Fish Oil as Adjunct Treatment for Major Depressive Disorder
NCT ID: NCT03295708
Last Updated: 2017-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2017-10-01
2020-04-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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experimental group
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.
fish oil capsule
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.
control group
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 .
soybean oil capsule
placebo capsule
Interventions
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fish oil capsule
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 capsule
placebo capsule
Eligibility Criteria
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Inclusion Criteria
2. Men or women aged 18-50 years
3. A primary psychiatric diagnosis of major depressive disorder (MDD), by Diagnostic and Statistical Manual-5th ed (DSM-5) using the MINI
4. HAMD total scoreā„21
5. No significantly modification of their diet from the time they sign consent to the end of study participation
Exclusion Criteria
2. Patients with serious nervous system disease
3. Patients in accordance with diagnostic standards of other mental illness
4. 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
5. 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
6. Patients with apparent suicide attempt or suicidal behavior
7. 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
8. Allergy history of PUFA
9. Intake of Fish oil more than 3g per day or eat fatty fish more than 3 times a week
18 Years
50 Years
ALL
No
Sponsors
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Xiangya Hospital of Central South University
OTHER
Second Xiangya Hospital of Central South University
OTHER
Responsible Party
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Jin-Dong Chen
Director of Mental Health Institute of the Second Xiangya Hospital
Principal Investigators
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Jindong Chen, MD
Role: STUDY_DIRECTOR
Second Xiangya Hospital of Central South University
Locations
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Mental Health Institute, Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Lu Wang, M.D.
Role: primary
Mi Mi Tang, M.D.
Role: backup
References
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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.
Monroe SM, Harkness KL. Recurrence in major depression: a conceptual analysis. Psychol Rev. 2011 Oct;118(4):655-74. doi: 10.1037/a0025190.
Appleton 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.
McNamara 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.
Freeman 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.
Bloch 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.
Sprecher 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.
Xie 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.
Lalovic 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.
Wang 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.
Yang 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.
Appleton 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MDD201610
Identifier Type: -
Identifier Source: org_study_id