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

Abstract

Objective: Major depressive disorder (MDD) is predicted to be the first cause of burden of disease. The antidepressant activity of gemfibrozil has been recently considered. This study was designed to evaluate the effectiveness of gemfibrozil as a sertraline adjunct in treating patients with MDD.

Method: A total of 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 randomized to receive either 300 mg daily gemfibrozil or placebo in addition to 100 mg sertraline for 8 weeks in a randomized, double-blind placebo-controlled trial. Patients were evaluated for response to treatment using the HAM-D score at baseline and weeks 2, 4, and 8.

Results: Forty-five patients completed the study and took part in all 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 significant difference was seen in time [p–value < 0.001]. The test of between-subject effects also showed a significant effect of treatment on HAM-D scores at weeks 2, 4, and 8 [p–value = 0.07]. Using KaplanMeier estimate curves, time to remission periods were significantly different between the 2 trial arms [Log-Rank p–value = 0.003].

Conclusion: Gemfibrozil is an effective adjunctive treatment in MDD and can be used to reduce depression symptoms.