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| Sponsor: | Oregon Health and Science University |
|---|---|
| Collaborator: |
National Center for Complementary and Alternative Medicine (NCCAM) |
| Information provided by: | Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT00122954 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis Depression |
Drug: Fish oil capsules |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis |
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lauren E Stuber, BS | 503-494-3549 | stuberl@ohsu.edu |
| United States, Oregon | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Rachel R. Frank, BA 503-494-7963 frankra@ohsu.edu | |
| Contact: Lynne Shinto, ND 503-494-5035 shintol@ohsu.edu | |
| Principal Investigator: Lynne Shinto, ND | |
| Sub-Investigator: Dennis Bourdette, MD | |
| Principal Investigator: | Lynne Shinto, ND | Oregon Health and Science University |
More Information
| Responsible Party: | Lynn H. Shinto, Principal Investigator, 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 |
| Last Updated: | November 19, 2009 |
| Health Authority: | United States: Federal Government |
|
Fatty Acids, Omega-3 Fish Oils Complementary Therapies |
|
Depression Depressive Disorder Multiple Sclerosis Sclerosis Behavioral Symptoms Mood Disorders Mental Disorders |
Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |