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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04156425
Other study ID # 81930033
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date December 31, 2024

Study information

Verified date October 2019
Source Shanghai Mental Health Center
Contact Yiru Fang, MD. PhD.
Phone 021-64387250
Email yirufang@aliyun.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 180
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Intervention

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.
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.
Drug:
Escitalopram
Escitalopram will be administered at 10-20 mg/d during the acute phase.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Mental Health Center

Outcome

Type Measure Description Time frame Safety issue
Primary remission of acute phase scored 7 or lower on the Hamilton's Depression Scale with 17 items 12th week
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