EFFECT OF AGOMELATINE AND SERTRALINE ON SLEEP QUALITY AMONG PATIENTS WITH CHRONIC KIDNEY DISEASE AND MAJOR DEPRESSIVE DISORDER: A DOUBLE-BLINDED RANDOMIZED CONTROLLED TRIAL
Keywords:Chronic kidney diseases, Depression, Sleep quality, Clinical trial, Agomelatine, Sertraline
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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