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Completed

NCT Number: NCT00634062

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.

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Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lamotrigine

Drug

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

Other names: Lamictal

Placebo

Drug

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.

Primary outcomes

  1. Changes in score of Affective Lability Scale

    Time frame: Baseline and then weekly for 12 weeks

  2. 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

Secondary outcomes

  1. Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder

    Time frame: Baseline and then weekly for 12 weeks

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Mar 12, 2008
Registry last updated
Mar 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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