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Sponsored by: |
Yale University |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00463775 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence |
Estimated Enrollment: | 30 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
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).
Ages Eligible for Study: | 21 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elizabeth Ralevski, Ph.D. | 203-932-5711 ext 4282 | elizabeth.ralevski@yale.edu |
United States, Connecticut | |
VA Connecticut Healthcare System | Recruiting |
West Haven, Connecticut, United States, 06516 | |
Contact: Elizabeth Ralevski, Ph.D. 203-932-5711 ext 4282 elizabeth.ralevski@yale.edu |
Principal Investigator: | Elizabeth Ralevski, Ph.D. | Yale University |
Responsible Party: | Yale University ( Elizabeth Ralevski, Ph.D. ) |
Study ID Numbers: | 0702002346, ER0001 |
Study First Received: | April 18, 2007 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00463775 |
Health Authority: | United States: Institutional Review Board |
Treatment Topiramate Alcohol Dependence Borderline Personality Disorder |
Mental Disorders Alcoholism Substance-Related Disorders Topiramate Disorders of Environmental Origin |
Alcohol-Related Disorders Borderline Personality Disorder Ethanol Personality Disorders |
Anti-Obesity Agents Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs |
Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |