Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence

Study Overview
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Brief Summary
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The objective of the present study is to evaluate the efficacy of topiramate (250mg/day) versus placebo in decreasing aggression and reducing alcohol consumption in patients with borderline personality disorder (BPD) and alcohol dependence (AD).

Detailed Description
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Background: Borderline personality disorder (BPD) affects about 2% of the American adult population. It is a very serious psychiatric disorder that places heavy demands on mental health resources. Behavior dysregulation (impulsivity, self-injurious acts, drinking or aggressive behavior) is considered one of the main features of BPD and is associated with significant clinical morbidity. Alcohol abuse is common among patients with BPD, and the co-morbid rates of alcoholism in BPD patients are estimated to be 30%. It has been hypothesized that alcohol misuse may be a manifestation of BPD's behavioral dysregulation. Also, BPD and alcohol dependence (AD) share a common underlying neurobiology. The co-occurrence of these disorders has been associated with increased rates of alcohol relapse, impulsive behaviors, greater resistance to treatment, and suicidal behavior. Effective treatment for patients with BPD and AD would result in markedly reduced health care costs and a substantial reduction in human distress and suffering. Despite dramatic advances in the treatment of BPD, to date, no single medication or types of medications have been uniquely identified as effective in treating BPD. Studies treating patients with co-morbid BPD and AD are expressly lacking. Research Design and Methodology: This is an 8-week double-blind outpatient clinical trial of oral topiramate (250mg) vs placebo in individuals with BPD and AD. The study will be conducted at the West Haven, CT VA. Thirty men and women with a current diagnosis of BPD and AD will be enrolled. The State-Trait Anger Expression Inventory (STAEI) will be used to assess 5 aspects of aggression: state anger, trait anger, anger expressed inwardly, anger expressed outwardly, and anger control before and during treatment (weeks 0-8). The Timeline Follow-Back (TLFB) method will be used to document the degree of daily alcohol consumption before and during treatment (90 days before treatment, and weeks 0 - 8). Emergent side effects will be assessed using the modified version of the Systematic Assessment for Treatment Emergent Events (SAFTEE).

Official Title
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Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence

Conditions
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Alcohol Dependence, Borderline Personality Disorder

Intervention / Treatment
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* Drug: Topiramate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of AD Diagnosis of BPD Exclusion Criteria: Serious or unstable medical condition Opiate dependence Major Axis I disorder (bipolar disorder, schizophrenia) Taking mood stabilizers and antipsychotic medications LFT abnormalities that do not exceed 3 times normal values

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topiramate|SSRI plus topiramate SSRI plus placebo|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| drinking - measured using the TLFB |  | 12 weeks | 
| craving - measured using the OCDS |  | 12 weeks | 
| aggression - measured using the STAE |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| affect - measured using the Buss-Durkee Scale and Affective Intensity Scale |  | 12 weeks | 
| side effects - measured using the SAFTEE |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment, Topiramate, Alcohol Dependence, Borderline Personality Disorder