Major Depressive DisorderNCT03295708
Fish Oil as Adjunct Treatment for Major Depressive Disorder
A study testing fish oil capsule and soybean oil capsule in people with Major Depressive Disorder, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
In this proposed study, the investigators will evaluate the effects of fish oil add-on in treatment of major depressive disorder(MDD). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- fish oil capsule and soybean oil capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 1 Apr 2020
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able to provide informed consent
- Men or women aged 18-50 years
- A primary psychiatric diagnosis of major depressive disorder (MDD), by Diagnostic and Statistical Manual-5th ed (DSM-5) using the MINI
- HAMD total score≥21
- No significantly modification of their diet from the time they sign consent to the end of study participation
Who cannot join
- Suffering from other serious somatic diseases or comorbidities
- Patients with serious nervous system disease
- Patients in accordance with diagnostic standards of other mental illness
- Patients who need to take benzodiazepine every day, and who currently need to be treated by electroconvulsive therapy or have received electroconvulsive therapy in the past 6 months
- Pregnant women or lactating women, women with pregnancy plans during the trial period (12 months), women with a high risk of pregnancy but without taking any contraceptive measures
- Patients with apparent suicide attempt or suicidal behavior
Show all 9Show fewer
- Any condition or medicines that may have an effect on biomarkers (within 1 week of the screening period or during whole trial period): long-term, regular use of NSAIDs, COX-2 inhibitors, immunosuppressant, steroids, interferon, chemotherapeutics, anticoagulants, malignancy, active autoimmune diseases, inflammatory bowel diseases, etc
- Allergy history of PUFA
- Intake of Fish oil more than 3g per day or eat fatty fish more than 3 times a week
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mental Health Institute, Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Lu Wang, M.D., +8615116331768, luwang112@163.com
Mi Mi Tang, M.D., +8617136372000, tangmimi1989@163.com
About this study
Official title: Safety, Effectiveness, and Mechanism of Fish Oil as Adjunct Treatment for Major Depressive Disorder - a 12-month Randomized, Placebo Controlled Clinical Trial
In this proposed study, the investigators will evaluate the effects of fish oil add-on in treatment of major depressive disorder(MDD).
Read the detailed description
Participants are randomly assigned to two groups (n=60): control (placebo, soybean) and fish oil (containing EPA 1440mg, DHA 960mg). The experimental groups will be compared to placebo to evaluate if it may benefit clinical symptoms, cognitive symptoms and metabolic markers in MDD patients. We also plan to investigate the changes in markers of inflammation at the same time.
- Conditions
- Major Depressive Disorder
- Being tested
- fish oil capsule, soybean oil capsule
- Keywords
- Major depressive disorder,Fish Oil
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oil capsuleDietary supplement
N-3 PUFAs is a kind of essential fatty acid,however the formation is too slow. Studies show that intakes of N-3 PUFAs is associated with MDD.It have to be got from food like deep-sea fishes. EPA and DHA are crucial for the body.Although studies have shown that reduced N-3 PUFAs were correlated with MDD, and patients with an elevated rate of N-6 PUFAs /N-3 PUFAs or a low level of DHA may be at higher odds for suicide. Trials on whether N-3 PUFAs is effective in the treatment of MDD is still controversial, which might be affected by several factors, such as dose, duration etc.. Now there is no large-scale randomized controlled clinical trial in determining the effects of N-3 PUFAs add-on in treatment of MDD.
soybean oil capsuleDietary supplement
placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | the experimental group will be given 4 fish oil capsules (1g/one capsule)twice daily after two meals at roughly the same time each day,lasting for the first 6 months.fish oil capsule will be provided by the Hunan Kangqi100 Biological Technology Co.Ltd. Receives: Dietary Supplement: fish oil capsule |
| control group | Placebo comparator | the control group will be given 4 soybean oil capsules ( placebo capsule,1g/one capsule) twice daily after two meals at roughly the same time each day,lasting for the first 6 months.placebo capsule will be provided by the Hunan Kangqi100 Biological Technology Co.Ltd.The placebo capsule's appearance and flavor are made the exactly the same as the fish oil capsules . Receives: Dietary Supplement: soybean oil capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Hamilton Depression Scale (HAMD) HAMD
Subjects were evaluated for current depression with HAMD.
