Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463775
Status:
WITHDRAWN
Last Update Posted:
2012-01-31
First Post:
2007-04-18
Brief Title:
Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
Sponsor:
Elizabeth Ralevski
Organization:
Yale University
Study Overview
Official Title:
Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence
Status:
WITHDRAWN
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment not progressing as planned
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the present study is to evaluate the efficacy of topiramate 250mgday 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 BPDs 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ER0001 | None | None | None |