NCT00463775

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).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2007

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

2.2 years

First QC Date

April 18, 2007

Last Update Submit

January 26, 2012

Conditions

Alcohol DependenceBorderline Personality Disorder

Keywords

TreatmentTopiramateAlcohol DependenceBorderline Personality Disorder

Outcome Measures

Primary Outcomes (3)

  • drinking - measured using the TLFB

    12 weeks

  • craving - measured using the OCDS

    12 weeks

  • aggression - measured using the STAE

    12 weeks

Secondary Outcomes (2)

  • affect - measured using the Buss-Durkee Scale and Affective Intensity Scale

    12 weeks

  • side effects - measured using the SAFTEE

    12 weeks

Interventions

TopiramateDRUG

SSRI plus topiramate SSRI plus placebo

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of AD
  • Diagnosis of BPD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36375174DERIVED

MeSH Terms

Conditions

AlcoholismBorderline Personality Disorder

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPersonality Disorders

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Elizabeth Ralevski, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 20, 2007

Study Start

March 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

January 31, 2012

Record last verified: 2012-01