Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India
Department of Endocrinology & Metabolism, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
BMJ Open. 2024 Jun 4;14(6):e077975. doi: 10.1136/bmjopen-2023-077975.
Diabetes and depression are among the 10 biggest health burdens globally. They often coexist and exhibit a strong bidirectional relationship. Depression leads to decreased adherence to self-care activities. This impacts glycaemic control and worsens type 2 diabetes mellitus (T2D). Both conditions have a synergistic effect and lead to greater complications, hospitalisations, healthcare expenditure and a worse quality of life. There is no consensus on managing people with comorbid T2D and depression. Bupropion is an efficacious antidepressant with many properties suitable for T2D with depression, including a favourable metabolic profile, persistent weight loss and improvement in sexual dysfunction. We will assess the efficacy and safety of add-on bupropion compared with standard care in people with T2D and mild depression. This study can give valuable insights into managing the multimorbidity of T2D and depression. This can help mitigate the health, social and economic burden of both these diseases.
This cross-over randomised controlled trial will recruit people with T2D (for 5 years or more) with mild depression. They will be randomised to add-on bupropion and standard care. After 3 months of treatment, there will be a washout period of 1 month (without add-on bupropion while standard treatment will continue). Following this, the two arms will be swapped. Participants will be assessed for glycosylated haemoglobin, adherence to diabetes self-care activities, lipid profile, urine albumin-to-creatinine ratio, autonomic function, sexual function, quality of life and adverse events.
The Institutional Ethics Committee at All India Institute of Medical Sciences, Jodhpur has approved this study (AIIMS/IEC/2022/4172, 19 September 2022). We plan to disseminate the research findings via closed group discussions at the site of study, scientific conferences, peer-reviewed published manuscripts and social media.
CTRI/2022/10/046411.
糖尿病和抑郁症是全球十大健康负担之一。它们常常同时存在，并表现出强烈的双向关系。抑郁症导致患者对自我护理活动的依从性降低。这会影响血糖控制，并使 2 型糖尿病（T2D）恶化。这两种情况具有协同作用，会导致更多的并发症、住院、医疗支出和更差的生活质量。对于同时患有 T2D 和抑郁症的患者，目前尚无共识来管理。安非他酮是一种有效的抗抑郁药，具有许多适合伴抑郁的 T2D 的特性，包括有利的代谢谱、持续的体重减轻和改善性功能障碍。我们将评估添加安非他酮与标准护理相比，在 T2D 伴轻度抑郁患者中的疗效和安全性。这项研究可以为管理 T2D 和抑郁症的合并症提供有价值的见解。这有助于减轻这两种疾病的健康、社会和经济负担。
这是一项交叉随机对照试验，将招募 T2D（患病 5 年或以上）伴轻度抑郁的患者。他们将被随机分配到添加安非他酮和标准护理组。治疗 3 个月后，将有 1 个月的洗脱期（不添加安非他酮，同时继续标准治疗）。之后，两组将进行交换。参与者将接受糖化血红蛋白、糖尿病自我护理活动依从性、血脂谱、尿白蛋白/肌酐比值、自主神经功能、性功能、生活质量和不良事件的评估。
全印度医学科学研究所（AIIMS）的机构伦理委员会已批准这项研究（AIIMS/IEC/2022/4172，2022 年 9 月 19 日）。我们计划通过在研究地点的小组讨论、科学会议、同行评议的已发表论文和社交媒体来传播研究结果。
CTRI/2022/10/046411。
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