Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

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

Study Overview

• Status: Completed
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Drug: Lamotrigine; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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 Names: Lamictal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in score of Affective Lability Scale	Baseline and then weekly for 12 weeks
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder	Baseline and then weekly for 12 weeks

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: D. Bradford Reich, M.D., McLean Hospital

Publications and helpful links

General Publications

• Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
• 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. doi: 10.1017/s1092852900020927.
• 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. doi: 10.1177/0269881105051540.
• 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. doi: 10.1016/s0165-0327(99)00007-5.

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: March 4, 2008
• First Submitted That Met QC Criteria: March 11, 2008
• First Posted (Estimate): March 12, 2008

Study Record Updates

• Last Update Posted (Estimate): March 12, 2008
• Last Update Submitted That Met QC Criteria: March 11, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Borderline Personality Disorder; Pharmacotherapy; Affective Lability
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Disease; Borderline Personality Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anticonvulsants; Sodium Channel Blockers; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Lamotrigine
• Other Study ID Numbers: 2004-P-002640