Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborator: AstraZeneca
• Treatments: Quetiapine Fumarate

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.