Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04531423
Status:
UNKNOWN
Last Update Posted:
2020-08-28
First Post:
2020-08-16
Brief Title:
PKC as Serum Biomarkers for Depression
Sponsor:
Shanghai Mental Health Center
Organization:
Shanghai Mental Health Center
Study Overview
Official Title:
PKC as Serum Biomarkers for Depression
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
PKC activation might reduce M1 microglia activation and the release of proinflammatory cytokines such as TNF-α finally alleviating depressive symptoms in TRD
Primary objective This study was designed to address the role of PKC-mediated microglial activation in the clinical outcome of first episode depression
Secondary objective To illustrate the impact of PKC-mediated microglial activation on impaired cognition social function and neuronal plasticity
The investigators adopted randomized design to test placebo-controlled antidepressant augmentation Patients were randomized 11 into one of the following 2groups SSRI golimumab or SSRI placebo The total study duration is 12 weeks
Primary objective This study was designed to address the role of PKC-mediated microglial activation in the clinical outcome of first episode depression
Secondary objective To illustrate the impact of PKC-mediated microglial activation on impaired cognition social function and neuronal plasticity
The investigators adopted randomized design to test placebo-controlled antidepressant augmentation Patients were randomized 11 into one of the following 2groups SSRI golimumab or SSRI placebo The total study duration is 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None