In the case of antidepressants, this issue has not been subjected to a comparative, randomized trial since approval of the first antidepressant drugs over 30 years ago. This is a formidable obstacle for clinical practice that is not likely to be resolved within the current system of clinical trials. Refractory cases are also rarely studied. Withdrawal syndromes and their care are similarly neglected. Basic information necessary to exercise sound clinical judgment is often not available.
Clinical trials report results in terms of statistical rather than clinical significance.
Without knowing the proportion of patients restored to good social and vocational function, as well as symptomatic decrease, doctors cannot ascertain the clinical utility of the findings. This discussion is not an attempt to question FDA standards of safety and efficacy. It may be possible to institute some of these changes within the current system. Longer Phase II trials addressing maintenance questions should be carried out concurrently with Phase III trials. If the benefits of the drug are not sustained, this would avoid the cost of continuing Phase III trials.