Multi-factor Model Constraction for Early Warning and Diagnosis of MDD

Major Depressive Disorder Clinical Trial

Official title:

Multi-factor Model Constraction for Early Warning and Diagnosis of Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05529576
• Other study ID #: 20220822
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Omega-3 Fatty Acids

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