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NCT04156425
The Role of PKC Activation in the Immune-inflammatory Mechanism of Major Depressive Depression
NA trial testing Escitalopram+golimumab in Major Depressive Disorder in 180 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | Shanghai Mental Health Center |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 1 July 2020 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
Drugs / interventions tested
- Escitalopram+golimumab — full drug profile →
- Escitalopram+Calcium Tablet
- Escitalopram (escitalopram) — full drug profile →
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
Shanghai Mental Health Center — full company profile →
Who can join
Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
PAID study design on the role of PKC activation in immune/inflammation-related depression: a randomised placebo-controlled trial protocol.
Guo X, Mao R, Cui L, Wang F, et al · · 2021 · cited 6× · PMID 33912799 · DOI 10.1136/gpsych-2020-100440
Verify or expand the search:
- PubMed search for NCT04156425
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04156425 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Mental Health Center
- Last refreshed: 12 May 2020
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