THE EFFECT OF FOLIC ACID SUPPLEMENTATION ON PLASMA HOMOCYSTEINE LEVELS: A DOUBLE-BLIND, PLACEBO-CONTROLLED RANDOMIZED TRIAL ON PATIENTS

Major depression is a mood disorder and the most common psychological disorder. As consistent findings in the major depressive disorder (MDD) denote for a low plasma folate and elevated plasma homocysteine concentration s; the results of studies are controversary. In addition, there has been no previous investigation on the effects of administration of folic acid on plasma homocysteine levels in patients, so the present study aimed to assess the effect of folate supplementation plasma homocysteine levels in patients with major depressive disorder. This study was a double-blind, placebo-controlled trial of 70 MDD patients that were randomly assigned to receive fluoxetine together with either 1 mg folic acid or an identical looking placebo daily for 8 weeks. All patients met the DSM-IV criteria for major depression and had a baseline Hamilton rating scale score of 20 or more. Baseline and 8-week estimations of plasma folate and homocysteine levels were determined by kits and with radioimmunoassay method and Enzyme Immunoassay method. The statistical analysis was conducted with the software package SPSS 11.5 and by paired t-test, independent t-test, and chi-square. Correlations were performed using Pearson’s correlation coefficient. The results of the present study indicated that after 8 weeks, supplementation plasma homocysteine significantly decreased in women by 32%, (p=0.001) but there was no significant change in men. According to Hamilton rating scale women who received the folic acid supplement, showed a good response as compared to women in placebo group (P<0. 05) but there was no significant difference in treatment response between the men of two groups. According to Hamilton rating scale 88.9 percent of women in case group showed a good response (50% reduction in score) as compared to 59.3% women in placebo group (P<0. 05) but there was no significant difference in treatment response between the men of two groups. These finding suggest that Folic acid supplementation is a simple method for decreasing plasma homocysteine levels.