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.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: December 31, 2024
This is a randomized, double blind, placebo-controlled antidepressant augmentation trial. All participants are randomly divided into 3 groups treated orally with "escitalopram + golimumab" (N = 60), "escitalopram + calcium tablet" (N = 60) or "escitalopram +placebo" (N = 60).
- Drug: Escitalopram+golimumab
- 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.
- Dietary Supplement: Escitalopram+Calcium Tablet
- 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.
- Drug: Escitalopram
- Escitalopram will be administered at 10-20 mg/d during the acute phase.
Arms, Groups and Cohorts
- 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.
Clinical Trial Outcome Measures
- remission of acute phase
- Time Frame: 12th week
- scored 7 or lower on the Hamilton’s Depression Scale with 17 items
Participating in This Clinical Trial
1. Healthy men or women of matched age, gender and education with that of treatment-resistant depression (TRD) group;
2. A willingness to adhere to all prohibitions and restrictions necessary for the study;
3. Signed informed consent.
1. Participant who have severe mental diseases, physical diseases, cerebrovascular disease, or a history of traumatic brain injury;
2. Participant who had a serious allergic reaction disease or those who have suffered from diseases of the immune system;
3. Participant who used anti-inflammatory drugs, or immunomodulatory drugs no more than 1 month prior randomization;
4. Pregnant or lactating female.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Shanghai Mental Health Center
- Provider of Information About this Clinical Study
- Overall Official(s)
- Yiru Fang, Study Chair, Shanghai Mental Health Center
- Overall Contact(s)
- Yiru Fang, MD. PhD., 021-64387250, firstname.lastname@example.org
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