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

Sponsor

Shanghai Mental Health Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03899194

Collaborator

(none)

350

Enrollment

Location

Arms

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

group 1: escitalopram group 2: escitalopram + Omega-3 PUFAsgroup 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 :

Jan 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

remission of acute phase [12th week]
scored 7 or lower on the Hamilton's Depression Scale with 17 items
remission of consolidate and maintenance phase [12th month]
scored 7 or lower on the Hamilton's Depression Scale with 17 items

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria for patients:

Drug-naive or medication free for no less than 4 weeks;
18-60 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.