Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder - Full Text View

Sponsor:	Mclean Hospital
Collaborator:	GlaxoSmithKline
Information provided by:	Mclean Hospital
ClinicalTrials.gov Identifier:	NCT00634062

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

Resource links provided by NLM:

MedlinePlus related topics: Personality Disorders

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
1: Active Comparator	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
2: Placebo Comparator	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:

Weinstein W, Jamison KL. Retrospective case review of lamotrigine use for affective instability of borderline personality disorder. CNS Spectr. 2007 Mar;12(3):207-10.

Tritt K, Nickel C, Lahmann C, Leiberich PK, Rother WK, Loew TH, Nickel MK. Lamotrigine treatment of aggression in female borderline-patients: a randomized, double-blind, placebo-controlled study. J Psychopharmacol. 2005 May;19(3):287-91.

Pinto OC, Akiskal HS. Lamotrigine as a promising approach to borderline personality: an open case series without concurrent DSM-IV major mood disorder. J Affect Disord. 1998 Dec;51(3):333-43.

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

Keywords provided by Mclean Hospital:

Affective Lability
Borderline Personality Disorder
Pharmacotherapy

Additional relevant MeSH terms:

Disease
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Cardiovascular Agents
Borderline Personality Disorder
Pharmacologic Actions
Membrane Transport Modulators

Pathologic Processes
Mental Disorders
Therapeutic Uses
Lamotrigine
Central Nervous System Agents
Anticonvulsants
Personality Disorders

ClinicalTrials.gov processed this record on November 09, 2009