Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23AT002155-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish oil concentrate | Experimental | Fish oil concentrate |
|
| Placebo oil | Placebo Comparator | Placebo oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish oil concentrate | Drug | fish oil concentrate at a daily dose of 6 grams (2.1 gram EPA and 1.5 gram DHA). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | 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). | baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (SF-36) | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lynne Shinto, ND, MPH | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11870016 | Background | Nemets B, Stahl Z, Belmaker RH. Addition of omega-3 fatty acid to maintenance medication treatment for recurrent unipolar depressive disorder. Am J Psychiatry. 2002 Mar;159(3):477-9. doi: 10.1176/appi.ajp.159.3.477. | |
| 12888186 | Background | Su KP, Huang SY, Chiu CC, Shen WW. Omega-3 fatty acids in major depressive disorder. A preliminary double-blind, placebo-controlled trial. Eur Neuropsychopharmacol. 2003 Aug;13(4):267-71. doi: 10.1016/s0924-977x(03)00032-4. |
| Label | URL |
|---|---|
| Click here for more information about complementary and alternative medicine-related research at Oregon Health and Science University | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants receiving soybean placebo with 1% fish oil at a daily dose of 6 grams. |
| BG001 | Fish Oil Concentrate | Participants receiving fish oil concentrate at a daily dose of 6 grams (2.1 grams EPA and 1.5 grams DHA) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Montgomery-Asberg Depression Rating Scale (MADRS) | 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). | 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 | Posted | Number | percentage of subjects | baseline to 3 months |
|
Adverse event data were collected from baseline to end of study at 3 months
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynne Shinto, ND, MPH | Oregon Health & Science University | 503-494-5035 | shintol@ohsu.edu |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | soybean oil with 1% fish oil at a daily dose of 6 grams |
|
| baseline to 3 months |
| 12365878 | Background | Peet M, Horrobin DF. A dose-ranging study of the effects of ethyl-eicosapentaenoate in patients with ongoing depression despite apparently adequate treatment with standard drugs. Arch Gen Psychiatry. 2002 Oct;59(10):913-9. doi: 10.1001/archpsyc.59.10.913. |
| 26799942 | Derived | Shinto L, Marracci G, Mohr DC, Bumgarner L, Murchison C, Senders A, Bourdette D. Omega-3 Fatty Acids for Depression in Multiple Sclerosis: A Randomized Pilot Study. PLoS One. 2016 Jan 22;11(1):e0147195. doi: 10.1371/journal.pone.0147195. eCollection 2016. |
| Click here for more information about research studies at the Multiple Sclerosis Center of Oregon | View source |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Disease duration | Mean | Standard Deviation | years |
|
| Expanded Disability Status Scale (EDSS) | 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. | Mean | Standard Deviation | units on a scale |
|
| Montgomery-Asberg Depression Rating Scale (MADRS) | 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. | Mean | Standard Deviation | participants |
|
| Beck Depression Inventory (BDI) | 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. | Mean | Standard Deviation | units on a scale |
|
| Eicosapentaenoic Acid | Mean | Standard Deviation | % total fatty acids |
|
| Docosahexaenoic Acid | Mean | Standard Deviation | % total fatty acids |
|
| Adequate antidepressant use | Per protocol, all participants were on one antidepressant medication. Adequate antidepressant dose is defined as minimal clinical dose to two times minimal clinical dose. | Count of Participants | Participants |
|
| Multiple sclerosis modifying therapy (MS DMT) use | MS DMT use includes: glatiramer acetate, interferon beta-1a, interferon beta-1b | Count of Participants | Participants |
|
| OG001 | 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). |
|
|
| Secondary | Quality of Life (SF-36) | 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. | 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 | Posted | Mean | Standard Error | mean change of units on a scale | baseline to 3 months |
|
|
|
| 0 |
| 18 |
| 16 |
| 18 |
| EG001 | 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). | 0 | 21 | 11 | 21 |
| multiple sclerosis relapse | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment | subject report of multiple sclerosis relapse |
|
| cold or flu | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| bruising | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| fatigue | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment | subject reported as MS-related fatigue |
|
| numbness and tingling | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | MS related |
|
| colitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| arrhythmia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| prolonged menstruation | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |