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

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ClinicalTrials.gov Identifier: NCT00122954
Recruitment Status : Completed
First Posted : July 22, 2005
Results First Posted : January 14, 2014
Last Update Posted : June 8, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Multiple Sclerosis
Depression
Interventions Drug: Fish oil concentrate
Drug: Placebo
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Omega-3 Fatty Acids
Hide Arm/Group Description Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules. Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
Period Title: Overall Study
Started 18 21
Completed 16 18
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             2             2
Protocol Violation             0             1
Arm/Group Title Placebo Fish Oil Concentrate Total
Hide Arm/Group Description Participants receiving soybean placebo with 1% fish oil at a daily dose of 6 grams. Participants receiving fish oil concentrate at a daily dose of 6 grams (2.1 grams EPA and 1.5 grams DHA) Total of all reporting groups
Overall Number of Baseline Participants 18 21 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 21 participants 39 participants
51.9  (10.0) 50.7  (11.6) 51.3  (1.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 21 participants 39 participants
Female
17
  94.4%
19
  90.5%
36
  92.3%
Male
1
   5.6%
2
   9.5%
3
   7.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 21 participants 39 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
18
 100.0%
21
 100.0%
39
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Disease duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 21 participants 39 participants
17.2  (10.0) 16.6  (9.5) 17  (10.42)
Expanded Disability Status Scale (EDSS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 21 participants 39 participants
4.1  (2.4) 3.2  (2.1) 3.6  (2.3)
[1]
Measure Description: The EDSS is an ordinal scale giving a measure of neurological impairment on a scale between 0 (normal) to 10 (dead). Patient with scores in the 0.5-4.0 range have mild disability and are able to walk at least 500 meters without aid or rest. Patients with scores > 7 cannot walk and have upper extremity dysfunction.
Montgomery-Asberg Depression Rating Scale (MADRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Participants
Number Analyzed 18 participants 21 participants 39 participants
19.1  (4.0) 18.4  (5.3) 18.75  (4.82)
[1]
Measure Description: The MADRS is a structured interview assessment of depression, designed to be especially sensitive to changes in patients' depression symptoms after antidepressant therapy. The MADRS scale is more oriented towards psychic rather than somatic symptoms of depression. Scores between 11-30 indicate mild to moderate depression.
Beck Depression Inventory (BDI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 21 participants 39 participants
19.6  (5.7) 20.1  (8.0) 19.97  (7.05)
[1]
Measure Description: The BDI is a 21-item self-report measure of depression, and is commonly used in MS studies. It is an easily administered measure for depression that is not clinician-depression. Scores range from 0-63 with a higher score indicating greater depression. A score > 19 indicates moderate to severe depression.
Eicosapentaenoic Acid  
Mean (Standard Deviation)
Unit of measure:  % total fatty acids
Number Analyzed 18 participants 21 participants 39 participants
0.61  (0.3) 0.58  (0.2) 0.59  (0.24)
Docosahexaenoic Acid  
Mean (Standard Deviation)
Unit of measure:  % total fatty acids
Number Analyzed 18 participants 21 participants 39 participants
3.9  (1.2) 4.0  (1.0) 4.0  (1.0)
Adequate antidepressant use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 21 participants 39 participants
12
  66.7%
16
  76.2%
28
  71.8%
[1]
Measure Description: Per protocol, all participants were on one antidepressant medication. Adequate antidepressant dose is defined as minimal clinical dose to two times minimal clinical dose.
Multiple sclerosis modifying therapy (MS DMT) use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 21 participants 39 participants
12
  66.7%
13
  61.9%
25
  64.1%
[1]
Measure Description: MS DMT use includes: glatiramer acetate, interferon beta-1a, interferon beta-1b
1.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description 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).
Time Frame baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 8 participants discontinued intervention (placebo n = 2, 1 colitis and 1 swallowing problems; treatment n = 6, 2 lost to follow-up, 1 bronchitis, 1 knee surgery, 1 went off antidepressant, 1 travel issues) and did not complete outcome measures
Arm/Group Title Placebo Omega-3 Fatty Acids
Hide Arm/Group Description:
Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
Overall Number of Participants Analyzed 16 15
Measure Type: Number
Unit of Measure: percentage of subjects
45.5 47.4
2.Secondary Outcome
Title Quality of Life (SF-36)
Hide Description 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.
Time Frame baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 8 participants discontinued (placebo n = 2, 1 colitis, 1 swallowing problems; treatment n = 8, 2 lost to follow-up, 1 bronchitis, 1 knee surgery, 1 went off anti-depressant, 1 travel difficulties) and did not complete measures at end of study
Arm/Group Title Placebo Omega-3 Fatty Acids
Hide Arm/Group Description:
Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
Overall Number of Participants Analyzed 16 15
Mean (Standard Error)
Unit of Measure: mean change of units on a scale
Physical (PCS) -0.8  (0.8) 1.6  (0.8)
Mental (MCS) 4.2  (1.0) 1.5  (1.0)
Time Frame Adverse event data were collected from baseline to end of study at 3 months
Adverse Event Reporting Description Participants were monitored twice a month (either in clinic or by phone) for general health events, worsening of depression (>30 Beck's Depression Inventory), and suicidal ideation. Worsening of depression or MS-related symptoms would result in referrals for care and withdrawal from the study. General adverse events were assessed by type, severity, relationship to supplement, action taken, and outcome.
 
Arm/Group Title Placebo Omega-3 Fatty Acids
Hide Arm/Group Description Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules. Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
All-Cause Mortality
Placebo Omega-3 Fatty Acids
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Omega-3 Fatty Acids
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/21 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Omega-3 Fatty Acids
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/18 (88.89%)      11/21 (52.38%)    
Cardiac disorders     
arrhythmia  1  0/18 (0.00%)  0 1/21 (4.76%)  1
Gastrointestinal disorders     
diarrhea  1  1/18 (5.56%)  1 1/21 (4.76%)  1
nausea  1  0/18 (0.00%)  0 1/21 (4.76%)  1
colitis  1  1/18 (5.56%)  1 0/21 (0.00%)  0
Immune system disorders     
multiple sclerosis relapse  1 [1]  3/18 (16.67%)  3 0/21 (0.00%)  0
fatigue  1 [2]  3/18 (16.67%)  3 0/21 (0.00%)  0
Infections and infestations     
cold or flu  1  3/18 (16.67%)  3 3/21 (14.29%)  3
Nervous system disorders     
numbness and tingling  1 [3]  2/18 (11.11%)  2 0/21 (0.00%)  0
dizziness  1  1/18 (5.56%)  1 1/21 (4.76%)  1
Renal and urinary disorders     
Urinary Tract Infection  1  4/18 (22.22%)  4 0/21 (0.00%)  0
Reproductive system and breast disorders     
prolonged menstruation  1  0/18 (0.00%)  0 1/21 (4.76%)  1
Skin and subcutaneous tissue disorders     
bruising  1  0/18 (0.00%)  0 3/21 (14.29%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[1]
subject report of multiple sclerosis relapse
[2]
subject reported as MS-related fatigue
[3]
MS related
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lynne Shinto, ND, MPH
Organization: Oregon Health & Science University
Phone: 503-494-5035
EMail: shintol@ohsu.edu
Layout table for additonal information
Responsible Party: Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00122954    
Other Study ID Numbers: K23AT002155-01 ( U.S. NIH Grant/Contract )
K23AT002155-01 ( U.S. NIH Grant/Contract )
First Submitted: July 20, 2005
First Posted: July 22, 2005
Results First Submitted: November 25, 2013
Results First Posted: January 14, 2014
Last Update Posted: June 8, 2017