Borderline Personality Disorder
Conditions
Keywords
Affective Lability, Borderline Personality Disorder, Pharmacotherapy
Brief summary
This study investigates the hypothesis that instability in mood in patients with borderline personality disorder will respond the mood stabilizing medication lamotrigine.
Detailed description
Affective instability is one of the most prominent symptoms in borderline personality disorder. Currently there are no prospective studies of treatment of this symptom with mood stabilizing medications. This study examines the effectiveness of lamotrigine compared to placebo in reducing emotional instability of several types in borderline patients. The types of emotional instability studied involve anger, anxiety, depression, and elation. Subjects entering this 12 week study will be blind to whether they are receiving active medication or placebo. They will be asked to report levels of instability in their mood on a weekly basis. They will also be asked weekly to rate the intensity of other symptoms of borderline personality disorder symptoms, such as unstable relationships, self-harm, and impulsive behaviors.
Interventions
DRUGLamotrigine
Subject in active active drug group will receive lamotrigine tablets 12.5 per day for the first week of the study. Dose of lamotrigine can be increased to 25mg per day during the second week of the study and may be increased each week thereafter for the next 9 weeks by 25mg per day. Subjects in active treatment group will receive lamotrigine for total of 12 weeks
DRUGPlacebo
Subjects will receive 12.5mg of inert placebo per day during the first week of the study. Inert placebo can be increased to 25mg per day during the second week of the study and by 25mg per day each week for the next 9 weeks. Subjects can receive a total of 12 weeks of placebo.
Sponsors
GlaxoSmithKline
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Clinical Diagnosis of Borderline Personality Disorder with high levels of emotional instability
Exclusion criteria
* Clinical diagnosis of Bipolar Disorder * Clinical diagnosis of psychiatric disorder related to general medical condition * Clinical diagnosis of substance abuse disorder within the last 60 days * Clinical diagnosis of psychotic disorder * Previous treatment with lamotrigine * Pregnancy or nursing * Currently hospitalized * Active suicidal or homicidal ideation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in score of Affective Lability Scale | Baseline and then weekly for 12 weeks |
| Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder | Baseline and then weekly for 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder | Baseline and then weekly for 12 weeks |
Countries
United States
Outcome results
None listed