The Role of PKC Activation in the Immune-inflammatory Mechanism of Major Depressive Depression

Sponsor
Shanghai Mental Health Center
Study ID
NCT04156425
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Escitalopram+golimumab — DRUG
    Escitalopram will be administered at 10-20 mg/d during the acute phase. Golimumab will be administered at the dose of 50mg every month during the acute phase.
  • Escitalopram+Calcium Tablet — DIETARY_SUPPLEMENT
    Escitalopram will be administered at 10-20 mg/d during the acute phase. Calcium tablet will be administered at 2000mg/d during the acute phase.
  • Escitalopram — DRUG
    Escitalopram will be administered at 10-20 mg/d during the acute phase.

Study Details

Major Depressive disorder (MDD) is a heterogeneous mental illness. Treated with antidepressants that act on the neurotransmitter and/or their receptors just remitted only one third of patients with MDD, Thus, to improve the efficacy is a major unmet need for depression. Based on the scientific reports, inflammation plays a definite role in the development and treatment of depression, which may be an important way to understand and finally solve the problem. Our team found that there were significant changes in tumor necrosis factor (TNF)-α and other inflammatory factors in depressed patients, which caused neuronal apoptosis and depressive symptoms; PRKCB1(gene of protein kinase C-β) plays an anti-inflammatory role by regulating protein kinase C(PKC) activation in specific brain region, improving neuroplasticity and playing an antidepressant role. In this study, we assumes that the treatment-resistant depression patients maybe due to the immune inflammation and PKC activation inconsistency or unsynchronized, which couldn't reversible microglia polarization and neuronal apoptosis in specific brain regions, then, caused the significant changes at emotional and cognitive neural circuits, so as to exhibit such as emotional, cognitive symptoms of depression. Therefore, activating PKC and regulating immune/inflammatory process will be another way to improve the treatment outcome of depression. Take consideration, we focus on treatment-resistant depression patients, to validate the relationship between PKC activation and the immune inflammatory mechanism of depression, evaluate the antidepressant effect of golimumab or calcium tablet (a PKC activator) plus escitalopram, and initially proposes idividualized treatment strategies for MDD.

Key Dates

Start date
Jul 1, 2020
Status verified
Oct 2019
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: escitalopram + golimumab
    Patients will be treated with escitalopram from the minimum dosage and golimumab according to direction for use.
  • Experimental: escitalopram + calcium tablet
    Patients will be treated with escitalopram from the minimum dosage and calcium tablet according to direction for use.
  • Active Comparator: escitalopram
    Patients will be treated with escitalopram from the minimum dosage.

Primary Outcome Measure

remission of acute phase [ Time Frame: 12th week ]

Central Contacts

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