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This study has been withdrawn prior to enrollment.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

April 18, 2007
January 26, 2012
March 2007
May 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • drinking - measured using the TLFB
  • craving - measured using the OCDS
  • aggression - measured using the STAE
Complete list of historical versions of study NCT00463775 on ClinicalTrials.gov Archive Site
  • 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 ]
  • affect - measured using the Buss-Durkee Scale and Affective Intensity Scale
  • side effects - measured using the SAFTEE
Not Provided
Not Provided
 
Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
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).

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Alcohol Dependence
  • Borderline Personality Disorder
Drug: Topiramate
SSRI plus topiramate SSRI plus placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
21 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00463775
0702002346, ER0001
No
Elizabeth Ralevski, Yale University
Elizabeth Ralevski
Not Provided
Principal Investigator: Elizabeth Ralevski, Ph.D. Yale University
Yale University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP