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

Phase 4

• Conditions: Major Depressive Disorder; Omega-3 Fatty Acids; Bipolar Disorder
• Interventions: Drug: Omega 3 fatty acid

• Registration Number: NCT05529576
• Lead Sponsor: Shanghai Mental Health Center

Brief 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.

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-08-23
• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-05
• Last Update Submitted: 2022-09-05
• Study First Posted: 2022-09-07
• Last Update Posted: 2022-09-07
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 Ω-3 fatty acids
• Severe physical disease
• Diagnosed with schizophrenia, or other mental illness spectra
• Have received physical therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Major depressive disorder	Omega 3 fatty acid	Outpatients in main-center and sub-centers; meet the DSM-IV diagnosis of Major Depressive Disorder (mental examination was conducted by at least two professional doctors); available relevant HIS system biochemical data; haven't been treated with physical therapy; age between 18-65 years old; gender is not limited.
Bipolar disorder	Omega 3 fatty acid	Outpatients in main-center and sub-centers; meet the DSM-IV diagnosis of Bipolar disorder (mental examination was conducted by at least two professional doctors); available relevant HIS system biochemical data; haven't been treated with physical therapy; age between 18-65 years old; gender is not limited

Primary Outcome Measures

Name	Time	Method
Depressive symptoms assessed by HAMD-17	up to 12 months	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.

Trial Locations

Locations (1)

Shanghai Mental Health Center IRB; 🇨🇳 Shanghai, Shanghai, China