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

NCT03899194 | Unknown

• 1 other identifier: 81771465
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

major depressive disorder; neuroimmunology; PRKCB1 gene; modulation; biomarker

Outcome Measures

Primary Outcomes (2)

• remission of acute phase

  scored 7 or lower on the Hamilton's Depression Scale with 17 items

  12th week

• remission of consolidate and maintenance phase

  scored 7 or lower on the Hamilton's Depression Scale with 17 items

  12th month

Study Arms (2)

escitalopram

ACTIVE COMPARATOR

Patients will only be treated with escitalopram from the minimum dosage.

Drug: escitalopram

escitalopram+ fish oil capsules

EXPERIMENTAL

Patients will be treated with escitalopram from the minimum dosage and fish oil capsules according to direction for use.

Dietary Supplement: fish oil capsules

Interventions

fish oil capsules DIETARY_SUPPLEMENT

fish oil capsules(1000mg，EPA 180mg；DHA 120mg)

escitalopram+ fish oil capsules

escitalopram DRUG

escitalopram 10-20 mg/d

escitalopram

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Drug-naive or medication free for no less than 4 weeks;
• years old, Han nationality;
• Junior high school diploma or above;
• Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-TR;
• 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);
• Written informed consent has been obtained.

You may not qualify if:

• Concurring psychotic disorders;
• Woman who is pregnant or breast feeding or is planning to get pregnant;
• Scores 3 or higher on item 3 (suicidal) of HAMD-17;
• serious allergy or disease of immune system;
• had anti-inflammatory drug or immunosuppressant in the past 1 month;
• serious medical or surgical illness or history;
• had MECT in the past 1 month.
• Eligibility Criteria for healthy volunteers:
• match the patient group in age, gender, education and handedness;
• no history of psychiatric disorders or debilitating general medical disorders.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (1)

• Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.

  PMID: 34817851 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Fish Oils; Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oils; Lipids; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yiru Fang Fang, MD. PhD.

  Shanghai Mental Health Center

  STUDY CHAIR

Central Study Contacts

Yiru Fang, MD. PhD.

CONTACT

021-64387250; yirufang@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: group 1: escitalopram group 2: escitalopram + Omega-3 PUFAs

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: April 2, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 2, 2019

Record last verified: 2019-04

Locations

CN (1)