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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2007

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.

Intervention(s) in this Clinical Trial

• Drug: Lamotrigine
  • 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
• Drug: Placebo
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2

Primary Measures

• Changes in score of Affective Lability Scale
  • Time Frame: Baseline and then weekly for 12 weeks
    Safety Issue?: No
• Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder
  • Time Frame: Baseline and then weekly for 12 weeks
    Safety Issue?: No

Secondary Measures

• Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder
  • Time Frame: Baseline and then weekly for 12 weeks
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mclean Hospital

Overall Clinical Trial Officials and Contacts

D. Bradford Reich, M.D. Principal Investigator Mclean Hospital  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00634062

Study ID Number: 2004-P-002640

ClinicalTrials.gov Identifier: NCT00634062

Health Authority: United States: Institutional Review Board