Abstract
Multiple sclerosis is the most common chronic disabling disease in the central nervous system in young to middle aged adults. Depression is common in multiple sclerosis (MS) affecting between 50–60% of patients. Pilot studies in unipolar depression report an improvement in depression when omega-3 fatty acids are given with antidepressants. The objective of this study was to investigate whether omega-3 fatty acid supplementation, as an augmentation therapy, improves treatment-resistant major depressive disorder (MDD) in people with MS. We performed a randomized, double-blind, placebo-controlled pilot study of omega-3 fatty acids at six grams per day over three months. The primary outcome was a 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS). Thirty-nine participants were randomized and thirty-one completed the 3-month intervention. Improvement on MADRS between groups was not significantly different at the 3-month end point with 47.4% in the omega-3 fatty acid group and 45.5% in the placebo group showing 50% or greater improvement (p = 0.30). Omega-3 fatty acids as an augmentation therapy for treatment-resistant depression in MS was not significantly different than placebo in this pilot trial. Omega-3 fatty acid supplementation at the dose given was well-tolerated over 3 months.Trial RegistrationClinicalTrials.gov NCT00122954
Highlights
Multiple sclerosis (MS) is the most common chronic disabling disease of the central nervous system affecting young and middle aged adults with a typical onset age between 20 and 55 years
EDSS: Expanded Disability Status Scale; MADRS: Montgomery-Asberg Depression Rating Scale; BDI: Beck Depression Inventory; eicosapentaenoic acid (EPA): Eicosapentaenoic Acid measured from red blood cell membranes; docosahexaenoic acid (DHA): Docosahexaenoic Acid measured from red blood cell membranes; MS DMT Use: MS Disease Modifying Therapy use includes: glatiramer acetate, interferon beta-1a, interferon beta-1b. aPer protocol all participants were on one antidepressant medication
Per protocol all participants were on antidepressant medication, 66.7% of the placebo group and 88.9% of the omega-3 FA group were adequately dosed [21] with no significant difference between groups being adequately dosed (p = 0.23) (Table 1 and S1 Table)
Summary
Multiple sclerosis (MS) is the most common chronic disabling disease of the central nervous system affecting young and middle aged adults with a typical onset age between 20 and 55 years. A large, multi-center study that evaluated different treatment strategies for people with treatment-resistant major depressive disorder (MDD) found that 20–30% of participants achieved a remission in depression by “switching” or “augmenting” their antidepressant medication. This study found that 21–27% of those randomized to the “switching” group and up to 20% of the “augmentation” group did not achieve remission from depression and had to discontinue the study because of intolerable side effects [5,6]. Remission can be achieved in a subset of MDD patients using these strategies, there are a considerable number of patients that do not tolerate “switching” or “augmenting” antidepressant medication.
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