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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05529576
Other study ID # 20220822
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 23, 2022
Est. completion date December 31, 2023

Study information

Verified date August 2022
Source Shanghai Mental Health Center
Contact Jun Chen, M.D.,Ph.D
Phone 021-34773528
Email 478030003@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Current research on the pathogenesis of depression shows that imbalanced inflammatory factors are closely related to Major Depressive Disorder(MDD). As reported, physical exercise, Ω-3 fatty acids, and sulforaphane can be complementary therapies for moderate-to-severe depression. In addition, imaging studies have found changes in the structure and functional connectivity of the brain. Therefore, this study intends to collect clinical and biological information from patients with depression and healthy controls to establish a multi-factor model for early warning and diagnosis of major depressive disorder


Description:

The immune imbalance has been reported in patients with unipolar and bipolar depression. There is no unified conclusion in the field and severity of the immune imbalance, and the cause of cognitive impairment is unknown, which may be related to many factors. Omega-3 fatty acids are immune modulators that possess antidepressant effects. This study includes three steps. 1. We will enroll bipolar and major depressive disorder patients who are in a depressive episode and enroll healthy controls. All subjects will be assessed at baseline 2. We will give omega-fatty acid treatment based on immune indicators 3. The follow-up will last for one year with five sessions.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Outpatients in main-center and sub-centers - Age between 18-65 years old - Meet the DSM-IV diagnosis of depressive episode - HAMD-17 score>17 at baseline - No antidepressant treatment within 6 weeks prior to enrollment - Adequate cognition level to complete the tests necessary for the study - Willing to sign the informed consent form Exclusion Criteria: - Have any contraindications to O-3 fatty acids - Severe physical disease - Diagnosed with schizophrenia, or other mental illness spectra - Have received physical therapy

Study Design


Intervention

Drug:
Omega 3 fatty acid
Omega-3 fatty acids complementation according to the patient's CRP level

Locations

Country Name City State
China Shanghai Mental Health Center IRB Shanghai Shanghai

Sponsors (3)

Lead Sponsor Collaborator
Shanghai Mental Health Center Harbin Medical University, Qingdao Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depressive symptoms assessed by HAMD-17 Depressive symptoms are the primary outcome, and we will use HAMD-17 to examine depressive symptoms.
Respones: a reduction of 50% or more in baseline scores.Remission:HAMD?7.
up to 12 months
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