Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Dependence; Borderline Personality Disorder
Intervention: Topiramate (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Elizabeth Ralevski Official(s) and/or principal investigator(s): Elizabeth Ralevski, Ph.D., Principal Investigator, Affiliation: Yale University
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).
Clinical Details
Official title: Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: drinking - measured using the TLFBcraving - measured using the OCDS aggression - measured using the STAE
Secondary outcome: affect - measured using the Buss-Durkee Scale and Affective Intensity Scaleside effects - measured using the SAFTEE
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
Minimum age: 21 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: March 2007
Last updated: January 26, 2012
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