Measured: W0 W4 W12 W24 W48
Secondary outcomes (4)
Changes in Clinical Global Impression (CGI)
Subjects were evaluated for current severity of disease with CGI.
Measured: W0 W4 W12 W24 W48
Changes in Hamilton Anxiety Scale (HAMA)
Subjects were evaluated for current anxiety with HAMA.
Measured: W0 W4 W12 W24 W48
Changes in Beck Depression Rating Scale (BDI)
The BDI is a self-report inventory of depression symptom.
Measured: W0 W4 W12 W24 W48
Changes in Self-Rating Anxiety Scale (SAS)
The SAS is a self-report inventory of anxiety symptom.
Measured: W0 W4 W12 W24 W48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 Oct 2017
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Jin-Dong Chen, Second Xiangya Hospital of Central South University
- Investigators
- Jindong Chen, MD, Study director, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295708
- Sponsor's protocol ID
- MDD201610
- Status last verified
- Oct 2017
- First submitted
- 18 Sep 2017
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: June 1,2020, Email to Dr. Chen Jindong(chenjd269@163.com)
Publications
Kessler RC, Birnbaum H, Bromet E, Hwang I, Sampson N, Shahly V. Age differences in major depression: results from the National Comorbidity Survey Replication (NCS-R). Psychol Med. 2010 Feb;40(2):225-37. doi: 10.1017/S0033291709990213. Epub 2009 Jun 17.
PubMed 19531277Monroe SM, Harkness KL. Recurrence in major depression: a conceptual analysis. Psychol Rev. 2011 Oct;118(4):655-74. doi: 10.1037/a0025190.
PubMed 21895384Appleton KM, Rogers PJ, Ness AR. Updated systematic review and meta-analysis of the effects of n-3 long-chain polyunsaturated fatty acids on depressed mood. Am J Clin Nutr. 2010 Mar;91(3):757-70. doi: 10.3945/ajcn.2009.28313. Epub 2010 Feb 3.
PubMed 20130098McNamara RK, Carlson SE. Role of omega-3 fatty acids in brain development and function: potential implications for the pathogenesis and prevention of psychopathology. Prostaglandins Leukot Essent Fatty Acids. 2006 Oct-Nov;75(4-5):329-49. doi: 10.1016/j.plefa.2006.07.010. Epub 2006 Sep 1.
PubMed 16949263Freeman MP, Rapaport MH. Omega-3 fatty acids and depression: from cellular mechanisms to clinical care. J Clin Psychiatry. 2011 Feb;72(2):258-9. doi: 10.4088/JCP.11ac06830. No abstract available.
PubMed 21382308Bloch MH, Hannestad J. Omega-3 fatty acids for the treatment of depression: systematic review and meta-analysis. Mol Psychiatry. 2012 Dec;17(12):1272-82. doi: 10.1038/mp.2011.100. Epub 2011 Sep 20.
PubMed 21931319Sprecher H. Metabolism of highly unsaturated n-3 and n-6 fatty acids. Biochim Biophys Acta. 2000 Jul 19;1486(2-3):219-31. doi: 10.1016/s1388-1981(00)00077-9. No abstract available.
PubMed 10903473Xie L, Innis SM. Association of fatty acid desaturase gene polymorphisms with blood lipid essential fatty acids and perinatal depression among Canadian women: a pilot study. J Nutrigenet Nutrigenomics. 2009;2(4-5):243-50. doi: 10.1159/000255636. Epub 2010 Apr 15.
PubMed 20395685Lalovic A, Klempan T, Sequeira A, Luheshi G, Turecki G. Altered expression of lipid metabolism and immune response genes in the frontal cortex of suicide completers. J Affect Disord. 2010 Jan;120(1-3):24-31. doi: 10.1016/j.jad.2009.04.007.
PubMed 19443042Wang F, Yuan H, Jin K, Tang H, Guo J, Wang CY, Chen J, Dong F, Wang L. Effects of fish oil supplementation on bone turnover markers in depression: a pilot study. Front Nutr. 2024 Dec 12;11:1464526. doi: 10.3389/fnut.2024.1464526. eCollection 2024.
