Sankar Karthik, Mohathasim Billah Abdul Ajeed, Shanmugasundram Natrajan, Veintramuthu Sankar, Viswanathan Sushma
Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Chennai, IND.
Psychiatry, Sri Ramachandra Institute of Higher Education and Research, Chennai, IND.
Cureus. 2024 Jan 29;16(1):e53178. doi: 10.7759/cureus.53178. eCollection 2024 Jan.
Background Major depressive disorder (MDD) is a debilitating mood disorder that increases the risk of metabolic syndrome (MS), emphasizing the need for mental and physical health treatments. Although many studies have linked atypical antipsychotics to metabolic disturbances, there is limited evidence linking selective serotonin reuptake inhibitor use to MS. This study aimed to assess the risk of MS among patients with MDD who were administered vortioxetine and fluoxetine. Methodology This was a prospective, open-label, randomized controlled trial conducted in the psychiatry department. Using computer-generated random numbers, the physician assigned fluoxetine 20 mg or vortioxetine 10 mg and recorded MS parameters at baseline and each visit (4, 8, 12, 16, 20, and 24 weeks). This study was registered with CTRI (CTRI/2021/07/034892). Results A total of 122 participants were allocated randomly to the following two groups: group A (n = 60) and group B (n = 62). An independent-sample t-test showed a significant improvement in fasting plasma glucose (FPG) at week eight (p = 0.005), triglycerides (TGs) at week 16 (p = 0.005), high-density lipoprotein (HDL) at week 20 (p = 0.005), and waist circumference at week 24 (p = 0.005) in group A compared to group B. However, systolic blood pressure (SBP) and diastolic blood pressure (DBP) were not significantly associated with either group (p = 0.126 and p = 0.793, respectively). Overall depression remission (Hamilton Depression Rating Scale (HAM-D)) and medication adherence rating scale scores were similar between groups (p = 0.337 and 0.325, respectively). Furthermore, most adverse drug reactions were possibly associated with the study drugs. Conclusions In comparison to group B, group A showed significant improvements in FPG, HDL, and waist circumference more effectively; however, both groups led to higher TG levels, with non-significant numerical improvements observed in SBP and DBP in both groups. In addition, both treatment groups reduced the HAM-D score and had a similar MDD remission rate.
重度抑郁症（MDD）是一种使人衰弱的情绪障碍，会增加代谢综合征（MS）的风险，这凸显了对心理健康和身体健康治疗的需求。尽管许多研究已将非典型抗精神病药物与代谢紊乱联系起来，但将选择性5-羟色胺再摄取抑制剂的使用与代谢综合征联系起来的证据有限。本研究旨在评估接受伏硫西汀和氟西汀治疗的重度抑郁症患者发生代谢综合征的风险。
这是一项在精神科进行的前瞻性、开放标签、随机对照试验。医生使用计算机生成的随机数，分配20毫克氟西汀或10毫克伏硫西汀，并在基线和每次随访（第4、8、12、16、20和24周）记录代谢综合征参数。本研究已在印度临床试验注册中心注册（CTRI/2021/07/034892）。
总共122名参与者被随机分配到以下两组：A组（n = 60）和B组（n = 62）。独立样本t检验显示，与B组相比，A组在第8周时空腹血糖（FPG）（p = 0.005）、第16周时甘油三酯（TGs）（p = 0.005）、第20周时高密度脂蛋白（HDL）（p = 0.005）以及第24周时腰围（p = 0.005）有显著改善。然而，收缩压（SBP）和舒张压（DBP）与两组均无显著关联（分别为p = 0.126和p = 0.793）。两组之间总体抑郁缓解情况（汉密尔顿抑郁量表（HAM-D））和药物依从性评分量表得分相似（分别为p = 0.337和0.325）。此外，大多数药物不良反应可能与研究药物有关。
与B组相比，A组在空腹血糖、高密度脂蛋白和腰围方面有更显著的改善；然而，两组的甘油三酯水平均升高，两组的收缩压和舒张压虽有数值改善但不显著。此外，两个治疗组均降低了汉密尔顿抑郁量表得分，且重度抑郁症缓解率相似。
