Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder

Completed · Phase 3

Conditions studied: Borderline Personality Disorder

In brief

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.

Key facts

Study ID

NCT00122070

Run by

University of Medicine and Dentistry of New Jersey

People needed

15

Starts

2005-05-01

Expected to finish

2008-05-01

Last updated by the study team

2008-06-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of Medicine and Dentistry of New Jersey - School of Osteopathic Medicine - Department of Psychiatry — Cherry Hill, New Jersey, United States

Full record on ClinicalTrials.gov

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