Borderline personality disorder (BPD) is challenging to diagnose and treat. As yet, there are no drugs currently licensed for BPD treatment. In fact, guidance from England's National Institute for Health and Care Excellence recommends that pharmacologic therapy not be used for patients with BPD at all. This is potentially troubling, because those patients typically experience rapid and extreme changes in mood, poor social functioning and have high rates of suicidal behavior.
Borderline personality disorder (BPD) is challenging to diagnose and treat. As yet, there are no drugs currently licensed for BPD treatment. In fact, guidance from England’s National Institute for Health and Care Excellence recommends that pharmacologic therapy not be used for patients with BPD at all. This is potentially troubling, because those patients typically experience rapid and extreme changes in mood, poor social functioning and have high rates of suicidal behavior.
Some smaller-scale research has suggested that mood stabilizers may produce short-term reductions in symptoms of BPD, but few controlled, randomized clinical trials have been undertaken in this area. A new study announced in Trials will compare the effectiveness of the bipolar disorder and anti-seizure medication lamotrigine, which has been shown to be effective at preventing or delaying some depressive effects in patients with bipolar disorder, versus placebo in patients with BPD.
The lamotrigine and borderline personality disorder: Investigating Long-term Effectiveness trial (LABILE) is a multi-center, two-arm, parallel group, double-blind, placebo-controlled randomized trial with three-, six-, and 12-month follow-up assessment. It will be the first study to examine the long-term clinical effectiveness and cost-effectiveness of lamotrigine for people with BPD.
Lamotrigine is most effective for preventing the recurrent depressive episodes of bipolar disorder and may be effective at preventing or delaying mania or depressive cycles. It has been the subject of conflicting data on its effectiveness in treating acute bipolar depression. Lamotrigine prescribing information has a black box warning about life-threatening skin reactions and another for aseptic meningitis.
Patients with comorbid bipolar affective disorder or psychosis, those already taking a mood stabilizer, and women who are pregnant or contemplating becoming pregnant will be among those excluded from the study.
The primary outcome will be the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) — a widely used measure of symptoms and behavioral problems experienced by people with BPD. The secondary outcomes are depressive symptoms, deliberate self-harm, social functioning, health-related quality of life, resource use and costs, side effects of treatment, adverse events, and withdrawal of trial medication due to adverse effects.
One aspect of the LABILE study will examine the longer-term effects of offering treatment to patients with BPD. Previous studies typically have looked at outcomes only over eight to 12 weeks. Because BPD is a fluctuating condition, the study will also measure benefit at 12-, 26-, and 52-week follow-ups. Participants will be recruited from a broad range of secondary care mental health services. The study will also gather detailed information about resource use and other costs that will enable a high-quality economic evaluation of the impact of adding lamotrigine to usual care of people with BPD.
Recruitment is ongoing, with 218 participants (out of a goal of 252) recruited as of the end of May.