants) Foot therapy course (= 6 weeks) treatment is ineffective or partially effective; 5) Participants entering randomized, single blind, and controlled trials must meet the requirement of peripheral blood hypersensitivity C-reactive protein (Hs-CRP)=3mg/L; 6) Age range from 18 to 40 years old (with fewer factors affecting inflammation levels), regardless of gender; 7) Han Chinese, right-handed; 8) Junior high school or above education level, capable of providing informed consent and related tests; 9) Voluntarily participate in this study (sign a written informed consent form).
Exclusion criteria
Exclusion criteria: (2) Exclusion criteria: If the answer to any of the following statements is "yes", it is excluded from the group. 1) Meets the DSM-5 diagnostic criteria for mental disorders other than severe depressive episodes; 2) Have a history of neurological disorders or serious physical illnesses (such as thyroid disease, lupus erythematosus, etc.) Diabetes, lung, liver and kidney damage, major trauma, etc.); 3) Individuals with a history of coma due to traumatic brain injury or other diseases that may interfere with this study; 4) Having a history of alcohol or drug abuse or dependence; 5) Or individuals with severe suicidal ideation or attempted suicide; 6) Currently, there are acute infections, autoimmune or inflammatory diseases, and other causes of inflammation in the body Physical diseases with significantly elevated levels; 7) Individuals taking warfarin or undergoing hormone therapy; 8) Take anti-inflammatory drugs for at least one week within the past month (allowing the combination of low-dose benzodiazepines) Zhuo class drugs; 9) Has received tetracycline treatment within the past two months, or has a history of allergies to tetracycline drugs, or Unable to tolerate its adverse reactions; 10) There are implanted metal materials in the body, such as pacemakers, dentures, metal contraceptive rings, etc; 11) Received ECT, rTMS, and DBS treatment in the past six months; 12) Pregnant and lactating female patients; 13) Basic laboratory tests and examinations (blood routine, liver and kidney function, thyroid function, electrocardiogram) before enrollment are present Abnormal: Blood routine indicates moderate or above anemia, or platelet count<80000; Liver function test conversion Those whose ammonia enzymes (ALT and AST) are 2 times or more higher than the upper limit of the normal range; The three indicators of thyroid function indicate the presence of hyperthyroidism Or hypothyroidism; The electrocardiogram indicates that the QTc of males is = 430 ms, while that of females is = 450 ms, or there is a presence of Mild or severe arrhythmia, etc. Blood pressure measurement: systolic/diastolic blood pressure = 85/55mmHg or = 150/95mmHg; Heart rate measurement: Heart rate = 45 beats/min or = 100 beats/min); 14) Other situations that the researcher believes may affect the research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery Asberg Depression Rating Scale, MADRS;Hamilton Depression Scale;SV2A BPND; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Emergent Symptom Scale,TESS;16-item Quick Inventory of Depressive Symptomatology-Self-Report;Generalized Anxiety Disorder, GAD-7;Hamilton Anxiety Rating Scale, HAMA;Snaith-Hamilton Pleasure Scale, SHAPS;Beck suicide inventory, BSI;Childhood trauma questionnaire, CTQ; | — |
Countries
China
Contacts
The Second Xiangya Hospital of Central South University