Efficacy of Gemfibrozil as an Adjunct to Sertraline in Major Depressive Disorder, A Double-Blind, Randomized, and Placebo-Controlled Clinical Trial

Objective: Major depressive disorder (MDD) is predicted to be one of the biggest disease burden in the future. The antidepressant activity of gemfibrozil has been recently considered. In this study, we assessed the effectiveness of gemfibrozil as a sertraline adjunct in treating patients with MDD. Method : In this study, 46 patients with MDD based on the DSM-V criteria with a minimum score of 22 on the 17-item Hamilton Rating Scale for Depression (HAM-D) were divided into two groups. One group was treated with 300 mg of gemfibrozil daily and the other group treated with placebo. Each group was treated simultaneously with 100 mg of sertraline daily for 8 weeks. The trial was randomized and double-blind. To assess the response to treatment, patients were evaluated at baseline and then at weeks 2, 4 and 8 using the HAM-D score. Results: The study was completed by 45 patients up to the final stages and follow-up visits. Repeated measure ANOVA with a Greenhouse-Geisser correction showed a significant difference for time×treatment interaction on within-subjects HAM-D scores [p–value= 0.026]. A notable difference was seen in time [p–value < 0.001]. The test of between-subject effects also represented a remarkable consequence of treatment on HAM-D scores at weeks 2, 4, and 8 [p–value = 0.07]. Using Kaplan-Meier estimate curves, time to remission periods were notable different between the 2 trial groups [Log-Rank p–value = 0.003]. Conclusion: Gemfibrozil is an effective adjunctive treatment in MDD and can be used to reduce depression symptoms.