PAID study design on the role of PKC activation in immune/inflammation-related depression: a randomised placebo-controlled trial protocol

Autor: Jun Chen, Fan Wang, Xiaoyun Guo, Zezhi Li, Yiru Fang, Jia Huang, Ruizhi Mao, Lvchun Cui, Rubai Zhou, Yuncheng Zhu, Yamin Yao, Guoqing Zhao, Jinhui Wang
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: General Psychiatry, Vol 34, Iss 2 (2021)
Druh dokumentu: article
ISSN: 2517-729X
40076121
DOI: 10.1136/gpsych-2020-100440
Popis: Background 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. We assume that the abnormality in PKC might result in abnormal microglia activation, neuronal apoptosis, significant changes in emotional and cognitive neural circuits, and TRD. In the current study, we plan to target at the PKC signal pathway to improve the TRD treatment outcome.Methods and analysis This is a 12-week, ongoing, randomised, placebo-controlled trial. Patients with TRD (N=180) were recruited from Shanghai Mental Health Center, Shanghai Jiao Tong University. Healthy control volunteers (N=60) were recruited by advertisement. Patients with TRD were randomly assigned to ‘escitalopram+golimumab (TNF-α inhibitor)’, ‘escitalopram+calcium tablet+vitamin D (PKC activator)’ or ‘escitalopram+placebo’ groups. We define the primary outcome as changes in the 17-item Hamilton Depression Rating Scale (HAMD-17). The secondary outcome is defined as changes in anti-inflammatory effects, cognitive function and quality of life.Discussion This study might be the first randomised, placebo-controlled trial to target at the PKC signal pathway in patients with TRD. Our study might help to propose individualised treatment strategies for depression.Trial registration number The trial protocol is registered with ClinicalTrials.gov under protocol ID 81930033 and ClinicalTrials.gov ID NCT04156425.
Databáze: Directory of Open Access Journals
Externí odkaz: