LABILE

• Research type

  Research Study

• Full title

  Lamotrigine And Borderline Personality Disorder: Investigating Long-Term Effectiveness

• IRAS ID

  107719

• Contact name

  Mike Crawford

• Sponsor organisation

  Imperial College London and Imperial College Healthcare NHS Trust

• Eudract number

  2012-003136-23

• ISRCTN Number

  ISRCTN90916365

• Research summary

  A multi-centre, two-arm, parallel group, double-blind, placebo-controlled, randomised trial, to be conducted in secondary care mental health services, at five UK centres: East Midlands, North, South East, and West London, and Teeside. The trial will integrate a clinical and economic evaluation and examine the impact of adding lamotrigine to treatment as usual for adults with Borderline Personality Disorder over a 54 week period. All those taking part in the study will continue to receive treatment as usual from primary and secondary care services. In addition, those randomised to active treatment will be prescribed up to 200mg of generic lamotrigine titrated over a six week period. In keeping with clinical recommendations, the regime for titrating the dose of lamotrigine will be modified for women taking the combined oral contraceptive pill. Those randomised to the control treatment will receive treatment as usual plus an inert placebo. 252 patients shall be recruited over a 24 month period, and each participant shall be assessed at baseline, 12, 24, and 52 weeks. The primary outcome of the trial is symptoms of Borderline Personality Disorder measured at 52 weeks using the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD). The ZAN-BPD is a widely used measure of symptoms and behavioral problems experienced by people with borderline personality disorder. It includes measures of anger, impulsivity and affective instability. Therapeutic improvement will also be assessed in terms of broader, clinically relevant outcome measures of social functioning as well as overall health status and utility. Side effects will be systematically assessed. The costs and outcomes to allow for a cost effectiveness acceptability and net benefit analysis will also be measured.

• REC name

  London - Central Research Ethics Committee

• REC reference

  12/LO/1514

• Date of REC Opinion

  5 Oct 2012

• REC opinion

  Favourable Opinion