Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis
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| ClinicalTrials.gov Identifier: NCT00122954 |
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Recruitment Status :
Completed
First Posted : July 22, 2005
Results First Posted : January 14, 2014
Last Update Posted : June 8, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Sclerosis Depression | Drug: Fish oil concentrate Drug: Placebo | Phase 1 Phase 2 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 39 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis |
| Study Start Date : | July 2005 |
| Actual Primary Completion Date : | June 2009 |
| Actual Study Completion Date : | June 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Fish oil concentrate
Fish oil concentrate
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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 |
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Placebo Comparator: Placebo oil
Placebo oil
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Drug: Placebo
soybean oil with 1% fish oil at a daily dose of 6 grams |
- 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).
- 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.
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122954
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | Lynne Shinto, ND, MPH | Oregon Health and Science University |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Lynne Shinto, Lynn Shinto, ND, MPH, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT00122954 History of Changes |
| Other Study ID Numbers: |
K23AT002155-01 ( U.S. NIH Grant/Contract ) K23AT002155-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 22, 2005 Key Record Dates |
| Results First Posted: | January 14, 2014 |
| Last Update Posted: | June 8, 2017 |
| Last Verified: | May 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Lynne Shinto, Oregon Health and Science University:
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Fatty Acids, Omega-3 Fish Oils Complementary Therapies |
Additional relevant MeSH terms:
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Depression Depressive Disorder Sclerosis Multiple Sclerosis Behavioral Symptoms Mood Disorders Mental Disorders |
Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |