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

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2010

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).

Intervention(s) in this Clinical Trial

• Drug: Topiramate
  • SSRI plus topiramate SSRI plus placebo

Primary Measures

• drinking - measured using the TLFB
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• craving - measured using the OCDS
  • Time Frame: 12 weeks
    Safety Issue?: No
• aggression - measured using the STAE
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Secondary Measures

• affect - measured using the Buss-Durkee Scale and Affective Intensity Scale
  • Time Frame: 12 weeks
    Safety Issue?: No
• side effects - measured using the SAFTEE
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Elizabeth Ralevski, Ph.D. Principal Investigator Yale University  

Overall Contact: Elizabeth Ralevski, Ph.D. 203-932-5711 elizabeth.ralevski@yale.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00463775

Study ID Number: 0702002346

ClinicalTrials.gov Identifier: NCT00463775

Health Authority: United States: Institutional Review Board