PKC as Serum Biomarkers for Depression

• Status: Not yet recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Inflammation that is mediated by microglia activation plays an important role in the pathogenesis of depression. Microglia activation can lead to an increase in the levels of proinflammatory cytokines, including TNF-α, which leads to neuronal apoptosis in the specific neural circuits of some brain regions, abnormal cognition, and treatment-resistant depression (TRD). Protein kinase C (PKC) is a key regulator of the microglia activation process. The investigators assume that the abnormality in PKC might be the serum biomarkers of depression.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Mental Health Center
• Treatments: Golimumab

Criteria

Inclusion Criteria:

• Diagnosed with major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);

• Insufficient response (response rate <50%) to two antidepressants with different mechanisms when given for at least 6 weeks at an adequate dose (e.g., clomipramine ≥150 mg/d, fluoxetine≥20 mg/d) during the current episode;

• A 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥ 17 no more than 7 days prior to randomization. Cognitive factors (including a sense of guilt, suicidal thoughts, agitation, depersonalization, the disintegration of reality, paranoid symptoms, and obsessive and compulsive symptoms) score ≥6; ④ Between 18 and 65 years of age;

⑤ Education: finished junior middle school;

⑥ Ethnicity: Han Chinese;

• Adequate audio and visual levels to complete the necessary checks; ⑧ Compliance with treatment in the clinical trial.

Exclusion Criteria:

• Severe liver and kidney diseases, active endocrine diseases or clinical symptoms. Severe cardiovascular disease, respiratory system disease, hematologic diseases and cancer.

• Serious suicide attempts.

• Pregnancy or lactation.

• Modified electroconvulsive therapy (MECT) therapy in the past 1 month. ⑤ Known current psychosis as determined by the DSM-5 or a history of a non-mood psychotic disorder.

• Participation in another clinical trial concurrently or no more than 1 month prior to randomization.

• Previously had a severe allergic reaction or immune system disease; ⑧ Using an anti-inflammatory drug or immunosuppressive agent; ⑨ HAMD-17 item 3 (suicide) score: ≥3