Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder - Full Text View

Sponsor:	University of Medicine and Dentistry New Jersey
Collaborator:	AstraZeneca
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00122070

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder

Resource links provided by NLM:

MedlinePlus related topics: Personality Disorders

Drug Information available for: Quetiapine Quetiapine fumarate

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
A: Experimental Quetiapine at dosage of 50 to 150 mg	Drug: Quetiapine Fumarate Dosage can vary from 50 to 150 mg at PI's discretion

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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:	UMDNJ ( David J. Rissmiller, D.O. )
Study ID Numbers:	702787, IRUS QUET 0246
Study First Received:	July 15, 2005
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00122070 History of Changes
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:

Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Borderline Personality Disorder
Antipsychotic Agents

Pharmacologic Actions
Quetiapine
Pathologic Processes
Mental Disorders
Therapeutic Uses
Central Nervous System Agents
Personality Disorders

ClinicalTrials.gov processed this record on February 08, 2010