RESUMO
This article presents results of monitoring of the recruitment process for a phase III study of a new antidepressant drug in elderly patients with depressive disorders, focusing on the peculiarities of recruitment posed by the presence of comorbidity and coadministration of medications. Data are derived from screening of 188 patients, the majority of whom lived at home, referred for trial inclusion. One hundred and seventy-one (91%) had Hamilton Rating Scale score in excess of 18 and met inclusion criteria. Only eight (4.2%) elderly depressed subjects could be recruited, after application of exclusion criteria. The trial data so obtained may be scientifically credible, but the conclusions reached by trials with very stringent exclusion criteria do not reflect the practice environment in which the product will be prescribed by clinicians. This raises questions of the relevance of good clinical research practice and good clinical practice guidelines to the reality of good clinical practice beyond the trial situation.
Assuntos
Ensaios Clínicos Fase III como Assunto/estatística & dados numéricos , Transtorno Depressivo/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa , Idoso , Antidepressivos/efeitos adversos , Antidepressivos/uso terapêutico , Transtorno Depressivo/diagnóstico , Transtorno Depressivo/psicologia , Método Duplo-Cego , Feminino , Humanos , Masculino , Seleção de Pacientes , Reprodutibilidade dos TestesRESUMO
Of 73 patients who met selection criteria to enter into a study on aggressive behaviour in schizophrenia, 11 patients (15.1%) did not participate. The participants and non-participants were similar in age, gender ratio and proportion who had aggressive behaviour. The participants, however, had a longer duration of illness, a longer duration of current admission, were more likely to suffer from residual schizophrenia, but less likely to suffer from disorganized schizophrenia and were less severely ill than the non-participants. These results indicate the need, in studies of aggressive behaviour in schizophrenia, to consider non-response bias as a confounding variable.
Assuntos
Agressão/psicologia , Projetos de Pesquisa , Psicologia do Esquizofrênico , Viés de Seleção , Adulto , Feminino , Humanos , Masculino , Estatísticas não ParamétricasRESUMO
The objective of this study was to determine whether extrapyramidal side effects of neuroleptics are associated with aggressive behaviour in schizophrenia. Thirty-one physically aggressive patients meeting DSM-III-R criteria for schizophrenia were compared with 31 matched non-aggressive patients in relation to their extrapyramidal side effects, including drug-induced parkinsonian (DIP) symptoms, akathisia and tardive dyskinesia. The aggressive group had significantly more severe DIP side effects than the non-aggressive group, but the association disappeared when level of psychopathology was controlled for. The aggressive group had more severe akathisia than the non-aggressive group, but the difference was not statistically significant. The two groups did not suffer in the severity of tardive dyskinesia. There was no significant, independent effect of extrapyramidal symptoms on aggressive behaviour in our sample of schizophrenic patients.