Safety and Efficacy of Add on Modafinil to Selective Serotonin Reuptake Inhibitors in Major Depressive Disorder.

Aim: Despite the efficacy of selective serotonin reuptake inhibitors (SSRIs) in the treatment of major depression, a significant number of patients show partial or no remission of symptoms. Although antidepressant medications are effective, they have a delayed onset of therapeutic effect. Modafinil is a novel psychostimulant that may be helpful in treating patients with residual symptoms of depression. The efficacy of modafinil as add-on therapy to SSRIs in depressed patients in Indian population is lacking; hence this study was designed to study the efficacy and safety of Modafinil as add-on therapy to SSRI in depressed patient in Indian Population.Methods: In an open, randomized study, 50 patients diagnosed with major depressive disorder (MDD) were divided into two groups. In Group A (n = 25) patients received conventional SSRIs with low dose Modafinil for 8 weeks. In Group B (n = 25) patients received conventional SSRIs for 8 weeks. Patients were evaluated at baseline and then at the end of 2, 4, 6, and 8 weeks. Results: There was significant improvement in Hamilton depression rating scale (HDRS), Epworth Sleepiness Scale (ESS), Fatigue severity Scale (FSS) and Clinical Global Improvement – severity (CGI-S) Scale (p < 0.05) in both groups. Modafinil in low dose as add on therapy showed more decrease in scores, had earlier onset of action, as compared to conventional treatment (p < 0.05). No serious adverse event was reported in either of the groups. Conclusion: Low dose Modafinil as add-on therapy had shown better efficacy, earlier onset of action as compared to conventional treatment in MDD in Indian patients.