Status:
COMPLETED
Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
AstraZeneca
Conditions:
Borderline Personality Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
Objective: The objective of this study is to quantitatively examine the efficacy of Seroquel (active ingredient quetiapine fumarate) in subjects with Borderline Personality Disorder (BPD). A secondar...
Detailed Description
Study Design: A six week, open-label, flexible dosing study using quetiapine. Subjects who qualify at Screening will then proceed to the baseline visit. If all inclusion and exclusion criteria are met...
Eligibility Criteria
Inclusion
- Provide written informed consent before beginning any study related activities
- Be between age 18 and 55 years
- Be able to speak, read and write English and follow simple instructions for completing self-rated scales
- Meet DSM-IV criteria for BPD as assessed by the Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II).
Exclusion
- Are pregnant or lactating.
- Have participated in any other studies involving investigational products within 30 days prior to entry into this study.
- Are undergoing an acute withdrawal syndrome from drugs or alcohol.
- Have an Axis I diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or Bipolar I Disorder as diagnosed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I), and pertinent subsequent for ruling out exclusionary diagnoses.
- Have an unstable medical disorder as determined by physical examination or laboratory testing. The primary investigator will be responsible for making this judgment based on the above.
- Had an unsatisfactory response to a previous adequate trial of quetiapine as judged by a study investigator.
- Patients cannot begin psychotherapy during the study period, but may continue if started prior to the study.
- Patients who are currently receiving quetiapine therapy may not undergo a washout period and then restart quetiapine in the study.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00122070
Start Date
May 1 2005
End Date
May 1 2008
Last Update
June 10 2008
Active Locations (1)
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1
University of Medicine and Dentistry of New Jersey - School of Osteopathic Medicine - Department of Psychiatry
Cherry Hill, New Jersey, United States, 08002-2000