EFFECT OF AGOMELATINE AND SERTRALINE ON PATIENTS WITH MAJOR DEPRESSIVE DISORDERS AND CHRONIC KIDNEY DISEASE: A RANDOMIZED CONTROLLED TRIAL

Abstract

Background: Depression is highly prevalent and is well known to affect patients with chronic kidney disease (CKD). Agomelatine exerts psychotropic effects upon mood and anxious states. There is limited data on agomelatine treatment among patients with CKD. Methods: Patients with CKD stage 3-5 with DSM-5-defined major depressive disorder (MDD) were randomly assigned to receive 25 mg/day of agomelatine or sertraline 50 mg/day for eight weeks at Phramongkutklao Hospital. Hamilton Depression Rating Scale (HDRS) score and concerning adverse events were measured at baseline and the end of the study. Efficacy assessment compared the improvements in clinical response and remission between the agomelatine and placebo groups. Results: Of 53 enrolled patients, 27 were assigned to the agomelatine group and 26 to the sertraline group. The mean age was 64.8±13.4 years. Baseline characteristics were comparable across treatment groups. After eight weeks, agomelatine-treated showed reductions in HDRS score from baseline (-15.6 with 95% CI -18.6 to -12.5). A significant difference was observed in the reduced HDRS scores between agomelatine and sertraline groups (-12.4; 95% CI -18.4 to -6.5). Over the 6-week treatment period, clinical response (55.0 vs. 9.0%, p <0.001) and remission (45.0 vs. 17.4%, p =0.049) improved significantly more with agomelatine than with sertraline. Both agomelatine and sertraline were well-tolerated during the treatment period. Conclusion: Agomelatine showed superior antidepressant efficacy over sertraline in treating CKD patients with depression after eight weeks, with a good tolerability profile.