Generalizability of Pharmacological and Psychotherapy Clinical Trial Results for Borderline Personality Disorder to Community Samples: Results From the 2004-2005 National epidemiologic Survey on Alcohol and Related Conditions (NESARC)

Lopez, S. 1, 2 , Zorrilla, I. 1, 2 , Gonzalez-Pinto, A. M. 1, 2 & Lopez, P. 1, 2

1 Hospital Universitario de Alava, sede Santiago
2 cibersam group 10

Background: The present study sought to quantify the generalizability of clinical trial results in individuals with a DSM-IV diagnosis of borderline personality disorder (BPD) to a representative community sample.

Method: Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a large nationally representative sample from the United States population. We applied a standard set of exclusion criteria representative of pharmacological and psychotherapy clinical trials to adults with a DSM-IV diagnosis of BPD (n = 2,231). Our aim was to assess how many participants with BPD would fulfil eligibility criteria.

Results: We found that more than seven out of ten respondents in a pharmacological efficacy trial and more than five out of ten in a psychotherapy efficacy trial would have been excluded by at least one criterion. Having a current history of substance use disorder and a lifetime history of bipolar disorder explained a large proportion of ineligibility.

Discussion: Clinical trials should consider the impact of exclusion criteria on the generalizability of their results. As required by CONSORT guidelines, reporting exclusion rate estimate and reasons of eligibility should be mandatory in clinical trials. As treatment trials of BPD move from efficacy to effectiveness to better inform clinical practice, the eligibility rate must be increased by imposing less stringent eligibility criteria to allow for more generalizable results.