- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03295708
Fish Oil as Adjunct Treatment for Major Depressive Disorder
October 6, 2017 updated by: Jin-Dong Chen, Second Xiangya Hospital of Central South University
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lu Wang, MD
- Phone Number: +8615116331768
- Email: luwang112@163.com
Study Contact Backup
- Name: Mimi Tang, MD
- Phone Number: +8615802607545
- Email: tangmimi1989@163.com
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410000
- Recruiting
- Mental Health Institute, Second Xiangya Hospital of Central South University
-
Contact:
- Lu Wang, M.D.
- Phone Number: +8615116331768
- Email: luwang112@163.com
-
Contact:
- Mi Mi Tang, M.D.
- Phone Number: +8617136372000
- Email: tangmimi1989@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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 .
|
placebo capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Hamilton Depression Scale (HAMD) HAMD
Time Frame: W0 W4 W12 W24 W48
|
Subjects were evaluated for current depression with HAMD.
|
W0 W4 W12 W24 W48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Clinical Global Impression (CGI)
Time Frame: W0 W4 W12 W24 W48
|
Subjects were evaluated for current severity of disease with CGI.
|
W0 W4 W12 W24 W48
|
Changes in Hamilton Anxiety Scale (HAMA)
Time Frame: W0 W4 W12 W24 W48
|
Subjects were evaluated for current anxiety with HAMA.
|
W0 W4 W12 W24 W48
|
Changes in Beck Depression Rating Scale (BDI)
Time Frame: W0 W4 W12 W24 W48
|
The BDI is a self-report inventory of depression symptom.
|
W0 W4 W12 W24 W48
|
Changes in Self-Rating Anxiety Scale (SAS)
Time Frame: W0 W4 W12 W24 W48
|
The SAS is a self-report inventory of anxiety symptom.
|
W0 W4 W12 W24 W48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Jindong Chen, MD, Central South University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Anticipated)
October 1, 2019
Study Completion (Anticipated)
April 1, 2020
Study Registration Dates
First Submitted
September 18, 2017
First Submitted That Met QC Criteria
September 22, 2017
First Posted (Actual)
September 28, 2017
Study Record Updates
Last Update Posted (Actual)
October 10, 2017
Last Update Submitted That Met QC Criteria
October 6, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDD201610
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
June 1,2020, Email to Dr. Chen Jindong(chenjd269@163.com)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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