A 52-week clinical trial will test whether the mood-stabilising drug lamotrigine can improve mental health in people with borderline personality disorder (BPD), a condition for which no drugs are currently licensed. This matters because people with BPD experience severe emotional instability, recurrent suicidal behaviour, and poor interpersonal functioning. Small-scale studies have suggested that mood stabilisers like lamotrigine might help, but the evidence is not strong enough to change clinical practice. Without a large, rigorous trial, doctors have no clear guidance on whether to prescribe these drugs off-label. If lamotrigine proves effective, the impact could be direct and practical: a safe, affordable medication added to usual care could reduce symptoms, lower the need for antipsychotics and other psychotropic drugs, and decrease suicidal behaviour. The trial also measures social functioning, quality of life, side effects, and cost-effectiveness, so the results would give the NHS a clear picture of whether the drug is worth using in routine care. If it does not work, the trial will spare patients unnecessary medication and save healthcare resources.
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Background: People with Borderline Personality Disorder (BPD) experience affective instability, recurrent suicidal behaviour and poor interpersonal functioning. No drugs are currently licensed for the treatment of BPD but small-scale studies of mood stabilisers, such as lamotrigine, suggest that they may have a role in improving the mental health of people with this disorder. Aims: To examine the clinical and cost-effectiveness of adding lamotrigine to usual care for people with borderline personality disorder. To achieve this aim we will: i. Test whether adding lamotrigine improves mental health over a 52 week period, in comparison to a placebo control. ii. Examine whether the addition of lamotrigine to usual care for adults with BPD improves social functioning and health-related quality of life, reduces the incidence of suicidal behaviour, and lowers the amount of antipsychotic and other psychotropic medication that people are prescribed. iii. Compare the incidence of side effects among those prescribed lamotrigine in addition to usual care, in comparison to a placebo control. iv. Examine the cost, cost-utility and cost-effectiveness of adding lamotrigine to usual, in comparison to a placebo control. Methods: A multi-centre, two-arm, parallel group, double-blind, placebo-controlled, randomised trial. Equal numbers of eligible patients will be randomised to receive lamotrigine or placebo in addition to their usual care. We aim to recruit 252 people aged 18 or over and follow up 85% one year later. Our primary outcome measure is symptoms of borderline personality disorder measured at 52 weeks. Our secondary outcomes are depression, incidence and severity of suicidal behaviour, social functioning, health-related quality of life assessed, side effects of study treatments and resource use. Primary statistical analysis will be performed on an intention to treat basis.
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