What Happens to Patients After the End of a Clinical Trial?

Abstract

I Controlled clinical drug trials typically last several weeks. At the end of this fixed time period approximately two-thirds of the patients in trials with antidepressant drugs are classified as responders, i. e. the initial severity score is reduced by about fifty percent. In a clinical perspective this means that many patients, even among the responders, are still quite ill and require further treatment. Nevertheless, to date there do not appear to have been any studies on treatment and course of illness after the termination of controlled clinical trials. In a "naturalistic" follow-up surveillance study of 202 patients who had taken part in a controlled trial with the antidepressant moclobemide for six weeks, treatment and clinical status were monitored through questionnaires sent out to their treating physicians (n = 78) at two assessment points four weeks and six months later. Results showed that sixty percent of patients continued to receive the study drug moclobemide after the completion of the clinical trial. Twenty percent were switched to other antidepressants and twelve percent received no further psychotropic drugs. In the course of six months a considerable variation in treatment modes could be observed. Patients under ongoing active treatment made considerable additional progress. A correlation was found between insufficient response and repeated switching of medication. Patients who had been taken off antidepressant medication because of early good response did not experience early relapse after the end of treatment.