Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Role of PKC Activation in the Immune-inflammatory Mechanism of Major Depressive Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04156425
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Mental Health Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Escitalopram+golimumab Dietary Supplement: Escitalopram+Calcium Tablet Drug: Escitalopram Not Applicable

Detailed Description:
This is a randomized, double blind, placebo-controlled antidepressant augmentation trial. All participants are randomly divided into 3 groups treated orally with "escitalopram + golimumab" (N = 60), "escitalopram + calcium tablet" (N = 60) or "escitalopram +placebo" (N = 60).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: group1:escitalopram + golimumab (N = 60), group2:escitalopram + calcium tablet (N = 60) group3:escitalopram +placebo (N = 60).
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of PKC Activation in the Immune-inflammatory Mechanism of Major Depressive Depression
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: escitalopram + golimumab
Patients will be treated with escitalopram from the minimum dosage and golimumab according to direction for use.
Drug: Escitalopram+golimumab
Escitalopram will be administered at 10-20 mg/d during the acute phase. Golimumab will be administered at the dose of 50mg every month during the acute phase.
Other Name: Lexapro+Simponi

Experimental: escitalopram + calcium tablet
Patients will be treated with escitalopram from the minimum dosage and calcium tablet according to direction for use.
Dietary Supplement: Escitalopram+Calcium Tablet
Escitalopram will be administered at 10-20 mg/d during the acute phase. Calcium tablet will be administered at 2000mg/d during the acute phase.
Other Name: Lexapro+Caltrate

Active Comparator: escitalopram
Patients will be treated with escitalopram from the minimum dosage.
Drug: Escitalopram
Escitalopram will be administered at 10-20 mg/d during the acute phase.
Other Name: Lexapro




Primary Outcome Measures :
  1. remission of acute phase [ Time Frame: 12th week ]
    scored 7 or lower on the Hamilton's Depression Scale with 17 items



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy men or women of matched age, gender and education with that of treatment-resistant depression (TRD) group;
  2. A willingness to adhere to all prohibitions and restrictions necessary for the study;
  3. Signed informed consent.

Exclusion Criteria:

  1. Participant who have severe mental diseases, physical diseases, cerebrovascular disease, or a history of traumatic brain injury;
  2. Participant who had a serious allergic reaction disease or those who have suffered from diseases of the immune system;
  3. Participant who used anti-inflammatory drugs, or immunomodulatory drugs no more than 1 month prior randomization;
  4. Pregnant or lactating female.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156425


Contacts
Layout table for location contacts
Contact: Yiru Fang, MD. PhD. 021-64387250 yirufang@aliyun.com
Contact: Yiru Fang, MD. PhD. (86) 18017311133 yirufang@gmail.com

Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
Layout table for investigator information
Study Chair: Yiru Fang Shanghai Mental Health Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT04156425    
Other Study ID Numbers: 81930033
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Mental Health Center:
Major Depressive Disorder
neuroimmunology
Protein Kinase C
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents