A double-blind cross-over evaluation of the activity of d-oxazepam hemisuccinate sodium salt (D-7-chloro-1,3-dihydro-3-hemisuccinyloxy-5-phenyl-2H-1,4-benzodiazepine-2-one) compared to its racemic form.

After carrying out a pilot study on D-7-chloro-1,3-dihydro-3-hemisuccinyloxy-5-phenyl-2H-1,4-benzodiaze-pine-2-one (D-oxazepam hemisuccinate sodium salt) (+), the authors examined in the present study the anxiolytic effects of this drug in comparison to its racemic form (+/-). The modifications of the symptoms were measured by the rating scale for anxiety (R.S.A.S.) of Hamilton and the experiment was carried out according to a cross-over, double-blind design. 34 patients hospitalized in the Psychiatric Hospital of Marzana (Verona) were studied. These patients complained of different syndromes but each of them had anxiety as the main symptom. The results obtained, evaluated clinically and statistically, confirm what was previously reported on the activity of D-oxazepam hemisuccinate sodium salt. In synthesis the drug given at a daily dose of 100 mg i.m. acts favourably upon: sleep disturbances, anxiety states and tension, somatic symptoms associated with anxiety. Given in equal doses both substances, dextrorotatory and racemic forms, act upon the same parameters of anxiety (as reported above). It has a superior activity over the racemic form, as it can be seen by the comparison of the variations of the general symptomatology and the single items particularly in the 2nd cycle of treatment.

RCT Entities:   Population Interventions Outcomes