Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder
Study Details
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 |
|---|---|---|
|
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
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 Names:
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| 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
- 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
- Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder [Baseline and then weekly for 12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Clinical Diagnosis of Borderline Personality Disorder with high levels of emotional instability
Exclusion Criteria:
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Clinical diagnosis of Bipolar Disorder
-
Clinical diagnosis of psychiatric disorder related to general medical condition
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Clinical diagnosis of substance abuse disorder within the last 60 days
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Clinical diagnosis of psychotic disorder
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Previous treatment with lamotrigine
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Pregnancy or nursing
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Currently hospitalized
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Active suicidal or homicidal ideation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | McLean Hospital | Belmont | Massachusetts | United States | 02478 |
Sponsors and Collaborators
- Mclean Hospital
- GlaxoSmithKline
Investigators
- Principal Investigator: D. Bradford Reich, M.D., Mclean Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 2004-P-002640