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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00122954
First received: July 20, 2005
Last updated: November 25, 2013
Last verified: November 2013
Results First Received: November 25, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Conditions: Multiple Sclerosis
Depression
Intervention: Drug: Fish oil capsules

  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.
The study was powered to enroll twenty six subjects (13/group), the number needed to see a difference in Hamilton Depression Rating Scale (HDRS) over 3 months. The Montgomery Asberg Rating Scale has good validation with the HDRS and is more sensitive to emotional change than the HDRS.

Reporting Groups
  Description
Placebo Versus Omega-3 Fatty Acids No text entered.

Baseline Measures
    Placebo Versus Omega-3 Fatty Acids  
Number of Participants  
[units: participants]
  39  
Age  
[units: years]
Mean ± Standard Deviation
 
Placebo     51.8  ± 10.2  
Omega-3 Fatty Acid     50.6  ± 11.5  
Gender  
[units: participants]
 
Female     36  
Male     3  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     39  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment [1]
[units: participants]
 
United States     39  
[1] Portland metropolitan area



  Outcome Measures

1.  Primary:   Fifty Percent Improvement in Montgomery Asberg Depression Rating Scale After 3 Months of Treatment Was Used as the Primary Outcome Measure as This Would be Considered a Clinically Significant Change in Depression   [ Time Frame: 3 months ]

2.  Secondary:   Quality of Life (SF-36)   [ Time Frame: 3 months ]
Results not yet posted.   Anticipated Posting Date:   12/2013   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


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:

Responsible Party: Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00122954     History of Changes
Other Study ID Numbers: K23 AT002155-01, K23AT002155-01
Study First Received: July 20, 2005
Results First Received: November 25, 2013
Last Updated: November 25, 2013
Health Authority: United States: Federal Government