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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00463775
Recruitment Status : Withdrawn (Recruitment not progressing as planned.)
First Posted : April 20, 2007
Last Update Posted : January 31, 2012
Information provided by (Responsible Party):
Elizabeth Ralevski, Yale University

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).

Condition or disease Intervention/treatment Phase
Alcohol Dependence Borderline Personality Disorder Drug: Topiramate Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
Study Start Date : March 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate

Intervention Details:
  • Drug: Topiramate
    SSRI plus topiramate SSRI plus placebo

Primary Outcome Measures :
  1. drinking - measured using the TLFB [ Time Frame: 12 weeks ]
  2. craving - measured using the OCDS [ Time Frame: 12 weeks ]
  3. aggression - measured using the STAE [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. affect - measured using the Buss-Durkee Scale and Affective Intensity Scale [ Time Frame: 12 weeks ]
  2. side effects - measured using the SAFTEE [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00463775

Sponsors and Collaborators
Elizabeth Ralevski
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Principal Investigator: Elizabeth Ralevski, Ph.D. Yale University
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Responsible Party: Elizabeth Ralevski, Assistant Professor, Yale University Identifier: NCT00463775    
Other Study ID Numbers: 0702002346
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012
Keywords provided by Elizabeth Ralevski, Yale University:
Alcohol Dependence
Borderline Personality Disorder
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Hypoglycemic Agents
Physiological Effects of Drugs