Excluding the typical patient: thirty years of pharmacotherapy efficacy trials for obsessive-compulsive disorder.

BACKGROUND: Over the past 30 years, clinical trials have resulted in several successful pharmacotherapies for obsessive-compulsive disorder (OCD), yet patients in clinical settings often report inadequate response. This study compares clinical characteristics of treatment-seeking OCD patients to the inclusion/exclusion criteria used in pharmacotherapy trials. METHODS: The sample consisted of 325 community members with a DSM-IV diagnosis of OCD who underwent systematic interviews with clinicians knowledgeable in the diagnosis and treatment of OCD. We compiled pharmacotherapy studies for OCD published between 1980 and 2010 using Medline, PubMed, and library resources, and estimated the proportion of patients in each decade satisfying the most common inclusion/exclusion criteria. RESULTS: We included 39 clinical trials and found 72% of the 325 patients would have been excluded from trials conducted between 1980 and 2010. Exclusion was projected as dramatically lower for trials conducted between 1980 and 1989 (19.7%) compared with 74.8% for trials conducted between 1990 and 1999 and 76.9% for trials between 2000 and 2010. CONCLUSIONS: The majority of treatment-seeking individuals with OCD would not qualify for OCD treatment studies due to comorbid psychiatric disorders, and failure to meet OCD severity threshold criteria. This illustrates the need to include a more community-representative sample of OCD patients in clinical trials examining pharmacotherapy efficacy.