Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis

Tracking Information
First Submitted Date ICMJE	July 20, 2005
First Posted Date ICMJE	July 22, 2005
Results First Submitted Date	November 25, 2013
Results First Posted Date	January 14, 2014
Last Update Posted Date	June 8, 2017
Study Start Date ICMJE	July 2005
Actual Primary Completion Date	June 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 11, 2017)	Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline to 3 months ]; Higher MADRS scores indicate more severe depression, and the overall score ranges from 0-60. A score of 0-6 indicates symptoms absent, 7-19 indicates mild depression, 20-34 moderate, and > 34 severe. Our primary outcome was 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS).
Original Primary Outcome Measures ICMJE; (submitted: July 21, 2005)	Three month change in MADRS scores; three month change in interferon-gamma (IFN-g) levels
Change History	Complete list of historical versions of study NCT00122954 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 11, 2017)	Quality of Life (SF-36) [ Time Frame: baseline to 3 months ]; SF-36 is a commonly used measure of health-related quality of life and is well validated in many disease conditions. Responses are self-administered and responses are summed into two subscores, the mental component summary (MCS) and physical component summary (PCS). The SF-36 has eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed on a 0-100 scale. Higher scores represent higher function.
Original Secondary Outcome Measures ICMJE; (submitted: July 21, 2005)	Whether the change in IFN-g level is correlated with the change in MADRS scores
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis
Official Title ICMJE	Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis
Brief Summary	This study will determine whether fish oil can reduce depression in people with multiple sclerosis (MS) who are mild to moderately depressed and are currently taking antidepressant medication. Study hypothesis: Three months of fish oil supplementation will improve depression scores on the Montgomery-Asberg depression rating scale (MADRS) or Beck Depression Inventory (BDI) better than placebo.
Detailed Description	Depression occurs in 50% to 60% of all individuals with MS. Evidence suggests that the omega-3 fatty acids in fish oil supplements can significantly reduce depression with a low risk of side effects. Therefore, fish oil supplements may be a safe adjunctive therapy to improve the therapeutic benefits of antidepressants. This study will determine the effectiveness of fish oil supplements in reducing depression in MS patients who are taking antidepressant medication. This study will last 3 months. Participants will be randomly assigned to receive either fish oil supplements or placebo daily for 3 months. At the end of 3 months, participants who show an improvement in their depressive symptoms will have the option to continue their treatment for an additional 3 months. Participants will do no respond to treatment will be excused from the study. All participants will remain on their antidepressants and MS medication throughout the study. Participants will have weekly study visits. At each visit, participants will be asked about their general health, and self-report scales will be used to assess depressive symptoms. Medication adherence will be monitored by pill counts and through red blood cell fatty acid analysis. Blood collection will occur at study start and at study completion.
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Multiple Sclerosis; Depression
Intervention ICMJE	Drug: Fish oil concentrate fish oil concentrate at a daily dose of 6 grams (2.1 gram EPA and 1.5 gram DHA). Other Name: omega-3 fatty acids; Drug: Placebo soybean oil with 1% fish oil at a daily dose of 6 grams
Study Arms	Experimental: Fish oil concentrate Fish oil concentrate Intervention: Drug: Fish oil concentrate; Placebo Comparator: Placebo oil Placebo oil Intervention: Drug: Placebo
Publications *	Nemets B, Stahl Z, Belmaker RH. Addition of omega-3 fatty acid to maintenance medication treatment for recurrent unipolar depressive disorder. Am J Psychiatry. 2002 Mar;159(3):477-9.; Su KP, Huang SY, Chiu CC, Shen WW. Omega-3 fatty acids in major depressive disorder. A preliminary double-blind, placebo-controlled trial. Eur Neuropsychopharmacol. 2003 Aug;13(4):267-71. Erratum in: Eur Neuropsychopharmacol. 2004 Mar;14(2):173.; Peet M, Horrobin DF. A dose-ranging study of the effects of ethyl-eicosapentaenoate in patients with ongoing depression despite apparently adequate treatment with standard drugs. Arch Gen Psychiatry. 2002 Oct;59(10):913-9.; Shinto L, Marracci G, Mohr DC, Bumgarner L, Murchison C, Senders A, Bourdette D. Omega-3 Fatty Acids for Depression in Multiple Sclerosis: A Randomized Pilot Study. PLoS One. 2016 Jan 22;11(1):e0147195. doi: 10.1371/journal.pone.0147195. eCollection 2016.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 7, 2014)	39
Original Enrollment ICMJE; (submitted: July 21, 2005)	60
Actual Study Completion Date	June 2009
Actual Primary Completion Date	June 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Diagnosis of relapsing-remitting MS; Diagnosis of depressive disorder; Score between 11 and 30 on the Montgomery-Asberg Depression Rating Scale (MADRS); Score of 25 or greater on the Mini-Mental State Examination (MMSE); Currently taking antidepressant medication for at least 3 months prior to study entry Exclusion Criteria: Currently taking fatty acid supplements; Consume more than 6 oz of fish per week within 1 month prior to study entry; Severe depression; Suicidal thoughts; Other psychological disorders; Currently taking more than two types of antidepressants; Any serious medical condition that would interfere with the study; Worsening of MS symptoms or corticosteroid treatment within 1 month prior to study entry; Current enrollment in another fish oil study; Pregnancy
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 85 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00122954
Other Study ID Numbers ICMJE	K23AT002155-01( U.S. NIH Grant/Contract ); K23AT002155-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Undecided
Responsible Party	Lynne Shinto, Oregon Health and Science University
Study Sponsor ICMJE	Oregon Health and Science University
Collaborators ICMJE	National Center for Complementary and Integrative Health (NCCIH)
Investigators ICMJE	Principal Investigator: Lynne Shinto, ND, MPH Oregon Health and Science University
PRS Account	Oregon Health and Science University
Verification Date	May 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP