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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05529576
Enrollment
600
Registered
2022-09-07
Start date
2022-08-23
Completion date
2023-12-31
Last updated
2022-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGOmega 3 fatty acid

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

Sponsors

Qingdao Mental Health Center
CollaboratorUNKNOWN
Harbin Medical University
CollaboratorOTHER
Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Depressive symptoms assessed by HAMD-17up to 12 monthsDepressive 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.

Countries

China

Contacts

Primary ContactJun Chen, M.D.,Ph.D
478030003@qq.com021-34773528

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026