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Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

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ClinicalTrials.gov Identifier: NCT00634062
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : March 12, 2008
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Mclean Hospital

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

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Drug: Lamotrigine Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
Study Start Date : December 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Lamotrigine

Arm Intervention/treatment
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.




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


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: D. Bradford Reich, M.D., McLean Hospital
ClinicalTrials.gov Identifier: NCT00634062     History of Changes
Other Study ID Numbers: 2004-P-002640
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: March 12, 2008
Last Verified: March 2008

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

Additional relevant MeSH terms:
Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders
Lamotrigine
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers