Methodological considerations for treatment trials for persons with borderline personality disorder

Mary C. Zanarini, Harvard Medical School
Barbara Stanley, Columbia University College of Physicians and Surgeons
Donald W. Black, University of Iowa Roy J. and Lucille A. Carver College of Medicine
John C. Markowitz, Columbia University College of Physicians and Surgeons
Marianne Goodman, Mount Sinai School of Medicine
Paul Pilkonis, University of Pittsburgh
Thomas R. Lynch, University of Exeter
Kenneth Levy, The Pennsylvania State University
Peter Fonagy, University College London
Martin Bohus, Central Institute of Mental Health Mannheim, Germany
Joan Farrell, Indiana University School of Medicine
Charles A. Sanislow, Wesleyan University

Abstract

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.