Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
Primary Purpose
Borderline Personality Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lamotrigine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Affective Lability, Borderline Personality Disorder, Pharmacotherapy
Eligibility 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
Sites / Locations
- McLean Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Changes in score of Affective Lability Scale
Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder
Secondary Outcome Measures
Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder
Full Information
NCT ID
NCT00634062
First Posted
March 4, 2008
Last Updated
March 11, 2008
Sponsor
Mclean Hospital
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00634062
Brief Title
Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
Official Title
Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mclean Hospital
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Affective Lability, Borderline Personality Disorder, Pharmacotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lamotrigine
Other Intervention Name(s)
Lamictal
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Changes in score of Affective Lability Scale
Time Frame
Baseline and then weekly for 12 weeks
Title
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 Measure Information:
Title
Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder
Time Frame
Baseline and then weekly for 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. Bradford Reich, M.D.
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17329981
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. doi: 10.1017/s1092852900020927.
Results Reference
background
PubMed Identifier
15888514
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. doi: 10.1177/0269881105051540.
Results Reference
background
PubMed Identifier
10333987
Citation
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.
Results Reference
background
PubMed Identifier
36375174
Citation
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.
Results Reference
derived
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Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
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