Effect of Sertraline as an Add-on Therapy in T2DM Patients with Comorbid Depression: An Open Label Randomized Controlled Trial

OBJECTIVES: To study the effect of sertraline on depression in type 2 diabetes mellitus (T2DM) patients with comorbid depression. MATERIALS AND METHODS: An open label randomized control study. Patients with T2DM and moderate to severe depression were randomized to sertraline or control therapy for six months. The primary objective was the change in depression score and the secondary objectives were changes in glycemic parameters, wellbeing, and drug adherence scores at three and six months. RESULTS: The present study includes 160 T2DM patients with moderate to severe depression. Depression in these patients was evaluated using a self-reporting version of Patient Health Questionnaire (PHQ-9). A total of 80 patients each were randomized to sertraline and control groups. Sertraline significantly improved depression scores in patients with T2DM and moderate to severe depression both at 3 months and 6 months compared to the control group. The wellbeing and treatment adherence scores improved significantly in the sertraline group at 6 months. However, sertraline had no significant effect on glycemic parameters when compared to control group both at 3 months and 6 months. CONCLUSION: Sertraline significantly improves depression and drug adherence in T2DM patients with depression but has no effect on glycemic parameters.