[Open clinical study of the efficacy and safety of Halazepam in anxiety disorders]

Two open clinical studies were done to evaluate the therapeutic effectiveness and safety of Halazepam. These studies were carried out on an overall sampling of 81 somatic patients suffering from adaptive disorders and symptoms of anxiety, according to DSMIII criteria. The sampling was made up of 40 patients referred for general psychiatric consultation in the Ramón y Cajal Hospital (from any other medical or surgical department) and 41 cardiologic patients (both in- and out-patients). The mean age of the patients referred for general consultation was 40.0, and the mean age of the cardiologic patients was 55.5 years. The posologic standard was 20-120 mg/day, in a single dose or divided into several doses. The following clinical evaluation criteria were applied: Hamilton Anxiety Scale (HS), Physician Evaluation of Improvement (PhEI) and Patient Evaluation of Improvement (PaEI). To determine the safety of the medication, a modified Dotes Secondary Effects Scale was used. At the beginning of the study all the patients had scores of less than or equal to 18 on the Hamilton Depression Scale (HDS) and greater than or equal to 14 on the Hamilton Anxiety Scale. From the first week on till the end of treatment, a statistically significant improvement was observed, based on the scores of the different evaluation scales. Halazepam was found to improve the anxiety condition in 95.0% of the cardiologic patients and 92.5% of the general consultation group. All of the cardiologic patients and 87.5% of the general consultation ones completed the minimum study period (4 weeks) satisfactorily. The only undesirable effects observed were minor and short-lived, and it was not necessary to discontinue treatment in any of the cases. No changes were observed in the clinical significance of the analytic parameters monitored. The results of this study indicate that Halazepam is a fast, safe, effective and easy-to-use drug for treating anxiety.