Agomelatine versus fluoxetine in glycemic control and treating depressive and anxiety symptoms in type 2 diabetes mellitus subjects: a single-blind randomized controlled trial

Abstract

BackgroundDepressive and anxiety symptoms could seriously affect the quality of life of type 2 diabetes mellitus (T2DM) subjects. Currently, little is known about the efficacy and acceptability of agomelatine versus fluoxetine in treating these symptoms in T2DM subjects. Therefore, this study was performed to find out which one was better in treating these symptoms in T2DM subjects.Materials and methodsT2DM subjects with depressive and anxiety symptoms were randomly assigned to receive either fluoxetine (30–40 mg/day) or agomelatine (25–50 mg/day). The treatment was continued for 12 weeks. The data of the Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Rating Scale (HARS) were collected (at baseline and also at weeks 4, 8 and 12) to assess the depressive and anxiety symptoms, respectively. The metabolic parameters, including body mass index (BMI), fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c), were assessed at baseline and after 12 weeks of treatment. The treatment-related adverse events during the scheduled treatment period were recorded to compare the acceptability of these two drugs.ResultsAfter 12 weeks of treatment, the average HDRS and HARS scores were significantly decreased in both groups. The average HDRS scores were not significantly different between the two groups, although the agomelatine group had a lower average HDRS score. The response and remission rates were similar between the two groups, and these two drugs had no significant effects on BMI and FPG. However, compared with the fluoxetine group, the agomelatine group had the significantly lower average HARS score (p=0.0017) and lower average HbA1c level (p<0.00001). Moreover, the incidence of adverse events was significantly lower in the agomelatine group than in the fluoxetine group (p=0.032).ConclusionBoth fluoxetine and agomelatine could effectively reduce depressive and anxiety symptoms in T2DM subjects, but agomelatine might be more effective and acceptable. Future studies with more subjects are needed to support and validate our conclusion.

Risk and protective factors of co-morbid depression in patients with type 2 diabetes mellitus: a meta analysis

“…Depression can conduct to a worse diabetes control, lower adoption to treatment, and increased economic burden of health care costs, besides depressive symptoms could seriously affect the quality of life of T2DM subject [6]. One study indicated that individuals with depressive symptoms are three times more likely to exhibit decreased adherence [7].…”

Treatment for comorbid depressive disorder or subthreshold depression in diabetes mellitus: Systematic review and meta‐analysis

“…One RCT (Guo et al., 2014) found that metformin improved glycemic control but also depressive outcomes, compared to placebo, in patients with type 2 diabetes. Although a small study with only 58 participants, this finding is of interest and may contribute to the expanding field of evaluation of medicines that are normally prescribed for physical conditions for their effect in treatment of depression (Arteaga‐Henríquez et al., 2019; Che et al., 2018; Köhler et al., 2014). Further research could explore the mechanism for metformin in improvement of depression in diabetes.…”

Efficacy of betahistine plus cognitive behavioral therapy on residual dizziness after successful canalith repositioning procedure for benign paroxysmal positional vertigo

“…The repeated-measures ANOVA was conducted to explore the group differences on DHI, HDRS, and HARS scores at four time points (at baseline and at weeks 1, 2, and 4). 27 The criterion for statistical significance was set at P <0.05, and all analyses were conducted using SPSS 19.0 (IBM Corporation, Armonk, NY, USA).…”