Clinical Trial: Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Mclean Hospital

Current Primary Outcome:

  • Changes in score of Affective Lability Scale [ Time Frame: 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 [ Time Frame: Baseline and then weekly for 12 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder [ Time Frame: Baseline and then weekly for 12 weeks ]

Original Secondary Outcome: Same as current

Information By: Mclean Hospital

Dates:
Date Received: March 4, 2008
Date Started: December 2004
Date Completion:
Last Updated: March 11, 2008
Last Verified: March 2008