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The goal of this prospective investigation was to study the course and the quality of patient-psychiatrist relationships during phase II / phase III clinical trials of antidepressant medication prescribed for depressive disorders. All patients who participated in the clinical trials (and subsequently in this survey) signed written informed consent statements and were subject to random double blind treatment assignment. Retrospective analysis of 118 investigations was carried out, and the patients involved were questioned concerning their experiences and impressions during and after the study. Data show that the outcome of clinical trials of antidepressant drugs are not a function of pre-existing good patient-psychiatrist relationships. On the other hand, no effects on the patient-psychiatrist relationship were found as a result of the experimental procedure, and it can be concluded that no detrimental effects on future patient-psychiatrist relationships were incurred.
In order to evaluate the incidence and risk factors of infection by hepatitis C virus (HCV) among injecting drug users (IDUs), we conducted a prospective cohort study of HCV- and human immunodeficiency virus (HIV)-negative IDUs in the North and East of France. A total of 231 HCV and HIV IDUs who had injected drugs at least once in their lifetime were followed up every 3 months over a 12-month period. Serum anti-HCV and anti-HIV were tested at inclusion in the study and at the end of the follow-up. Data on injecting practices were collected at inclusion and at each visit. Of the 231 participants included, 165 (71·4%) underwent a final HCV and HIV serum test. The incidence was nil for HIV infection and 9/100 person-years (95% CI 4·6–13·4) for HCV infection. In a multivariable analysis, we found that syringe and cotton sharing were the only independent predictive factors of HCV seroconversion.
La meta de esta investigación prospectiva era estudiar el curso y la calidad de las relaciones entre el paciente y el psiquiatra durante los ensayos clínicos de fase II y fase III de medicación antidepresiva prescrita para trastornos depresivos. Todos los pacientes que participaron en los ensayos clínicos (y posteriormente en esta investigación) firmaron declaraciones escritas de consentimiento informado y fueron sometidos a asignación aleatoria doble ciego al tratamiento. Se llevó a cabo un análisis retrospectivo de 118 investigaciones, y se interrogó a los pacientes implicados acerca de sus experiencias e impresiones durante el estudio y después. Los datos muestran que la evolución de los ensayos clínicos de medicamentos antidepresivos no está en función de que exista antes una buena relación entre paciente y psiquiatra. Por otra parte, no se encontraron efectos sobre la relación entre paciente y psiquiatra como resultado del procedimiento experimental, y se puede concluir que no se incurrió en efectos perjudiciales sobre futuras relaciones entre paciente y psiquiatra.
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