RESUMEN
The present double-blind, placebo-controlled study evaluates the effects of agomelatine and the selective serotonin reuptake inhibitor escitalopram on sexual dysfunction in healthy men and women. METHODS: A total of 133 healthy volunteers (67 men, 66 women) were randomly assigned to agomelatine (25 or 50 mg) or escitalopram (20 mg) or placebo for nine weeks. Sexual acceptability was evaluated by using the psychotropic-related sexual dysfunction questionnaire 5-items total score and sexual dysfunction relative to each sub-score (in 110 volunteers with sexual activity). Sexual dysfunction was evaluated at baseline and after two, five and eight weeks of treatment and one week after drug discontinuation. RESULTS: The psychotropic-related sexual dysfunction questionnaire 5-items total score was significantly lower in both agomelatine groups versus escitalopram at all visits (p < 0.01 to p < 0.0001) with no difference between agomelatine and placebo nor between both agomelatine doses. Similar results were observed after drug discontinuation. The total score was significantly higher in the escitalopram group than in the placebo group at each post-baseline visit (p < 0.01 to p < 0.001). Similar results were observed regardless of volunteers' gender. Compared to placebo, only escitalopram significantly impaired dysfunction relative to "delayed orgasm or ejaculation" (p < 0.01) and "absence of orgasm or ejaculation" (p < 0.05 to p < 0.01). The percentage of participants with a sexual dysfunction was higher in the escitalopram group than in agomelatine groups (p < 0.01 to p < 0.05) and placebo (p < 0.01). CONCLUSION: The study confirms the better sexual acceptability profile of agomelatine (25 or 50 mg) in healthy men and women, compared to escitalopram. TRIAL REGISTRATION NAME: Evaluation of the effect of agomelatine and escitalopram on emotions and motivation in healthy male and female volunteers. TRIAL REGISTRATION NUMBER: ISRCTN75872983.
Asunto(s)
Acetamidas/administración & dosificación , Citalopram/administración & dosificación , Hipnóticos y Sedantes/administración & dosificación , Inhibidores Selectivos de la Recaptación de Serotonina/administración & dosificación , Disfunciones Sexuales Psicológicas/tratamiento farmacológico , Adulto , Método Doble Ciego , Emociones/efectos de los fármacos , Femenino , Voluntarios Sanos , Humanos , Masculino , Escalas de Valoración Psiquiátrica , Encuestas y Cuestionarios , Adulto JovenRESUMEN
Psychomotor retardation, especially motor and cognitive slowing down, has been described many times in the elderly but to our knowledge, has never been examined in healthy middle-aged adults. The present study explores whether walking time may provide an early signal of cognitive performance, using 266 healthy adults ([18-65] years old, mean age: 45.7±12.9 years) who were also subdivided in 2 groups: under or over 50. Walking time (50 meters) and cognitive performances (mini-mental state examination, Benton Visual Retention Test and Rey Complex Figure) were assessed; total psychometric score was the sum of individual test scores. Analyses were controlled for age, gender, education level, height and weight. The mean psychometric scores were within the normal range. A substantial proportion of subjects exhibited low performance in some aspects of visuospatial memory, particularly in the older subset. In the total population, walking time was negatively correlated with all cognitive tests, particularly to total psychometric score (Râ=â-0.817, p<0.0001); the unique contribution of walking time on all cognitive scores was very high (delta R-squaredâ=â0.496). In the older subset, performances on walk and cognition were lower than in the younger subset. Total psychometric score showed the strongest correlation with walking time in the older subset (Râ=â-0.867; p<0.001). In all subsets, walking time was the main explanatory variable of the total psychometric score (delta R-squared: ≤ 49â=â0.361; ≥50â=â0.613). These findings indicate that i) a significant proportion of adults without cognitive complaints exhibit low cognitive performance including visuospatial memory and longer walking time, ii) cognitive functioning is strongly correlated to walking time in healthy middle-aged adults, iii) gait velocity (GV) could be an indicator of cognitive performance in some important cognitive domains. These results warrant further investigation because such data may represent a marker for the detection of middle-aged adults who are at risk for further cognitive decline.