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Sponsors and Collaborators: |
University of Medicine and Dentistry New Jersey AstraZeneca |
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Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00122070 |
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 |
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
|
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | David J Rissmiller, DO | University of Medicine and Dentistry of New Jersey - School of Osteopathic Medicine |
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 |
Borderline Personality Disorder Personality Disorder Quetiapine |
Atypical Antipsychotics Seroquel Antipsychotics |
Quetiapine Tranquilizing Agents Mental Disorders Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Borderline Personality Disorder Personality Disorders |
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 |