amotrigine And Borderline personality disorder: Investigating Long term Effectiveness

Not Applicable

Completed

• Conditions: Borderline personality disorder; Mental and Behavioural Disorders; Emotionally unstable personality disorder

• Registration Number: ISRCTN90916365
• Lead Sponsor: Imperial College London (UK)

Brief Summary

1. 2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26187496 2. 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29651981 3. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29621901 (added 11/07/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-01
• Study Completion: 2017-01-31
• Last Update Posted: 29 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 276

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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