Efficacy and Safety of Acetyl-L-Carnitine and Agmatine Sulfate Compared to Escitalopram in Major Depressive Disorder: A Double-Blind Study

Background: To evaluate the efficacy and safety of FDC containing Acetyl-L-carnitine and Agmatine Sulfate versus Escitalopram in treating Major Depressive Disorder (MDD). Methods: Sixty participants, aged 18-65, diagnosed with MDD, were randomized to receive either FDC containing Acetyl-L-carnitine and Agmatine Sulfate or Escitalopram for 28 days. Depression severity was measured using the Hamilton Rating Scale for Depression (HAM-D17) and Montgomery-Asberg Depression Rating Scale (MADRS). Safety was assessed by monitoring adverse events and vital signs. FDC containing Acetyl-L-carnitine and Agmatine Sulfate significantly reduced HAM-D17 and MADRS scores more than Escitalopram (mean changes: -8.67 vs. -3.80 and -12.33 vs. -9.66, respectively). Adverse events were fewer in the FDC containing Acetyl-L-carnitine and Agmatine Sulfate group, with only one reported case compared to seven in the Escitalopram group. Conclusion: FDC containing Acetyl-L-carnitine and Agmatine Sulfate demonstrated superior efficacy and a better safety profile compared to Escitalopram, suggesting it as a promising alternative treatment for MDD. Further research is needed to confirm long-term benefits and optimal dosing.