Condition category
Mental and Behavioural Disorders
Date applied
12/06/2012
Date assigned
01/08/2012
Last edited
07/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
People with borderline personality disorder have poor mental health and may experience sudden and distressing changes in mood. No medication is currently licensed to help people with borderline personality disorder and treatment options for patients are therefore limited. Lamotrigine is a mood stabiliser which has been successfully used to help people with mood disorders. In this study we will test whether adding lamotrigine to usual treatment for people with borderline personality disorder improves mental health and is a cost-effective use of resources.

Who can participate?
People aged 18 or over who are in contact with mental health services in England and have a diagnosis of borderline personality disorder.

What does the study involve?
All those who take part in the study will receive a full assessment of their mental health, social functioning and use of healthcare services before their entry into the study. All those who take part in the study will have three follow-up assessments, 12, 24 and 52 weeks after their entry into the study. Half the study participants will be prescribed lamotrigine and the other half will be prescribed a placebo (dummy) which is identical in appearance to the lamotigine but does not contain any active drug. All people in the study will continue to have access to services including other drug treatments.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part, however study participants will be helping make sure that in the future people with borderline personality disorder receive better treatment. There are no risks from taking the part other than, among people who receive lamotrigine, who may experience side effects from taking this medication.

Where is the study run from?
The study is run from the Centre for Mental Health at Imperial College London in collaboration with University of Nottingham, Tees, Esk & Wear Valleys NHS Foundation Trust, Kings College London, Central and North West London NHS Foundation Trust, Oxleas NHS Foundation Trust, and Nottinghamshire Healthcare NHS Trust

When is the study starting and how long is it expected to run for?
We will start to recruit study participants in early 2013. Recruitment is due to end in 2015 and the results of the study are due to be published at the end of 2017. Each study participant will be followed-up for at least one year, but the study may be extended for a further period to examine the longer-term impact of the use of lamotrigine on mental health of people with borderline personality disorder.

Who is funding the study?
National Institute for Health Research (UK): Health Technology Assessment programme

Who is the main contact?
Prof Mike Crawford
m.crawford@imperial.ac.uk

Trial website

www.labile.org

Contact information

Type

Scientific

Primary contact

Prof Mike Crawford

ORCID ID

Contact details

Centre for Mental Health
Imperial College London
Claybrook Centre
37
Claybrook Road
London
W6 8LN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 10/103/01

Study information

Scientific title

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

Acronym

LABILE

Study hypothesis

The main aims of the study are:
1. To test whether adding lamotrigine to usual care for adults with borderline personality disorder (BPD) improves mental health over a 52 week period, in comparison to a placebo control.
2. To examine whether the addition of lamotrigine to usual care for adults with BPD improves social functioning and quality of life, reduces the incidence of suicidal behaviour, and lowers the amount of antipsychotic and other psychotropic medication that people are prescribed, in comparison to a placebo control.
3. To compare the incidence of side effects among those prescribed lamotrigine in addition to usual care for adults with BPD, in comparison to a placebo control.
4. To examine the cost, cost-utility and cost-effectiveness of adding lamotrigine to usual care for adults with BPD, in comparison to a placebo control.

Our primary hypothesis is that the addition of lamotrigine to usual treatment of people with borderline personality disorder who are in contact with mental health services will reduce symptoms of their disorder measured at 12 months using the Zanarini Rating Scale for Borderline Personality Disorder.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/1010301
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0019/81721/PRO-10-103-01.pdf

Ethics approval

Not provided at time of registration

Study design

Multi-centre two-arm parallel-group double-blind placebo-controlled randomised trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Borderline personality disorder

Intervention

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).

Placebo (oral, once daily).

Follow-up assessment at 12, 24 and 52 weeks.

Intervention type

Drug

Phase

Not Applicable

Drug names

Lamotrigine

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/11/2012

Overall trial end date

31/01/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

252 (126 in the active and 126 in the control arm of the trial)

Participant 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

Recruitment start date

01/11/2012

Recruitment end date

31/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College London
London
W6 8LN
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

5th Floor
Lab Block
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/07/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26187496

Publication citations

Additional files

Editorial Notes

07/10/2016: the overall trial end date was changed from 30/10/2015 to 31/01/2017.