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

April 1, 2019 updated by: Yiru FANG M.D., Ph.D., Shanghai Mental Health Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:
        • Principal Investigator:
          • Yiru Fang, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
remission of acute phase
Time Frame: 12th week
scored 7 or lower on the Hamilton's Depression Scale with 17 items
12th week
remission of consolidate and maintenance phase
Time Frame: 12th month
scored 7 or lower on the Hamilton's Depression Scale with 17 items
12th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Investigators

  • Study Chair: Yiru Fang Fang, MD. PhD., Shanghai Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81771465

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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