Fish Oil as Adjunct Treatment for Major Depressive Disorder

Overview

In this proposed study, the investigators will evaluate the effects of fish oil add-on in treatment of major depressive disorder(MDD).

Full Title of Study: “Safety, Effectiveness, and Mechanism of Fish Oil as Adjunct Treatment for Major Depressive Disorder – a 12-month Randomized, Placebo Controlled Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 1, 2019

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.

Interventions

  • Dietary Supplement: 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.
  • Dietary Supplement: soybean oil capsule
    • placebo capsule

Arms, Groups and Cohorts

  • Experimental: 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.
  • Placebo Comparator: 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 .

Clinical Trial Outcome Measures

Primary Measures

  • Changes in Hamilton Depression Scale (HAMD) HAMD
    • Time Frame: W0 W4 W12 W24 W48
    • Subjects were evaluated for current depression with HAMD.

Secondary Measures

  • Changes in Clinical Global Impression (CGI)
    • Time Frame: W0 W4 W12 W24 W48
    • Subjects were evaluated for current severity of disease with CGI.
  • Changes in Hamilton Anxiety Scale (HAMA)
    • Time Frame: W0 W4 W12 W24 W48
    • Subjects were evaluated for current anxiety with HAMA.
  • Changes in Beck Depression Rating Scale (BDI)
    • Time Frame: W0 W4 W12 W24 W48
    • The BDI is a self-report inventory of depression symptom.
  • Changes in Self-Rating Anxiety Scale (SAS)
    • Time Frame: W0 W4 W12 W24 W48
    • The SAS is a self-report inventory of anxiety symptom.

Participating in This Clinical Trial

Inclusion Criteria

1. Able to provide informed consent

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

1. Suffering from other serious somatic diseases or comorbidities

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Second Xiangya Hospital of Central South University
  • Collaborator
    • Xiangya Hospital of Central South University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin-Dong Chen, Director of Mental Health Institute of the Second Xiangya Hospital – Second Xiangya Hospital of Central South University
  • Overall Official(s)
    • Jindong Chen, MD, Study Director, Central South University
  • Overall Contact(s)
    • Lu Wang, MD, +8615116331768, luwang112@163.com

References

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. Erratum in: Psychol Rev. 2011 Oct;118(4):674.

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. Review.

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. Epub 2006 Sep 1. Review.

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. Review.

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. Review.

Sprecher H. Metabolism of highly unsaturated n-3 and n-6 fatty acids. Biochim Biophys Acta. 2000 Jul 19;1486(2-3):219-31. Review.

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.

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