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Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
This study has been completed.
Study NCT00634062   Information provided by Mclean Hospital
First Received: March 4, 2008   Last Updated: March 11, 2008   History of Changes

March 4, 2008
March 11, 2008
December 2004
September 2007   (final data collection date for primary outcome measure)
  • Changes in score of Affective Lability Scale [ Time Frame: Baseline and then weekly for 12 weeks ] [ Designated as 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00634062 on ClinicalTrials.gov Archive Site
Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder [ Time Frame: Baseline and then weekly for 12 weeks ] [ Designated as safety issue: No ]
Same as current
 
Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
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.

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.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Borderline Personality Disorder
  • Drug: Lamotrigine
  • Drug: Placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
28
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00634062
D. Bradford Reich, M.D., McLean Hospital
2004-P-002640
Mclean Hospital
GlaxoSmithKline
Principal Investigator: D. Bradford Reich, M.D. Mclean Hospital
Mclean Hospital
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP