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., …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