NCT05529576

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Major Depressive Disorder
• Bipolar Disorder
• Omega-3 Fatty Acids

Interventions

Type	Name	Description
DRUG	Omega 3 fatty acid	Omega-3 fatty acids complementation according to the patient's CRP level

Timeline

• Start date: 2022-08-23
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-09-07
• Last updated: 2022-09-07

Locations

1 site across 1 country: China