Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
Primary Purpose
Alcohol Dependence, Borderline Personality Disorder
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Topiramate
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Treatment, Topiramate, Alcohol Dependence, Borderline Personality Disorder
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
drinking - measured using the TLFB
craving - measured using the OCDS
aggression - measured using the STAE
Secondary Outcome Measures
affect - measured using the Buss-Durkee Scale and Affective Intensity Scale
side effects - measured using the SAFTEE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00463775
Brief Title
Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
Official Title
Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment not progressing as planned.
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elizabeth Ralevski
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Borderline Personality Disorder
Keywords
Treatment, Topiramate, Alcohol Dependence, Borderline Personality Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Topiramate
Intervention Description
SSRI plus topiramate SSRI plus placebo
Primary Outcome Measure Information:
Title
drinking - measured using the TLFB
Time Frame
12 weeks
Title
craving - measured using the OCDS
Time Frame
12 weeks
Title
aggression - measured using the STAE
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
affect - measured using the Buss-Durkee Scale and Affective Intensity Scale
Time Frame
12 weeks
Title
side effects - measured using the SAFTEE
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Ralevski, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
36375174
Citation
Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
Results Reference
derived
Learn more about this trial
Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
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