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Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00634062
First received: March 4, 2008
Last updated: March 11, 2008
Last verified: March 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Borderline Personality Disorder
 Drug: Lamotrigine
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

Resource links provided by NLM:

Drug Information available for: Lamotrigine
U.S. FDA Resources

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: December 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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
Other Name: Lamictal
Placebo Comparator: 2 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634062

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
GlaxoSmithKline
Investigators
Principal Investigator: D. Bradford Reich, M.D. Mclean Hospital
  More Information

Publications:

Responsible Party: D. Bradford Reich, M.D., McLean Hospital
ClinicalTrials.gov Identifier: NCT00634062     History of Changes
Other Study ID Numbers: 2004-P-002640
Study First Received: March 4, 2008
Last Updated: March 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
Affective Lability
Borderline Personality Disorder
Pharmacotherapy

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders
Lamotrigine
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013