A double-blind, randomised, controlled clinical trial of acetyl-l-carnitine vs. amisulpride in the treatment of dysthymia

Aim Evaluation of the effect of acetyl-l-carnitine (ALCAR) vs. amisulpride measured by total Hamilton Depression Rating Scale score (HAM-D₂₁) in patients with pure dysthymia (DSM IV). Two hundred and four patients were randomised and treated with ALCAR 500 mg b.i.d. or amisulpride 50 mg u.i.d. in a double-blind study, for 12 weeks. Results A solid improvement of HAM-D₂₁ was observed in both treatment groups throughout the study. The results did not disclose statistically significant differences between treatments, although the confidence interval for the non-inferiority of the primary end-point exceeded the pre-established limit of 2 by 0.46 points. According to a non-inferiority margin of 3 (considered acceptable by recent published data) the primary end-point could have been fully satisfied. CDRS, MADRS and CGI, employed to further measure the clinical outcome, reported similar results in both treatment groups. The greater tolerability of ALCAR is of clinical relevance considering the chronicity of dysthymia, which often requires prolonged treatment.