Methodological considerations for treatment trials for persons with borderline personality disorder

BACKGROUND: The National Institute of Mental Health convened an international group of experts to examine the conduct of treatment trials for persons with borderline personality disorder (BPD). The rapid growth of treatment research had led to the recognition that investigators face unique methodological issues with these challenging patients. METHODS: Conference members reviewed critical aspects of psychotherapy and pharmacotherapy trial design for patients with BPD. RESULTS: This article summarizes discussions held on March 17-18, 2005. CONCLUSION: This paper addresses the most pressing issues in sample selection and trial design pertaining to BPD; issues that have bedeviled both investigators submitting applications and reviewers trying to assess the merit of these grants. By disseminating this work, conference members hope to make this process more consistent and productive for all concerned.