Who's left? Symptoms of schizophrenia that predict clinical trial dropout

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Abstract

A significant proportion of subjects drop out of medium to long-term clinical studies prior to trial completion. This may bias reported study outcomes and reduce the statistical power of analyses. There is therefore a need for researchers to better understand the characteristics of dropout populations to increase completion rates. Data from a set of participants recruited as part of a 24-week placebo-controlled trial were used to determine the relationship between the five Lindenmayer factors of positive, negative, cognitive, anxiety/depression and excitement symptoms and dropout at trial completion. Results indicated that the rate of trial dropout was significantly predicted by scores on the negative Lindenmayer factor (X2(6, N = 126) = 15.60, p < .05). By trial completion, participants with ‘high’ negative Lindenmayer scores dropped out at a rate of 64%, whereas ‘medium’ and ‘low’ groups dropped out at 43% and 30%, respectively. No other relationship between symptom severity scores and dropout across the remaining Lindenmayer factors was found. These findings reflect important considerations for the future design of clinical trials involving people with schizophrenia and may also provide clues into treatment compliance issues more generally. Copyright © 2011 John Wiley & Sons, Ltd.

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