The clinical effectiveness and cost effectiveness of lamotrigine for people with borderline personality disorder: a randomized, placebo-controlled trial

Crawford, Mike J.; Sanatinia, Rahil; Barrett, Barbara; Cunningham, Gillian; Dale, Oliver; Ganguli, Poushali; Lawrence-Smith, Geoff; Leeson, Verity; Lemonsky, Fenella; Lykomitrou, Georgia; Montgomery, Alan A.; Morriss, Richard K.; Munjiza, Jasna; Paton, Carol; Skorodzien, Iwona; Singh, Vineet; Tan, Wei; Tyrer, Peter; Reilly, Joseph G.

Abstract

Objectives: To examine whether lamotrigine is a clinically effective and cost-effective treatment for people with borderline personality disorder.

Method: Multicentre, double-blind, placebo-controlled randomized trial. Between July 2013 to November 2016, we recruited 276 people aged 18 or over, who met diagnostic criteria for borderline personality disorder. We excluded those with co-existing bipolar affective disorder or psychosis, those already taking a mood stabiliser, and women at risk of pregnancy. We randomly allocated participants on a 1:1 ratio to up to 400mg of lamotrigine per day or an inert placebo using a remote web-based randomization service. The primary outcome was total score on the Zanarini Rating scale for Borderline Personality Disorder (ZAN-BPD) at 52 weeks. Secondary outcomes 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: 195 (70.6%) participants were followed up at 52 weeks, at which point 49 (36%) of those prescribed lamotrigine and 58 (42%) of those prescribed placebo were taking it. Mean total ZAN-BPD score was 11.3 (SD = 6.6) among those randomized to lamotrigine and 11.5 (SD = 7.7) among those randomized to placebo (adjusted difference in means = 0.1, 95% C.I = -1.8 to 2.0, p=0.91). There was no evidence of any differences in secondary outcomes. Costs of direct care for those prescribed lamotrigine were similar to those prescribed placebo.

Conclusions: Treating people with borderline personality disorder with lamotrigine is not a clinically effective or cost-effective use of resources.

Citation

Crawford, M. J., Sanatinia, R., Barrett, B., Cunningham, G., Dale, O., Ganguli, P., Lawrence-Smith, G., Leeson, V., Lemonsky, F., Lykomitrou, G., Montgomery, A. A., Morriss, R. K., Munjiza, J., Paton, C., Skorodzien, I., Singh, V., Tan, W., Tyrer, P., & Reilly, J. G. (2018). The clinical effectiveness and cost effectiveness of lamotrigine for people with borderline personality disorder: a randomized, placebo-controlled trial. American Journal of Psychiatry, 175(8), 756-764. https://doi.org/10.1176/appi.ajp.2018.17091006

• Journal Article Type: Article
• Acceptance Date: Feb 20, 2017
• Online Publication Date: Apr 6, 2018
• Publication Date: Aug 1, 2018
• Deposit Date: Jan 4, 2018
• Publicly Available Date: Apr 7, 2019
• Journal: American Journal of Psychiatry
• Print ISSN: 0002-953X
• Electronic ISSN: 1535-7228
• Publisher: Psychiatry Online
• Peer Reviewed: Peer Reviewed
• Volume: 175
• Issue: 8
• Pages: 756-764
• DOI: https://doi.org/10.1176/appi.ajp.2018.17091006
• Public URL: https://nottingham-repository.worktribe.com/output/923999
• Publisher URL: https://ajp.psychiatryonline.org/doi/abs/10.1176/appi.ajp.2018.17091006
• Additional Information: The official published article is available online at https://ajp.psychiatryonline.org/doi/abs/10.1176/appi.ajp.2018.17091006
• Contract Date: Jan 4, 2018