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

This study has been withdrawn prior to enrollment.
(Recruitment not progressing as planned.)
Sponsor:
Information provided by (Responsible Party):
Elizabeth Ralevski, Yale University
ClinicalTrials.gov Identifier:
NCT00463775
First received: April 18, 2007
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Alcohol Dependence
Borderline Personality Disorder
Drug: Topiramate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • drinking - measured using the TLFB [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • craving - measured using the OCDS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • aggression - measured using the STAE [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • affect - measured using the Buss-Durkee Scale and Affective Intensity Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • side effects - measured using the SAFTEE [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: March 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Topiramate
    SSRI plus topiramate SSRI plus placebo
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).

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463775

Sponsors and Collaborators
Elizabeth Ralevski
Investigators
Principal Investigator: Elizabeth Ralevski, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Elizabeth Ralevski, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT00463775     History of Changes
Other Study ID Numbers: 0702002346, ER0001
Study First Received: April 18, 2007
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Treatment
Topiramate
Alcohol Dependence
Borderline Personality Disorder

Additional relevant MeSH terms:
Alcoholism
Borderline Personality Disorder
Disease
Personality Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes
Substance-Related Disorders
Topiramate
Anti-Obesity Agents
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014