PKC as Serum Biomarkers for Depression

NCT04531423 | Unknown

• 1 other identifier: smhcgxy
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SSRI + golimumab

EXPERIMENTAL

Participants will be administered with SSRI+golimumab . Golimumab will be administered at the dose of 50mg every month during the acute phase.

Drug: SSRI + golimumab

SSRI +placebo

ACTIVE COMPARATOR

Participants will be administered with SSRI+placebo

Other: SSRI + placebo

Interventions

SSRI + golimumab DRUG

Golimumab will be administered at the dose of 50mg every month during the acute phase.

SSRI + golimumab

SSRI + placebo OTHER

placebo

SSRI +placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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; ④ Between 18 and 65 years of age;
• ⑤ Education: finished junior middle school;
• ⑥ Ethnicity: Han Chinese;
• Adequate audio and visual levels to complete the necessary checks; ⑧ Compliance with treatment in the clinical trial.

You may not qualify if:

• 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. ⑤ 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; ⑧ Using an anti-inflammatory drug or immunosuppressive agent; ⑨ HAMD-17 item 3 (suicide) score: ≥3

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Selective Serotonin Reuptake Inhibitors; golimumab

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators adopted randomized design to test placebo-controlled antidepressant augmentation.Participants were randomized (1:1) into one of the following 2 groups: "SSRI +golimumab"," or "SSRI +placebo".

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 28, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share