A clinical trial comparing sustained release amitryptyline (Saroten Retard) and conventional amitriptyline tablets (Saroten) in endogenously depressed patients with simultaneous determination of serum levels of amitryptyline and nortriptyline.

The clinical effect of a sustained release preparation of amitriptyline has been compared with that of conventional amitriptyline tablets in a double-blind cross-over study with 24 patients suffering from endogenous depression. The sustained release preparation was given in a single evening dose (9 p.m.) of two thirds the total daily dose of conventional tablets, which was given in a three times-a-day regimen (8 a.m., 12 a.m. and 9 p.m.). Serum concentrations of amitriptyline and its active metabolite, nortriptyline, were determined. No difference was found between the two preparations as regards either clinical effect or side effects. No correlation could be shown between the clinical effects and the serum concentrations of amitriptyline and nortriptyline.

RCT Entities:   Population Interventions Outcomes