Lamotrigine And Borderline personality disorder: Investigating Long term Effectiveness

The clinical and cost effectiveness of lamotrigine for people with borderline personality disorder: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90916365

Enrollment

252

Registered

2012-08-01

Start date

2012-11-01

Completion date

Unknown

Last updated

2019-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline personality disorder Mental and Behavioural Disorders Emotionally unstable personality disorder

Interventions

1. Lamotrigine (oral, once daily, up to 200mg daily - unless the study participants is taking the combined oral contraceptive pill in which case the maximum daily dose will be 400mg daily)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 and above 2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for borderline personality disorder 3. Competent and willing to provide written, informed consent

Exclusion criteria

Exclusion criteria: 1. Currently fulfilling criteria for bipolar affective disorder (type I & II), or psychotic disorder (schizophrenia, schizoaffective disorder, or mood disorder with psychotic features) 2. Already being prescribed a mood stabiliser(s) 3. Daily use of alcohol or illicit drugs during the previous three months 4. Known medical history of liver or kidney impairment 5. Cognitive or language difficulties that would preclude subjects providing informed consent or compromise participation in study procedures 6. Any woman who is pregnant or planning a pregnancy, and any woman of child bearing potential unless using adequate contraception

Design outcomes

Primary

Measure	Time frame
Symptoms of BPD measured at 52 weeks using the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)	—

Secondary

Measure	Time frame
1. Total score on the Zanarini Rating Scale for Borderline Personality Disorder at 12 and 24 weeks 2. Depressive symptoms measured using the Beck Depression Inventory at 12, 24 and 52 weeks 3. The incidence and severity of suicidal behaviour using the Acts of Deliberate Self-Harm Inventory at12, 24 and 52 weeks 4. Social functioning assessed using the Social Functioning Questionnaire at 12, 24 and 52 weeks 5. Health-related quality of life, assessed using the Euro-QOL-5D (EQ-5D) at 12, 24 and 52 weeks 6. Side effects of trial medications using a proforma specifically designed for the study will be assessed at 12, 24, and 52 weeks 7. Resource use assessed using a modified version of the Adult Service Use Schedule at 12, 24 and 52 weeks 8. Body weight measured at 24 and 52 weeks	—

Measure

Time frame

1. Total score on the Zanarini Rating Scale for Borderline Personality Disorder at 12 and 24 weeks 2. Depressive symptoms measured using the Beck Depression Inventory at 12, 24 and 52 weeks 3. The incidence and severity of suicidal behaviour using the Acts of Deliberate Self-Harm Inventory at12, 24 and 52 weeks 4. Social functioning assessed using the Social Functioning Questionnaire at 12, 24 and 52 weeks 5. Health-related quality of life, assessed using the Euro-QOL-5D (EQ-5D) at 12, 24 and 52 weeks 6. Side effects of trial medications using a proforma specifically designed for the study will be assessed at 12, 24, and 52 weeks 7. Resource use assessed using a modified version of the Adult Service Use Schedule at 12, 24 and 52 weeks 8. Body weight measured at 24 and 52 weeks

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026