PubMed 39726877Yang R, Wang L, Jin K, Cao S, Wu C, Guo J, Chen J, Tang H, Tang M. Omega-3 Polyunsaturated Fatty Acids Supplementation Alleviate Anxiety Rather Than Depressive Symptoms Among First-Diagnosed, Drug-Naive Major Depressive Disorder Patients: A Randomized Clinical Trial. Front Nutr. 2022 Jul 12;9:876152. doi: 10.3389/fnut.2022.876152. eCollection 2022.
PubMed 35903448Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
PubMed 34817851
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Effectiveness, and Mechanism of Fish Oil as Adjunct Treatment for Major Depressive Disorder - a 12-month Randomized, Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03295708
- Acronym / sponsor ID
- MDD201610
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder,Fish Oil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 28 Sep 2017 (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.
In this proposed study, the investigators will evaluate the effects of fish oil add-on in treatment of major depressive disorder(MDD).
Detailed description
Participants are randomly assigned to two groups (n=60): control (placebo, soybean) and fish oil (containing EPA 1440mg, DHA 960mg). The experimental groups will be compared to placebo to evaluate if it may benefit clinical symptoms, cognitive symptoms and metabolic markers in MDD patients. We also plan to investigate the changes in markers of inflammation at the same time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Dietary Supplement: fish oil capsulethe experimental group will be given 4 fish oil capsules (1g/one capsule)twice daily after two meals at roughly the same time each day,lasting for the first 6 months.fish oil capsule will be provided by the Hunan Kangqi100 Biological Technology Co.Ltd. |
| control group | Placebo comparator | Dietary Supplement: soybean oil capsulethe control group will be given 4 soybean oil capsules ( placebo capsule,1g/one capsule) twice daily after two meals at roughly the same time each day,lasting for the first 6 months.placebo capsule will be provided by the Hunan Kangqi100 Biological Technology Co.Ltd.The placebo capsule's appearance and flavor are made the exactly the same as the fish oil capsules . |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to provide informed consent
- Men or women aged 18-50 years
- A primary psychiatric diagnosis of major depressive disorder (MDD), by Diagnostic and Statistical Manual-5th ed (DSM-5) using the MINI
- HAMD total score≥21
- No significantly modification of their diet from the time they sign consent to the end of study participation
Key exclusion criteria (9 listed)
- Suffering from other serious somatic diseases or comorbidities
- Patients with serious nervous system disease
- Patients in accordance with diagnostic standards of other mental illness
- Patients who need to take benzodiazepine every day, and who currently need to be treated by electroconvulsive therapy or have received electroconvulsive therapy in the past 6 months
- Pregnant women or lactating women, women with pregnancy plans during the trial period (12 months), women with a high risk of pregnancy but without taking any contraceptive measures
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 |
|---|---|---|
| fish oil capsuleN-3 PUFAs is a kind of essential fatty acid,however the formation is too slow. Studies show that intakes of N-3 PUFAs is associated with MDD.It have to be got from food like deep-sea fishes. EPA and DHA are crucial for the body.Although studies have shown that reduced N-3 PUFAs were correlated with MDD, and patients with an elevated rate of N-6 PUFAs /N-3 PUFAs or a low level of DHA may be at higher odds for suicide. Trials on whether N-3 PUFAs is effective in the treatment of MDD is still controversial, which might be affected by several factors, such as dose, duration etc.. Now there is no large-scale randomized controlled clinical trial in determining the effects of N-3 PUFAs add-on in treatment of MDD. | Dietary supplement | experimental group |
| soybean oil capsuleplacebo capsule | Dietary supplement | control group |
Primary outcome
Changes in Hamilton Depression Scale (HAMD) HAMD
Time frame: W0 W4 W12 W24 W48
Subjects were evaluated for current depression with HAMD.
4 secondary outcomes
Changes in Clinical Global Impression (CGI)
Time frame: W0 W4 W12 W24 W48
Changes in Hamilton Anxiety Scale (HAMA)
Time frame: W0 W4 W12 W24 W48
Changes in Beck Depression Rating Scale (BDI)
Time frame: W0 W4 W12 W24 W48
Changes in Self-Rating Anxiety Scale (SAS)
Time frame: W0 W4 W12 W24 W48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Background: PubMed 19531277Kessler RC, Birnbaum H, Bromet E, Hwang I, Sampson N, Shahly V. Age differences in major depression: results from the National Comorbidity Survey Replication (NCS-R). Psychol Med. 2010 Feb;40(2):225-37. doi: 10.1017/S0033291709990213. Epub 2009 Jun 17.
