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Nowhere patients
17 April 2012
Journal of Psychotherapy and Psychosomatics
In the current issue of Psychotherapy and Psychosomatics Elena Tomba (University of Bologna) analyses the literature concerned with drug treatment of depression. She notes that virtually all studies ignore the clinical history of patients.
Today, most of the clinical activities are concentrated on chronic disease or non-disease-specific complaints. Yet, the standard randomized controlled trial design is still based on the acute disease model and ideally evaluates therapeutic effects in untreated patients who have a recent acute onset of their disturbances. This is in sharp contrast with the fact that particularly in psychopharmacology, the patient is likely to have experienced other treatments before and these treatments may actually modify the course and responsiveness of the individual patient. From a clinical viewpoint, it is quite different to treat a patient with a major depressive episode who displayed positive responses to previous therapeutic trials and a patient who failed to respond to various adequate trials. These failed trials may have both neurobiological and psychological consequences. In neurobiological terms, phenomena such as the oppositional model of tolerance may become operational. In psychological terms, patients may interpret unfulfilled expectations about therapy as an indication that their symptoms were worse than originally thought. The mechanisms may be particularly pronounced with overselling the efficacy of treatment (the violation of expectation). There is limited awareness of the limitations of the traditional randomized controlled trials and few suggestions for alternative models have been made. An adaptive treatment strategy has been recently developed for adjusting a treatment plan to the changing status of an individual patient, taking into account both the history of previous treatments and the response to those treatments. Another design involves the sequential model, i.e. the sequential combination of treatments, such as psychotherapy after pharmacotherapy in depression. Therapeutic targets are not predetermined, but depend on the response of patients to the first course of treatment. The sequential model design allows to randomize patients who are already in treatment and to assign them to treatment alternatives according to stages of development and individual history and not simply to disease classification.
The clinical history of 3 patients is described and illustrates the clinical implications of these methodological choices. Under ordinary conditions, these patients would all be eligible to be included in the same trial regardless of their treatment history. The heterogeneous features of these nowhere patients would then affect the outcome of the trial. Meta analyses of these nowhere groups of patients may amplify the heterogeneous nature of the patient populations, particularly if random effects models were endorsed and trials had different rates of participation. Should treatment research in depression aim for large heterogeneous trials of nowhere patients or should we aim for small trials with very well defined treatment history? Should we limit observation to a month in the life of a patient or should we extend it to more prolonged periods of time? Should we limit assessment to the customary methods and symptoms, with their ensuing categorical definitions of remission, or expand assessment with broader strategies that have emerged in recent years?
These issues appear to be crucial for making true progress in depression treatment research.