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Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00122070
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : June 10, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
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 secondary objective is to characterize the safety and tolerability of utilizing quetiapine in patients with Borderline Personality Disorder.

Design:

Investigator initiated, 6-week, non-placebo controlled, non-randomized, open-label, single drug, single-center, medication trial.

Participants:

Volunteers (n = 15) diagnosed with Borderline Personality Disorder using the Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II).

Interventions:

Subjects with Borderline Personality Disorder are washed out of all other medications. The subjects are then given the study drug at a dose within the drug's known therapeutic range.


Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Drug: Quetiapine Fumarate Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder
Study Start Date : May 2005
Primary Completion Date : September 2007
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
Quetiapine at dosage of 50 to 150 mg
Drug: Quetiapine Fumarate
Dosage can vary from 50 to 150 mg at PI's discretion
Other Name: Seroquel


Outcome Measures

Primary Outcome Measures :
  1. Symptom Checklist 90 scale (SCL-90-R) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Safety and tolerability will be measured at Baseline and weekly using the following scales: Simpson-Angus Extrapyramidal Side Effect Scale (SAS), Barnes Akathisia Scale (BAS), and Abnormal Involuntary Movement Scale (AIMS). [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122070


Locations
United States, New Jersey
University of Medicine and Dentistry of New Jersey - School of Osteopathic Medicine - Department of Psychiatry
Cherry Hill, New Jersey, United States, 08002-2000
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
AstraZeneca
Investigators
Principal Investigator: David J Rissmiller, DO University of Medicine and Dentistry of New Jersey - School of Osteopathic Medicine
More Information

Responsible Party: David J. Rissmiller, D.O., UMDNJ
ClinicalTrials.gov Identifier: NCT00122070     History of Changes
Other Study ID Numbers: 702787
IRUS QUET 0246
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: June 10, 2008
Last Verified: June 2008

Keywords provided by Rutgers, The State University of New Jersey:
Borderline Personality Disorder
Personality Disorder
Quetiapine
Atypical Antipsychotics
Seroquel
Antipsychotics

Additional relevant MeSH terms:
Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs