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.
Background: Depression is a common comorbid disease among patients with chronic kidney disease (CKD). Insomnia, a symptom related to these conditions, negatively impacts disease progression and quality of life. Unfortunately, no consensus has been reached concerning treatment guidelines and choices of antidepressants suitable for treating depression among patients with CKD.
Objectives: The study aimed to evaluate the efficacy to sleep quality, depressive symptoms, safety and tolerability of agomelatine and sertraline in treating major depressive disorder among patients with CKD.
Methods: A double-blinded randomized controlled trial was conducted in the Nephrology Unit, Department of Medicine, Phramongkutklao Hospital, Bangkok, Thailand. Patients with CKD and a diagnosis of major depressive disorder were randomly assigned to receive once-daily, fixed-dose sertraline 50 mg/d and agomelatine 25 mg/d. The treatment outcome was evaluated at 4 and 8 weeks. The Pittsburgh Sleep Quality Index score (PSQI) was used to measure sleep quality, and the Hamilton rating scale of depression, the Thai version (Thai HRSD-17), was used to evaluate depressive symptoms. Other outcomes included overall quality of life, side effects and tolerability.
Results: Agomelatine significantly improved sleep quality based on PSQI score throughout the observed period (p=0.002). Also, agomelatine more efficiently reduced depressive symptoms than sertraline (p=<0.001). In addition, patients receiving agomelatine as a treatment could continue their medication, whereas 52% of patients receiving sertraline discontinued because of side effects.
Conclusion: Agomelatine significantly improved sleep quality and tolerated well compared to sertraline.
Trial registration: thaiclinicaltrials.org ID: TCTR20200319005
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