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The purpose of this study is to explore how psychological factors may affect research subjects' observed response to experimental treatment
and, more specifically, to investigate whether subjects' knowing they are receiving an active medication affects response rates to antidepressants in clinical trials.
Over a century ago, Freud recognized the potential influence of patients' treatment-related beliefs and expectations on their response to psychoanalysis, and he took pains to differentiate his results from such “suggestion.” In the “Preliminary Communication” (Freud and Breuer 1893) he phrased this possible interpretation of observed treatment effects: “the patient expects to be relieved of his sufferings by this procedure, and it is this expectation … which is the operative factor” (p. 7). Psychotherapy researchers later picked up on this thread. For example, Jerome Frank (1961) famously discussed how “a patient's expectancy of benefit from treatment in itself may have enduring and profound effects upon his mental state” (p. 36). Later investigators enumerated other nonspecific treatment factors, including chance variation, spontaneous remission, health care provider attention, treatment credibility and rationale, persuasion, clinician allegiance effects, and experimental demand characteristics (Lohr, DeMaio, and McGlynn 2003).
In contrast, the fact that patients in research studies have been informed they are in an experiment and are likely to develop conditionspecific expectancies about whether or not they will improve has been largely ignored by pharmacotherapy researchers. This may be explained by the use of pill placebo, which controls for many nonspecific factors in medication trials. Theoretically, a research subject's expectation of therapeutic gain was equivalent between active medication and an identical-appearing pill placebo (Gaudiano and Herbert 2005).
However, the increasing need to study the relative efficacy of medications and psychotherap