Clinical Trial: Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder

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.


Detailed Summary:

Study Design: A six week, open-label, flexible dosing study using quetiapine. Subjects who qualify at Screening will then proceed to the baseline visit. If all inclusion and exclusion criteria are met, subjects will be administered quetiapine at the baseline visit. Enrollment will be 15 subjects. Enrollment is expected to last for a 6 month period.

Study Flow Sheet

Duration of Study and Visit Schedule. The subjects will have visits at the following intervals:

  • Screening (Day -1 to -14)
  • Visit 1 (Baseline)
  • Visit 2 (Week 1)
  • Visit 3 (Week 2)
  • Visit 4 (Week 3)
  • Visit 5 (Week 4)
  • Visit 6 (Week 5)
  • Visit 7 (Week 6)

Screening visit (Day -1 to -14): The following procedures will be performed:

  1. Review of Inclusion and Exclusion criteria
  2. Informed consent: Subject will be enrolled after signing an IRB approved informed consent. A signed copy will be given to the subject.
  3. Review of Concomitant Medications
  4. Medical/Disease History & Physical Exam, Vital Signs: The subject will have a H&P administered by an investigator. Weight, TPR, BP will be assessed. This will be done in Family medicine by Dr. Robert Hudrick, DO or Dr. Andrea Woll, DO.
  5. A 12 Lead EKG will be done in Family medicine by Dr. Robert Hudrick, DO or Dr. Andrea Woll, DO.
    6. Sponsor: University of Medicine and Dentistry of New Jersey

    Current Primary Outcome: Symptom Checklist 90 scale (SCL-90-R) [ Time Frame: 8 weeks ]

    Original Primary Outcome:

    • Symptom Checklist 90 scale (SCL-90-R)
    • Beck Depression Inventory (BDI-II)
    • Beck Anxiety Inventory (BAI)
    • Buss-Durkee Hostility Inventory (BDHI)
    • Global Assessment of Functioning (GAF)
    • Clinical Global Impression Scale (CGI)


    Current Secondary Outcome: 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 ]

    Original Secondary Outcome:

    • Safety and Tolerability:
    • Baseline and weekly:
    • Simpson–Angus Extrapyramidal Side Effect Scale (SAS)
    • Barnes Akathisia Scale (BAS)
    • Abnormal Involuntary Movement Scale (AIMS)


    Information By: Rutgers, The State University of New Jersey

    Dates:
    Date Received: July 15, 2005
    Date Started: May 2005
    Date Completion:
    Last Updated: June 9, 2008
    Last Verified: June 2008