Clinical trial NCT00634062: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Borderline Personality Disorder
Keywords: Affective Lability
Borderline Personality Disorder
Pharmacotherapy
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2008-03-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in score of Affective Lability Scale
timeFrame: Baseline and then weekly for 12 weeks
measure: Changes in the score of the Affective Lability Item of the Zanarini Rating Scale for Borderline Personality Disorder
timeFrame: Baseline and then weekly for 12 weeks
Secondary outcomes:
measure: Scores of individual items on the Zanarini Rating Scale for Borderline Personality Disorder
timeFrame: Baseline and then weekly for 12 weeks
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: D. Bradford Reich, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.