ADHERE-DM: Assessing Bupropion for self-care adherence and glycaemic control in multimorbid type 2 diabetes mellitus with mild depression: A cross-over randomised controlled trial

Abstract

Type 2 diabetes mellitus (T2DM) and depression needs to be treated as an interconnected condition. Considering T2DM-related concerns amongst antidepressants, bupropion has a favourable metabolic profile including weight control, apart from a lower risk of sexual dysfunction. We studied the role of bupropion in patients with T2DM for ≥5 y and mild depression to assess effect on metabolic, self-care, and related parameters. This crossover RCT randomly assigned (1:1) participants with T2DM and antidepressant-naive mild depression to receive bupropion 150-mg once daily or standard care alone for three months, followed by a one-month washout period, the interventions were swapped for another three months. The co-primary endpoints were changes in HbA1c and self-care adherence, both of which had to be significant to claim benefit. 54 male patients with a mean±SD age of 50.9±7.7 y and HbA1c of 9.05±0.97% were recruited, with 27 each randomised to receive bupropion or standard care, each. Of these, 46 crossed over and 38 completed the study. HbA1c improved with both bupropion (-0.74%; 95% CI, -0.89 to 0.59) and standard care alone (-0.56%; -0.66 to -0.46), with an estimated treatment difference at endpoint of -0.06% (-0.34 to 0.22, P =0.69). Self-care adherence also improved with both bupropion (2.40 points; 1.87 to 2.93) and standard care alone (2.40 points; 1.93 to 2.86) with an estimated treatment difference at endpoint of -0.04 points (-0.93 to 0.85, P =0.93). There were no serious adverse events. Adding Bupropion to standard therapy for treatment of T2DM with mild depression, does not offer any benefit in terms of glycaemic control and self-care adherence.