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

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00122954
First received: July 20, 2005
Last updated: May 11, 2017
Last verified: May 2017
Results First Received: November 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Conditions: Multiple Sclerosis
Depression
Interventions: Drug: Fish oil concentrate
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo 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.
Omega-3 Fatty Acids 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).

Participant Flow:   Overall Study
    Placebo   Omega-3 Fatty Acids
STARTED   18   21 
COMPLETED   16   18 
NOT COMPLETED   2   3 
Withdrawal by Subject                2                2 
Protocol Violation                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants receiving soybean placebo with 1% fish oil at a daily dose of 6 grams.
Fish Oil Concentrate Participants receiving fish oil concentrate at a daily dose of 6 grams (2.1 grams EPA and 1.5 grams DHA)
Total Total of all reporting groups

Baseline Measures
   Placebo   Fish Oil Concentrate   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   21   39 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.9  (10.0)   50.7  (11.6)   51.3  (1.81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      17  94.4%      19  90.5%      36  92.3% 
Male      1   5.6%      2   9.5%      3   7.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 17.2  (10.0)   16.6  (9.5)   17  (10.42) 
Expanded Disability Status Scale (EDSS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.1  (2.4)   3.2  (2.1)   3.6  (2.3) 
[1] 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] 
[Units: Participants]
Mean (Standard Deviation)
 19.1  (4.0)   18.4  (5.3)   18.75  (4.82) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 19.6  (5.7)   20.1  (8.0)   19.97  (7.05) 
[1] 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 
[Units: % total fatty acids]
Mean (Standard Deviation)
 0.61  (0.3)   0.58  (0.2)   0.59  (0.24) 
Docosahexaenoic Acid 
[Units: % total fatty acids]
Mean (Standard Deviation)
 3.9  (1.2)   4.0  (1.0)   4.0  (1.0) 
Adequate antidepressant use [1] 
[Units: Participants]
Count of Participants
 12   16   28 
[1] 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] 
[Units: Participants]
Count of Participants
 12   13   25 
[1] MS DMT use includes: glatiramer acetate, interferon beta-1a, interferon beta-1b


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Montgomery-Asberg Depression Rating Scale (MADRS)   [ Time Frame: baseline to 3 months ]

2.  Secondary:   Quality of Life (SF-36)   [ Time Frame: baseline to 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Lynne Shinto, ND, MPH
Organization: Oregon Health & Science University
phone: 503-494-5035
e-mail: shintol@ohsu.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00122954     History of Changes
Other Study ID Numbers: K23AT002155-01 ( U.S. NIH Grant/Contract )
Study First Received: July 20, 2005
Results First Received: November 25, 2013
Last Updated: May 11, 2017