[Clinical evaluation of oxypertine in anxiety conditions]

Abstract

Oxypertine, a new anxiolytic drug related to the indolylazine compounds, was evaluated in a group of 30 patients, the majority with severe anxiety (acute or chronic) : in some cases depression was associated. The study was performed in the Psychiatric Department at the Centro Femenil de Rehabilitación Social, in Mexico City. A special feature of this study was that patients were confined for a legal process and consequently with restricted liberty. All were females between 19 to 44 years old, with an average age of 32.05 years. The methodology applied in this case was a modified double blind randomized procedure, using different color capsules with placebo or the active drug (yellow oxypertine and blue placebo). Patients received a 10 mg capsule every 12 hours (20 mg daily). The clinical measurement of anxiety was performed using the Visual Anxiety Scale (Murphy), evaluating each of its 11 parameters. The intensity was qualified from 0 to 3; at the end of each consultation a global assessment was made. Most of the patients were interviewed in five occasions during the treatment period. For each of the nine patients receiving during 4 weeks only oxypertine capsules (group I), the scores of the parameters of the scale were added, observing the following results: in seven excellent respond, fair in one and one abandoned the study since the beginning. In eight of the patients who received placebo (group II) also for a 4 weeks period, results were evaluated as follows: five excellent one good and two poor. It can be observed that both groups gave a similar final score at the end of the study, meaning that no significant benefits were obtained between the active drug and the placebo, in spite that anxiety decreased in most of them. In group III, seven cases initiated with placebo and after 2 weeks the capsule had to be changed to oxypertine due to stablization or increase in the anxiety. Results were excellent in three, good in two, poor in one and another case suspended the treatment when placebo was to be substituted. In this same group, six cases initiated treatment with oxypertine, and after two weeks or more the medication was changed to placebo due to the same reasons mentioned above. Results were fair in one and poor in five. A significant response was observed in those cases where oxypertine replaced placebo and no response was obtained when placebo substituted oxypertine. Few cases abandoned mainly for two reasons: satisfactory remission of the anxiety or symptoms exacerbation. Investigators emphasize that the psychological conditions of the patients studied in this trial were different from the ones who ordinarily assist to the out patient clinics or private practice, mainly because were subjects with legal and social problems, as already mentioned, confined in a rehabilitation center. The conclusion of the stldy is that the administration of oxpertine at the dosage of 20 mg to patients with severe anxiety and with the special conditions mentioned above, provides a relative anxiolytic effect.