This was a multicenter, double-blind, placebo-controlled randomized trial. Between July 2013 and November 2016, the authors recruited 276 people age 18 or over who met diagnostic criteria for borderline personality disorder. Individuals with coexisting bipolar affective disorder or psychosis, those already taking a mood stabilizer, and women at risk of pregnancy were excluded. A web-based randomization service was used to allocate participants randomly in a 1:1 ratio to receive either an inert placebo or up to 400 mg/day of lamotrigine. The primary outcome measure was score on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) at 52 weeks. Secondary outcome measures included depressive symptoms, deliberate self-harm, social functioning, health-related quality of life, resource use and costs, side effects of treatment, and adverse events.

Results:

A total of 195 (70.6%) participants were followed up at 52 weeks, at which point 49 (36%) of those in the lamotrigine group and 58 (42%) of those in the placebo group were taking study medication. The mean ZAN-BPD score was 11.3 (SD=6.6) among those in the lamotrigine group and 11.5 (SD=7.7) among those in the placebo group (adjusted difference in means=0.1, 95% CI=−1.8, 2.0). There was no evidence of any differences in secondary outcomes. Costs of direct care were similar in the two groups.

Conclusions:

The results suggest that treating people with borderline personality disorder with lamotrigine is not a clinically effective or cost-effective use of resources.

Editor Spotlight

Volume 175
Issue 8

August 01, 2018
Pages 756-764

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The authors thank all those who took part in the study and clinical staff at Central and North West London NHS Foundation Trust, Derbyshire Healthcare NHS Foundation Trust, Nottinghamshire Healthcare NHS Foundation Trust, Oxleas NHS Foundation Trust, Tees, Esk and Weir Valley NHS Foundation Trust, and West London NHS Mental Health Trust for their help with completing the study, especially Ms. Lauren Bryant, Ms. Adele Mason, Mr. John Lawton, Dr. Ben Lucas, Dr. Paul Mallett, Dr. Tom McLaren, Dr. Ayodeji Morah, Dr. Bal Powar, Dr. Paola Rossin, Dr. Zahir Shah, and Ms. Danielle Wilson. The authors also thank the Clinical Research Network for publicizing the study and supporting the recruitment and follow-up of study participants. They would especially like to thank Pat Daly, Anthony Davis, Tara Harvey, Bianca Hinds-Walters, Natalie Marking, Antoinette McNulty, Lorraine O’Connell, Sandra Simpson, Lisa Thompson, and Audrey Williamson for supporting study recruitment and helping with participant follow-up. The authors also thank members of the trial coordinating team at Imperial College London, including Claudia Adele, Amy Claringbold, Zoe Cotton, Kavi Gakhal, Ana Arbeloa del Moral, Lesley O’Connell, and Dilveer Sually, for overseeing the administration of the trial. The authors are grateful to all members of the Trial Steering Committee (Maxine Patel [chair, 2013–2015], Paul Moran [chair, 2015–2016], Delia Bishara, Oliver Dale, Sandra O’Sullivan, and Jenny Trite) and the Data Monitoring and Ethical Committees (Nicol Ferrier [Chair], Tony Johnson, and Steve Pearce) for their support and guidance. The authors are grateful to Sally Strange for advising on study logistics and Jennie Parker for helping in the interpretation and communication of study findings.

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History

Received 15 September 2017

Revised 27 December 2017

Accepted 20 February 2018

Published online 6 April 2018

Published in print 1 August 2018

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The Clinical Effectiveness and Cost-Effectiveness of Lamotrigine in Borderline Personality Disorder: A Randomized Placebo-Controlled Trial

Abstract

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