Defining Response in Clinical Trials for Obsessive-Compulsive Disorder

OBJECTIVE: Many studies of the treatment of obsessive-compulsive disorder (OCD) have used percent reduction cutoffs on the Yale-Brown Obsessive Compulsive Scale (YBOCS) to classify patients as treatment responders. However, reduction criteria have varied from 20% to 50%, with studies of cognitive-behavioral therapy (CBT) using a more stringent criterion than studies of pharmacotherapy. The aim of this retrospective investigation was to determine optimal YBOCS reduction criteria for classifying patients as responders. METHOD: Data from 87 adult clinic and research outpatients meeting DSM-IV-TR criteria for OCD according to structured interview were examined, comparing the percent YBOCS reduction from pretreatment to posttreatment with 2 "gold standard" criteria from the Clinical Global Impressions (CGI) scale: much or very much improved and mild illness or better. Signal detection analyses were used to determine the sensitivity, specificity, predictive value of a positive test, predictive value of a negative test, and efficiency of various YBOCS reduction cutoffs. RESULTS: A YBOCS reduction cutoff of 30% was optimal for predicting improvement on the CGI. The 20% cutoff used by many pharmacologic studies resulted in a high number of false positives, whereas the 50% cutoff used by most CBT studies resulted in a high number of false negatives. For predicting mild illness or better at posttreatment, a YBOCS reduction cutoff of 40% to 50% was optimal. CONCLUSIONS: A YBOCS reduction criterion of 30% appears to be optimal for determining clinical improvement, whereas a 40% to 50% reduction criterion is appropriate for predicting mild illness at posttreatment. Future studies should employ a standard definition of treatment response in order to facilitate cross-study comparisons.