Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634062
• Other study ID #: 2004-P-002640
• Status: Completed
• Phase: Phase 4
• First received: March 4, 2008
• Last updated: March 11, 2008
• Start date: December 2004
• Est. completion date: September 2007

Study information

• Verified date: March 2008
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in score of Affective Lability Scale		Baseline and then weekly for 12 weeks	No
Primary	Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder		Baseline and then weekly for 12 weeks	No
Secondary	Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder		Baseline and then weekly for 12 weeks	No