- Background: PubMed 21895384Monroe SM, Harkness KL. Recurrence in major depression: a conceptual analysis. Psychol Rev. 2011 Oct;118(4):655-74. doi: 10.1037/a0025190.
- Background: PubMed 20130098Appleton KM, Rogers PJ, Ness AR. Updated systematic review and meta-analysis of the effects of n-3 long-chain polyunsaturated fatty acids on depressed mood. Am J Clin Nutr. 2010 Mar;91(3):757-70. doi: 10.3945/ajcn.2009.28313. Epub 2010 Feb 3.
- Background: PubMed 16949263McNamara RK, Carlson SE. Role of omega-3 fatty acids in brain development and function: potential implications for the pathogenesis and prevention of psychopathology. Prostaglandins Leukot Essent Fatty Acids. 2006 Oct-Nov;75(4-5):329-49. doi: 10.1016/j.plefa.2006.07.010. Epub 2006 Sep 1.
- Background: PubMed 21382308Freeman MP, Rapaport MH. Omega-3 fatty acids and depression: from cellular mechanisms to clinical care. J Clin Psychiatry. 2011 Feb;72(2):258-9. doi: 10.4088/JCP.11ac06830. No abstract available.
- Background: PubMed 21931319Bloch MH, Hannestad J. Omega-3 fatty acids for the treatment of depression: systematic review and meta-analysis. Mol Psychiatry. 2012 Dec;17(12):1272-82. doi: 10.1038/mp.2011.100. Epub 2011 Sep 20.
- Background: PubMed 10903473Sprecher H. Metabolism of highly unsaturated n-3 and n-6 fatty acids. Biochim Biophys Acta. 2000 Jul 19;1486(2-3):219-31. doi: 10.1016/s1388-1981(00)00077-9. No abstract available.
- Background: PubMed 20395685Xie L, Innis SM. Association of fatty acid desaturase gene polymorphisms with blood lipid essential fatty acids and perinatal depression among Canadian women: a pilot study. J Nutrigenet Nutrigenomics. 2009;2(4-5):243-50. doi: 10.1159/000255636. Epub 2010 Apr 15.
- Background: PubMed 19443042Lalovic A, Klempan T, Sequeira A, Luheshi G, Turecki G. Altered expression of lipid metabolism and immune response genes in the frontal cortex of suicide completers. J Affect Disord. 2010 Jan;120(1-3):24-31. doi: 10.1016/j.jad.2009.04.007.
- Derived from this study: PubMed 39726877Wang F, Yuan H, Jin K, Tang H, Guo J, Wang CY, Chen J, Dong F, Wang L. Effects of fish oil supplementation on bone turnover markers in depression: a pilot study. Front Nutr. 2024 Dec 12;11:1464526. doi: 10.3389/fnut.2024.1464526. eCollection 2024.
- Derived from this study: PubMed 35903448Yang R, Wang L, Jin K, Cao S, Wu C, Guo J, Chen J, Tang H, Tang M. Omega-3 Polyunsaturated Fatty Acids Supplementation Alleviate Anxiety Rather Than Depressive Symptoms Among First-Diagnosed, Drug-Naive Major Depressive Disorder Patients: A Randomized Clinical Trial. Front Nutr. 2022 Jul 12;9:876152. doi: 10.3389/fnut.2022.876152. eCollection 2022.
- Derived from this study: PubMed 34817851Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.
- Individual participant dataSharing planned: Undecided. June 1,2020, Email to Dr. Chen Jindong(chenjd269@163.com)
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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.
Jindong Chen, MD study director
Second Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fish oil capsule and soybean oil capsule in people with Major Depressive Disorder, run by Second Xiangya Hospital of Central South University 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 5 inclusion and 9 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 10 Oct 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Lu Wang, MD (+8615116331768, luwang112@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Hamilton Depression Scale (HAMD) HAMD (time frame: W0 W4 W12 W24 W48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03295708, which also lists 12 linked publications.
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 10 Oct 2017.