Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

Study Overview
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Brief Summary
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This study investigates the hypothesis that instability in mood in patients with borderline personality disorder will respond the mood stabilizing medication lamotrigine.

Detailed Description
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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.

Official Title
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Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Drug: Lamotrigine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Lamotrigine<br>* 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<br>* Other names: Lamictal;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder |  | Baseline and then weekly for 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Affective Lability, Borderline Personality Disorder, Pharmacotherapy