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

Primary Purpose

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

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Omega 3 fatty acid
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shanghai Mental Health Center IRBRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Major depressive disorder

Bipolar disorder

Healthy controls

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2022
Last Updated
September 5, 2022
Sponsor
Shanghai Mental Health Center
Collaborators
Qingdao Mental Health Center, Harbin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05529576
Brief Title
Multi-factor Model Constraction for Early Warning and Diagnosis of MDD
Official Title
Multi-factor Model Constraction for Early Warning and Diagnosis of Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Qingdao Mental Health Center, Harbin Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. 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 We will give omega-fatty acid treatment based on immune indicators The follow-up will last for one year with five sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Bipolar Disorder, Omega-3 Fatty Acids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Major depressive disorder
Arm Type
Experimental
Arm Description
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.
Arm Title
Bipolar disorder
Arm Type
Active Comparator
Arm Description
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
Arm Title
Healthy controls
Arm Type
No Intervention
Arm Description
Healthy controls in main-center and sub-centers; no history of psychiatric disease; age between 18-65 years old; gender is not limited.
Intervention Type
Drug
Intervention Name(s)
Omega 3 fatty acid
Other Intervention Name(s)
Ω-3 fatty acids
Intervention Description
Omega-3 fatty acids complementation according to the patient's CRP level
Primary Outcome Measure Information:
Title
Depressive symptoms assessed by HAMD-17
Description
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.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Chen, M.D.,Ph.D
Phone
021-34773528
Email
478030003@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Chen, M.D.,Ph.D
Organizational Affiliation
Shanghai Mental Health Center(SMHC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center IRB
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Chen, M.D., Ph.D
Phone
021-34773367
Email
doctorcj2010@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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