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

NCT ID: NCT05529576

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-23
• Study Completion Date: 2023-12-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Omega 3 fatty acid

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Omega 3 fatty acid

Intervention Type: DRUG

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Omega 3 fatty acid

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

Intervention Type: DRUG

Other Intervention Names

Ω-3 fatty acids

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qingdao Mental Health Center

UNKNOWN

Sponsor Role: collaborator

Harbin Medical University

OTHER

Sponsor Role: collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Chen, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center(SMHC)

Locations

Shanghai Mental Health Center IRB

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Chen, M.D.,Ph.D

Role: CONTACT

478030003@qq.com

021-34773528

Facility Contacts

Jun Chen, M.D., Ph.D

Role: primary

doctorcj2010@gmail.com

021-34773367

Other Identifiers

20220822

Identifier Type: -

Identifier Source: org_study_id