Therapeutic Effects of Add-On Aceclofenac to Escitalopram in Patients with Depression: An Assessor-Blind, Randomized Clinical Study

Lower response and remission rates with current anti- depressants highlight the need for new treatment approaches in patients with depression. There is abundant literature suggesting non-steroidal anti-inflammatory drugs as an add-on therapy to improve outcomes in patients with depression. We investigated efficacy and safety of add-on aceclofenac alone and/or in-combination with serratiopeptidase to escitalopram in patients with depression. One-hundred and two patients with depression participated in randomized, assessor- blind, parallel group clinical study and underwent 12 weeks of treatment of following: a) add-on aceclofenac monotherapy (200mg/day) to escitalopram (20mg/day) a) add-on fixed-dose combination of aceclofenac and serratiopeptidase (200+30mg/ day) to escitalopram (20mg/day) c) escitalopram monotherapy (20mg/day). Efficacy measures included the 17-item Hamilton depression rating scale (HAM-D17) total score (primary end- point), Montgomery–Asberg depression rating score (MADRS) and biomarkers levels like interleukin-6, cortisol and brain- derived neurotrophic factor (BDNF). Repeated-measure analysis demonstrated significant effect for the product of time and treatment interaction on the HAM-D17 score for both above stated add-on study treatments to escitalopram (p<0.001). Patient receiving add-on aceclofenac monotherapy or its combination with serratiopeptidase to escitalopram have shown significant reduction in HAM-D17 score and MADRS score along with the decline (p<0.05) in IL-6 levels and cortisol levels at week 12. In addition, both add-on treatment groups to escitalopram have also shown significant improvement in BDNF levels as compared to escitalopram monotherapy group. The antidepressant activity of add-on aceclofenac monotherapy or its combination with serratiopeptidase to escitalopram might be linked to their capability of reducing IL-6 and cortisol concentrations along with significant rise in BDNF level.