Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Borderline Personality Disorder

Treatments: Drug: Lamotrigine; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00634062

2004-P-002640

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Lamotrigine

2

Placebo Comparator group

Treatment:

Drug: Placebo