Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

Phase 4

Completed

• Conditions: Borderline Personality Disorder
• Interventions: Drug: Lamotrigine; Drug: Placebo

• Registration Number: NCT00634062
• Lead Sponsor: Mclean Hospital

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.

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2008-03
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-11
• Last Update Submitted: 2008-03-11
• Study First Posted: 2008-03-12
• Last Update Posted: 2008-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lamotrigine	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder	Baseline and then weekly for 12 weeks

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States