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

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

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

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder; Major Depressive Disorder; Omega-3 Fatty Acids
• Intervention / Treatment: Drug: Omega 3 fatty acid

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jun Chen, M.D.,Ph.D; Phone Number: 021-34773528; Email: 478030003@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Mental Health Center IRB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Major depressive disorder; 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.	Drug: Omega 3 fatty acid; Omega-3 fatty acids complementation according to the patient's CRP level; Other Names: Ω-3 fatty acids
ACTIVE_COMPARATOR: Bipolar disorder; 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	Drug: Omega 3 fatty acid; Omega-3 fatty acids complementation according to the patient's CRP level; Other Names: Ω-3 fatty acids
NO_INTERVENTION: Healthy controls; Healthy controls in main-center and sub-centers; no history of psychiatric disease; age between 18-65 years old; gender is not limited.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Collaborators: Harbin Medical University; Qingdao Mental Health Center
• Investigators: Principal Investigator: Jun Chen, M.D.,Ph.D, Shanghai Mental Health Center(SMHC)

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 23, 2022
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (ACTUAL): September 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Disease; Bipolar Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 20220822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No