PKC as Serum Biomarkers for Depression

Sponsor
Shanghai Mental Health Center
Study ID
NCT04531423
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • SSRI + golimumab — DRUG
    Golimumab will be administered at the dose of 50mg every month during the acute phase.
  • SSRI + placebo — OTHER
    placebo

Study Details

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.

Key Dates

Start date
Oct 1, 2020
Status verified
Aug 2020
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SSRI + golimumab
    Participants will be administered with SSRI+golimumab . Golimumab will be administered at the dose of 50mg every month during the acute phase.
  • Active Comparator: SSRI +placebo
    Participants will be administered with SSRI+placebo

Primary Outcome Measure

remission of acute phase [ Time Frame: 12 weeks ]

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