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Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00122070
First received: July 15, 2005
Last updated: June 9, 2008
Last verified: June 2008
History of Changes
  Purpose

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 Intervention Phase
Borderline Personality Disorder
 Drug: Quetiapine Fumarate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Symptom Checklist 90 scale (SCL-90-R) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: May 2005
Study Completion Date: May 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 New Jersey
AstraZeneca
Investigators
Principal Investigator: David J Rissmiller, DO University of Medicine and Dentistry of New Jersey - School of Osteopathic Medicine
  More Information

No publications provided

Responsible Party: David J. Rissmiller, D.O., UMDNJ
ClinicalTrials.gov Identifier: NCT00122070     History of Changes
Other Study ID Numbers: 702787, IRUS QUET 0246
Study First Received: July 15, 2005
Last Updated: June 9, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Medicine and Dentistry New Jersey:
Borderline Personality Disorder
Personality Disorder
Quetiapine
 Atypical Antipsychotics
Seroquel
Antipsychotics

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013