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

Phase 3

Withdrawn

• Conditions: Alcohol Dependence; Borderline Personality Disorder

• Registration Number: NCT00463775
• Lead Sponsor: Elizabeth Ralevski

Brief Summary

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

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).

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-18
• Study First Submitted QC: 2007-04-19
• Study First Posted: 2007-04-20
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-26
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
drinking - measured using the TLFB	12 weeks
craving - measured using the OCDS	12 weeks
aggression - measured using the STAE	12 weeks

Secondary Outcome Measures

Name	Time	Method
affect - measured using the Buss-Durkee Scale and Affective Intensity Scale	12 weeks
side effects - measured using the SAFTEE	12 weeks