Study of Lamotrigine Treatment of Affective Instability in Borderline Personality Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Borderline Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Lamotrigine

Intervention Type DRUG

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

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Lamictal

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No