Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder

NCT00122070 | Completed Phase 3 DMC

• 2 other identifiers: 702787IRUS QUET 0246
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Borderline Personality Disorder

Keywords

Borderline Personality Disorder; Personality Disorder; Quetiapine; Atypical Antipsychotics; Seroquel; Antipsychotics

Outcome Measures

Primary Outcomes (1)

• Symptom Checklist 90 scale (SCL-90-R)

  8 weeks

Secondary Outcomes (1)

• 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).

  8 weeks

Study Arms (1)

A

EXPERIMENTAL

Quetiapine at dosage of 50 to 150 mg

Drug: Quetiapine Fumarate

Interventions

Quetiapine Fumarate DRUG

Dosage can vary from 50 to 150 mg at PI's discretion

Also known as: Seroquel

A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 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.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Medicine and Dentistry of New Jersey - School of Osteopathic Medicine - Department of Psychiatry

Cherry Hill, New Jersey, 08002-2000, United States

Location

MeSH Terms

Conditions

Borderline Personality Disorder; Personality Disorders

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David J Rissmiller, DO

  University of Medicine and Dentistry of New Jersey - School of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 15, 2005
• First Posted: July 21, 2005
• Study Start: May 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: May 1, 2008
• Last Updated: June 10, 2008

Record last verified: 2008-06

Locations

US (1)