A prospective, randomized, open-label study to compare the different dosage forms of omega 3 fatty acids as an adjuvant in the bipolar depression

Background: Bipolar affective disorder is a chronic disorder in which bipolar depression (BD) has poor prognosis than mania. There is a lack of universal pharmacotherapy for BD, with standard drug therapy having multiple long term adverse effects. Omega-3 fatty acids (O3FAs) act on key BD pathology and found to have reduction on symptom severity in BD. Thus, this study aims to compare efficacy and safety of 2 different doses, 1.2 g/day and 2.4 g/day of O3FAs with control group in BD patients. Methods: This is an interventional, randomized, open-label, prospective and parallel study of 12 weeks with patients (n=90) randomly divided into three groups. This study compared the control group (Group A, n=30) on standard drugs only, with 1.2 g/day OD of O3FAs (Group B, n=30) and 2.4 g/day BD of O3FAs (Group C, n=30). Evaluation of efficacy was done on basis of Hamilton Depression Rating Score (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impression (CGI) scales every 15 days for 3 months. Adverse effects were reported every 15 days for 3 months. Results: After 3 months of treatment, Group C had statistically significant improvement in HAM-D (p<0.01), MADRS (p<0.01) and CGI (p<0.01) scores as compared to group A and B. Group A (37) had of adverse effects than Group B (21) and C (17) at 3 months. Conclusions: Group C seems to had better efficacy and safety as compared to Group B and baseline drugs alone. Further extensive research with large sample size and studies with longer duration are required to validate the role of O3FAs in BD.