RESUMEN
The effects of single oral doses of 10 and 20 mg ebastine were compared with placebo and 2 mg clemastine in a double-blind cross-over study in 16 healthy male volunteers. Clemastine produced the known pattern of changes, namely impairment of psychomotor performance, drowsiness, and a selective effect on cognitive processes. Earlier encoding in a perceptual stage was slowed whereas abstract classification processes were not affected. Electrophysiological measures of vigilance showed a general decrease in vigilance especially 2.5 and 4.5 h after dosing. In contrast at no time was any effect of ebastine different from that of the placebo. Ebastine 10 and 20 mg differed positively from clemastine in its effect on pursuit tracking, subjective rating of drowsiness and general discomfort. Ebastine 10 mg also differed positively from clemastine in the EEG features of vigilance. It is concluded that 10 and 20 mg ebastine were free from sedative adverse effects.
Asunto(s)
Butirofenonas/farmacología , Clemastina/farmacología , Electroencefalografía/efectos de los fármacos , Antagonistas de los Receptores Histamínicos H1/farmacología , Piperidinas/farmacología , Desempeño Psicomotor/efectos de los fármacos , Adulto , Cognición/efectos de los fármacos , Método Doble Ciego , Humanos , Masculino , Valores de Referencia , Sueño/efectos de los fármacos , Encuestas y Cuestionarios , Vigilia/efectos de los fármacosRESUMEN
The influence on objective and subjective sleep variables and tolerance of lofepramine (140 mg) given as a single night time dose was compared with placebo in a double-blind cross-over study. Four healthy male volunteers on the same 2 nights of 2 consecutive weeks took either lofepramine or placebo in a randomized order. On 2 successive mornings of the third week all subjects took 140 mg lofepramine after breakfast. The main variables were electrophysiological measures of all night sleep. Supplementary, scores on a sleep questionnaire after each night, and scores on a side-effect questionnaire every morning and evening of the experiment were obtained. Lofepramine reduced paradoxical sleep and increased REM latency. There was a tendency for more intra-sleep restlessness but no relevant changes in sleep continuity variables. In these subjects lofepramine did not change subjective judgement of sleep quality and of feeling refreshed after sleep. No side-effects were reported.
Asunto(s)
Dibenzazepinas/farmacología , Lofepramina/farmacología , Sueño/efectos de los fármacos , Adulto , Humanos , Lofepramina/efectos adversos , Masculino , Proyectos Piloto , Fases del Sueño/efectos de los fármacos , Sueño REM/efectos de los fármacosRESUMEN
The combined effects of oxazolam (Tranquit), a benzodiazepine, and alcohol were examined in two separate studies. 20 healthy male student subjects participated in study I. 20 mg and 60 mg of oxazolam and placebo were combined with 0.55 g/kg alcohol and alcohol placebo. There were 3-4 subjects in each of the six cells of the 3 X 2 design. 102 healthy male employees of a company participated in study II. 20 mg of oxazolam and placebo were combined with 0.55 g/kg and 0.83 g/kg alcohol and alcohol placebo. There were 17 subjects in each of the six cells of the 2 X 3 design. In both studies achievement tests and subjective tests were applied before and after 90-120 min p.a. An analysis of covariance was used to evaluate the effects (pretest as covariate). The results in both studies showed definite effects of alcohol and only weak drug effects. All effects in the achievement tests pointed in a negative direction. In the few cases where alcohol and drug effects could be shown simultaneously, the effects added up in combination or the drug developed the negative effects of alcohol, which were not demonstrated under placebo alone. For the examined time of measurement the combined effects are comparable to the combined effects of other benzodiazepines.
Asunto(s)
Ansiolíticos , Benzodiazepinas , Benzodiazepinonas/farmacología , Emociones/efectos de los fármacos , Etanol/farmacología , Adulto , Atención/efectos de los fármacos , Electroencefalografía , Humanos , Masculino , Desempeño Psicomotor/efectos de los fármacosRESUMEN
The effects of imipramine (single dose of 100 mg orally) and lofepramine (single dose of 140 mg orally) in comparison to placebo on the EEG power spectra were examined in 24 non-selected healthy male volunteers. All subjects received the three drugs in a completely counterbalanced sequence. On the basis of their relative alpha-intensity the Ss were divided in two groups of 12 Ss each (high and low alpha-intensity). Two-way analyses of variance were computed for the absolute power in the alpha-, beta-, delta- and theta-frequency-bands. Imipramine increased the intensity of the delta-, theta- and beta-frequency-bands and decreased the power in the alpha-band. Lofepramine increased the intensity of the beta-band. The effects of imipramine and lofepramine are dependent on the relative power in the alpha-band of the Ss.
Asunto(s)
Ritmo alfa , Dibenzazepinas/farmacología , Electroencefalografía , Imipramina/farmacología , Adulto , Humanos , Masculino , Placebos , Factores de TiempoRESUMEN
Using 24 non-selected healthy male students the effects of imipramine (single dose of 100 mg orally) and 4'-chloro-2-[3-(10,11-dihydro-5H-dibenz[b,f]azepin-5-yl)-propyl]-methylamino]-acetophenone-hydrochloride (lofepramine, Gamonil) (single dose of 140 mg orally) in comparison to placebo (doubleblind) on subjective, physiological and performance variables were examined. All subjects (Ss) received the three drugs in a completely counterbalanced sequence. On the basis of their scores on the Depression Scale of the Freiburger Personality Inventory (FPI, Fahrenberg) Ss were divided into two groups of 12 Ss each, "high depression" and "low depression" group. Two-way analyses of variance were computed. Imipramine and Lofepramine elevate scores in the mood scale, but only for the "high depression" group. For the Ss scoring lower in depression no such effect can be demonstrated. The physiological effects are similar. Reported side effects are less for lofepramine than for imipramine.