PKC as Serum Biomarkers for Depression

This is an interventional treatment trial for Major Depressive Disorder Read More

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