Effect of omega-3-fatty acids versus placebo on clinical symptoms of patients with major depressive disorder: a double blind randomized clinical trial

Objectives: To assess the effect of omega-3-fatty acids versus placebo on clinical symptoms of patients with major depressive disorder. Design: A double blind randomized clinical trial. Setting and conduct: The eligible patients with major depressive disorder who will refer to Sina Hospital during the study period will be enrolled into the trial. Inclusion criteria: Age of 18 to 65 years; major depressive disorder Exclusion criteria: Pregnancy or breastfeeding; narcotic addiction; psychosis. Intervention group: Routine treatment plus omega-3 capsule 100 mg daily for 12 weeks. Control group: Routine treatment plus placebo capsule daily for 12 weeks Primary outcome: (a) depressive symptoms using standard questionnaire before intervention and 6 and 12 weeks after intervention; (b) sleep disorder using standard questionnaire before intervention and 6 and 12 weeks after intervention; (c) social competencies using standard questionnaire before intervention and 6 and 12 weeks after intervention; (d) physical activity using standard questionnaire before intervention and 6 and 12 weeks after intervention; (e) cognitive performance using standard questionnaire before intervention and 6 and 12 weeks after intervention. Randomization: Random assignment of the patients to the intervention and control groups using random number table. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.

Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences