PKC as Serum Biomarkers for Depression

Major Depressive Disorder Clinical Trial

Official title:

PKC as Serum Biomarkers for Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04531423
• Other study ID #: smhcgxy
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2020
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (1:1) into one of the following 2groups: "SSRI +golimumab"," or "SSRI +placebo". The total study duration is 12 weeks

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Diagnosed with major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);

• Insufficient response (response rate <50%) to two antidepressants with different mechanisms when given for at least 6 weeks at an adequate dose (e.g., clomipramine =150 mg/d, fluoxetine=20 mg/d) during the current episode;

• A 17-item Hamilton Depression Rating Scale (HAMD-17) score = 17 no more than 7 days prior to randomization. Cognitive factors (including a sense of guilt, suicidal thoughts, agitation, depersonalization, the disintegration of reality, paranoid symptoms, and obsessive and compulsive symptoms) score =6; ? Between 18 and 65 years of age;

? Education: finished junior middle school;

? Ethnicity: Han Chinese;

• Adequate audio and visual levels to complete the necessary checks; ? Compliance with treatment in the clinical trial.

Exclusion Criteria:

• Severe liver and kidney diseases, active endocrine diseases or clinical symptoms. Severe cardiovascular disease, respiratory system disease, hematologic diseases and cancer.

• Serious suicide attempts.

• Pregnancy or lactation.

• Modified electroconvulsive therapy (MECT) therapy in the past 1 month. ? Known current psychosis as determined by the DSM-5 or a history of a non-mood psychotic disorder.

• Participation in another clinical trial concurrently or no more than 1 month prior to randomization.

• Previously had a severe allergic reaction or immune system disease; ? Using an anti-inflammatory drug or immunosuppressive agent; ? HAMD-17 item 3 (suicide) score: =3

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• SSRI + golimumab
Golimumab will be administered at the dose of 50mg every month during the acute phase.

Other:
• SSRI + placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remission of acute phase	The primary outcome is defined as changes in HAMD-17 between baseline and 12weeks scored 7 or lower on the Hamilton's Depression Scale with 17 items	12 weeks