Official Title: “Brain Correlates of Olanzapine Treatment Response in BPD”

The overall design of the study is to perform both a PET and MRI scan on objectively identified borderline personality disorder patients, to treat them with olanzapine for 8 weeks, and to then re-scan the patients with PET.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: April 2008

The primary objective of this proposed study will be to compare the baseline PET scan to the endpoint scan in 15 BPD patients who have been treated with olanzapine. The comparison of the scans will be done through a statistical image analysis, using a pixel-by-pixel group mean subtraction strategy with appropriate correction for multiple comparisons. In an exploratory fashion we will compare frontal and temporal regions of interest to address hypotheses of which areas of the brain might show changes with olanzapine treatment.

A secondary objective is to use a normal database to compare the baseline PET scan of the 15 patients in a medication free state to normal subjects. The advantage of this strategy is the ability to closely match subjects by gender and age. As noted earlier, Dr. Pardo has data on 35 control subjects studied on the same scanner we plan to use for this study.

Intervention(s) in this Clinical Trial

• Drug: olanzapine
  • Olanzapine 2.5mg by mouth at bedtime x2 weeks, then Olanzapine 5mg by mouth at bedtime x2 weeks, then Olanzapine 7.5mg by mouth at bedtime x4 weeks.

Primary Measures

• The primary objective of this proposed study will be to compare the baseline PET scan to the endpoint scan in 15 BPD patients who have been treated with olanzapine. The comparison of the scans will be done through a statistical image analysis.
  • Time Frame: 8 week study
    Safety Issue?: No

Secondary Measures

• A secondary objective is to use a normal database to compare the baseline PET scan of the 15 patients in a medication free state to normal subjects. The advantage of this strategy is the ability to closely match subjects by gender and age.
  • Time Frame: 8 week study
    Safety Issue?: No

Inclusion Criteria:

• 1. Age 18-45 years
• 2. Diagnosis: borderline personality disorder by DSM-IV criteria
• 3. Gender: Female
• 4. May have history of substance use and other Axis II disorders

Exclusion Criteria:

• 1. Axis I diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder during the subject's lifetime. No current major depression or PTSD.
• 2. Treatment with psychotropic medication in the previous month.
• 3. Medical disorder that would influence outcome of the study - e.g. epilepsy, thyroid disease, HIV, etc.
• 4. Medical disorder that would not allow use of olanzapine
• 5. Active substance abuse or dependence
• 6. Previous adverse reaction to olanzapine
• 7. Females whom are pregnant or nursing    

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Minnesota

Overall Clinical Trial Officials and Contacts

S. Charles Schulz, MD Principal Investigator University of Minnesota  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00275301

Study ID Number: 0506M70791

ClinicalTrials.gov Identifier: NCT00275301

Health Authority: United States: Institutional Review Board

U of MN Dept of Psychiatry Ambulatory Research Center

Treatment and Research Advancements Nat'l Assn for BPD