NCT03295708

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

September 18, 2017

Last Update Submit

October 6, 2017

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder,Fish Oil

Outcome Measures

Primary Outcomes (1)

  • Changes in Hamilton Depression Scale (HAMD) HAMD

    Subjects were evaluated for current depression with HAMD.

    W0 W4 W12 W24 W48

Secondary Outcomes (4)

  • Changes in Clinical Global Impression (CGI)

    W0 W4 W12 W24 W48

  • Changes in Hamilton Anxiety Scale (HAMA)

    W0 W4 W12 W24 W48

  • Changes in Beck Depression Rating Scale (BDI)

    W0 W4 W12 W24 W48

  • Changes in Self-Rating Anxiety Scale (SAS)

    W0 W4 W12 W24 W48

Study Arms (2)

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.

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 .

Dietary Supplement: soybean oil capsule

Interventions

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.

experimental group
soybean oil capsuleDIETARY_SUPPLEMENT

placebo capsule

control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Institute, Second Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

Related Publications (12)

  • 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.

    PMID: 19531277BACKGROUND

  • Monroe SM, Harkness KL. Recurrence in major depression: a conceptual analysis. Psychol Rev. 2011 Oct;118(4):655-74. doi: 10.1037/a0025190.

    PMID: 21895384BACKGROUND

  • 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.

    PMID: 20130098BACKGROUND

  • 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.

    PMID: 16949263BACKGROUND

  • 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.

    PMID: 21382308BACKGROUND

  • 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.

    PMID: 21931319BACKGROUND

  • 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.

    PMID: 10903473BACKGROUND

  • 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.

    PMID: 20395685BACKGROUND

  • 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.

    PMID: 19443042BACKGROUND

  • 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.

    PMID: 39726877DERIVED

  • 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.

    PMID: 35903448DERIVED

  • 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.

    PMID: 34817851DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Fish OilsSoybean Oil

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

OilsLipidsDietary Fats, UnsaturatedDietary FatsFatsFats, UnsaturatedPlant OilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jindong Chen, MD

    Second Xiangya Hospital of Central South University

    STUDY DIRECTOR

Central Study Contacts

Lu Wang, MD

CONTACT

+8615116331768luwang112@163.com

Mimi Tang, MD

CONTACT

+8615802607545tangmimi1989@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Mental Health Institute of the Second Xiangya Hospital

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 28, 2017

Study Start

October 1, 2017

Primary Completion

October 1, 2019

Study Completion

April 1, 2020

Last Updated

October 10, 2017

Record last verified: 2017-10

Locations

CN(1)