Addition of eicosapentaenoic acid to maintenance anti-depressant therapy in diabetes patients with major depressive disorder: a double-blind, placebo-controlled pilot study.

Depression can be regarded as a common threat to the quality of life of diabetes patients. Evidence strongly suggests that major depression is more prevalent and more persistent in diabetes patients compared to the general population. Depression in diabetes is also associated with impaired glycaemic control, an increased risk for cardiovascular complications and increased health care consumption. Effective pharmacological interventions are available to treat major depression. Yet, in only 50-60% of the depressed subjects with diabetes, pharmacotherapy does lead to remission of depression.

Both depression and diabetes were found to be associated with an impaired fatty acid metabolism. Several animal and epidemiological studies have found that consumption of omega-3 fatty acids is associated with a decreased risk for depression. Three randomised controlled trials in non-diabetic subjects demonstrated that omega-3 fatty acids as add-on therapy is effective in treating major depression, whereas one trial found that monotherapy with docosahexaenoic acid is not. So far, interventions in diabetes patients are lacking. The omega-3 fatty acids have three main advantages: 1) they are relatively inexpensive, 2) generally well tolerated by patients and 3) decrease the risk of cardiovascular disease. The available evidence warrants a trial with omega-3 PUFA in particular in the diabetic population, that has a high prevalence of treatment-resistant depression.
The currently proposed randomised double-blind, placebo-controlled pilot add-on study will be the first to test this hypothesis in diabetes patients suffering from current major depression and to determine underlying physiological mechanisms.

Addition of eicosapentaenoic acid (1 gram/day) to maintenance anti-depressant therapy in diabetes patients and major depression will be associated with a reduction of depression symptoms, compared to placebo (1 gram grapeseed oils).

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2 capsules containing eicosapentaenoic acid (total amount of 1 gam/day) or placebo.