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A study on the mechanism of neuroinflammation involved in the treatment resistance to SSRIs/SNRIs in patients with major depressive disorder and a history of childhood trauma

A study on the mechanism of neuroinflammation involved in the treatment resistance to SSRIs/SNRIs in patients with major depressive disorder and a history of childhood trauma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086345
Enrollment
Unknown
Registered
2024-06-28
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Interventions

Experimental group:The minocycline group is treated with minocycline hydrochloride capsules for 8 weeks on the basis of original SSRIs or SNRIs treatment, with a treatment dose of 100mg/bid.
Control group:The control group still maintains the original SSRIs or SNRIs treatment, and the medication should not be adjusted as much as possible during the observation period

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 30 Years

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

MeasureTime frame
Montgomery Asberg Depression Rating Scale, MADRS;Hamilton Depression Scale;SV2A BPND;

Secondary

MeasureTime 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

Public ContactLiu Jin

The Second Xiangya Hospital of Central South University

liujin975@csu.edu.cn+86 131 2339 2823

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026