Major Depressive DisorderPhase 4NCT05529576
Multi-factor Model Constraction for Early Warning and Diagnosis of MDD
A Phase 4 study testing Omega 3 fatty acid in people with Major Depressive Disorder and Bipolar Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder, Omega-3 Fatty Acids
- What is being tested?
- Omega 3 fatty acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2022to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have any contraindications to Ω-3 fatty acids
- Severe physical disease
- Diagnosed with schizophrenia, or other mental illness spectra
- Have received physical therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center IRB
Shanghai, Shanghai Municipality, 200030
Jun Chen, M.D., Ph.D, 021-34773367, doctorcj2010@gmail.com
About this study
Official title: 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
Read the 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.
- Being tested
- Omega 3 fatty acid
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 fatty acidDrug
Also called Ω-3 fatty acids
Omega-3 fatty acids complementation according to the patient's CRP level
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start23 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Qingdao No. 7 People's Hospital, Harbin Medical University
- Responsible party
- Sponsor
- Investigators
- Jun Chen, M.D.,Ph.D, Principal investigator, Shanghai Mental Health Center(SMHC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529576
- Sponsor's protocol ID
- 20220822
- Status last verified
- Aug 2022
- First submitted
- 1 Sep 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-factor Model Constraction for Early Warning and Diagnosis of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05529576
- Acronym / sponsor ID
- 20220822
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Qingdao No. 7 People's Hospital, Harbin Medical University
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Major depressive disorder | Experimental | Drug: Omega 3 fatty acidOutpatients 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. |
| Bipolar disorder | Active comparator | Drug: Omega 3 fatty acidOutpatients 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 | 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Have any contraindications to Ω-3 fatty acids
- Severe physical disease
- Diagnosed with schizophrenia, or other mental illness spectra
- Have received physical therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 fatty acidAlso: Ω-3 fatty acidsOmega-3 fatty acids complementation according to the patient's CRP level | Drug | Bipolar disorder, Major depressive disorder |
Primary outcome
Depressive symptoms assessed by HAMD-17
Time frame: up to 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Chen, M.D.,Ph.D principal investigator
Shanghai Mental Health Center(SMHC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega 3 fatty acid in people with Major Depressive Disorder and Bipolar Disorder, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Chen, M.D.,Ph.D (021-34773528, 478030003@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms assessed by HAMD-17 (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.