Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

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

Study Description

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 Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

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: D. Bradford Reich, M.D., McLean Hospital
• ClinicalTrials.gov Identifier: NCT00634062
• Other Study ID Numbers: 2004-P-002640
• First Posted: March 12, 2008
• 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:

Lamotrigine; Disease; Personality Disorders; Borderline Personality Disorder; Pathologic Processes; Mental Disorders; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Sodium Channel Blockers