NCT05529576

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_4 major-depressive-disorder

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_4 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 7, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

September 1, 2022

Last Update Submit

September 5, 2022

Conditions

Major Depressive DisorderBipolar DisorderOmega-3 Fatty Acids

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Major depressive disorder

EXPERIMENTAL

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

Bipolar disorder

ACTIVE COMPARATOR

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

Healthy controls

NO INTERVENTION

Healthy controls in main-center and sub-centers; no history of psychiatric disease; age between 18-65 years old; gender is not limited.

Interventions

Omega 3 fatty acidDRUG

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

Also known as: Ω-3 fatty acids
Bipolar disorderMajor depressive disorder

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center IRB

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, MajorBipolar Disorder

Interventions

Fatty Acids, Omega-3Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Jun Chen, M.D.,Ph.D

    Shanghai Mental Health Center(SMHC)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Chen, M.D.,Ph.D

CONTACT

021-34773528478030003@qq.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 7, 2022

Study Start

August 23, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 7, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)