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Study on the Effect of PRKCB1 Modulating Inflammatory Factors and the Role for Developing Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03899194
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Yiru FANG M.D., Ph.D., Shanghai Mental Health Center

Brief Summary:
Depressive disorder is known as being accompanied with the activation of immune system which could lead to a series of changes including the neuron apoptosis, synapses transmission inhibition and emotional symptoms. The activation of protein kinase C (PKC) can reverse the immune/inflammatory process and restore the neuroplasticity and neurotransmitters transmission. Based on our finding that patients with major depressive disorder (MDD) showed a significantly lower gene expression of PRKCB1, while the PKC activation mediated by PRKCB1, we hypothesize that PRKCB1 contribute to the development of MDD and treatment response by its specific expression in brain, regulating ERBB, Chemokine signaling pathways and PKC activation during the neuroinflammatory process. In the present study, we aim to evaluate and verify the regulation effect of PRKCB1 on the neuroimmune and inflammatory mechanism in depressive disorder by a serious of studies focus on PRKCB1 gene expression modulating process and different downstream biomarkers which associated with PRKCB1 effect, combined with the specified treatment (plus omega-3 poly unsaturated fat acids). This study may provide scientific evidences for using neuroinflammatory biomarkers to diagnose MDD, as well as personalized treatment.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Dietary Supplement: fish oil capsules Drug: escitalopram Not Applicable

Detailed Description:

(1)To find out the differences of expression of mRNA, lncRNA, miRNA and proteins of PRKCB1 between patients with depressive disorder and healthy subjects.

(2) Patients with depressive disorders will be randomized into two groups that they will be treated with escitalopram or escitalopram plus Omega-3 PUFAs. To observe the effects of Omega-3 PUFAs on PRKCB1 and related neuroimmune/neuroinflammatory pathway which may improve understanding the relationship between neuroinflammatory regulation and depressive disorder treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: group 1: escitalopram group 2: escitalopram + Omega-3 PUFAs
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on the Effect of PRKCB1 Modulating Inflammatory Factors and the Role for Developing Major Depressive Disorder
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: escitalopram
Patients will only be treated with escitalopram from the minimum dosage.
Drug: escitalopram
escitalopram 10-20 mg/d

Experimental: escitalopram+ fish oil capsules
Patients will be treated with escitalopram from the minimum dosage and fish oil capsules according to direction for use.
Dietary Supplement: fish oil capsules
fish oil capsules(1000mg,EPA 180mg;DHA 120mg)




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

  2. remission of consolidate and maintenance phase [ Time Frame: 12th month ]
    scored 7 or lower on the Hamilton's Depression Scale with 17 items



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for patients:

  1. Drug-naive or medication free for no less than 4 weeks;
  2. 18-60 years old, Han nationality;
  3. Junior high school diploma or above;
  4. Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-TR;
  5. Scored 17 or higher on the Hamilton's Depression Scale with 17 items (HAMD-17) and scored 2 or higher for the 2nd item (depressive mood);
  6. Written informed consent has been obtained.

Exclusion Criteria for patients:

  1. Concurring psychotic disorders;
  2. Woman who is pregnant or breast feeding or is planning to get pregnant;
  3. Scores 3 or higher on item 3 (suicidal) of HAMD-17;
  4. serious allergy or disease of immune system;
  5. had anti-inflammatory drug or immunosuppressant in the past 1 month;
  6. serious medical or surgical illness or history;
  7. had MECT in the past 1 month.

Eligibility Criteria for healthy volunteers:

  1. match the patient group in age, gender, education and handedness;
  2. no history of psychiatric disorders or debilitating general medical disorders.

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): NCT03899194


Contacts
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Contact: Yiru Fang, MD. PhD. 021-64387250 yirufang@aliyun.com

Locations
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China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Yiru Fang, M.D., Ph.D.    (86) 18017311133    yirufang@gmail.com   
Principal Investigator: Yiru Fang, M.D., Ph.D.         
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
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Study Chair: Yiru Fang Fang, MD. PhD. Shanghai Mental Health Center

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Responsible Party: Yiru FANG M.D., Ph.D., Director, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03899194     History of Changes
Other Study ID Numbers: 81771465
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yiru FANG M.D., Ph.D., Shanghai Mental Health Center:
major depressive disorder
neuroimmunology
PRKCB1 gene
modulation
biomarker

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
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