PET Imaging and Olanzapine Treatment in Borderline Personality Disorder
Overview
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.
Full Title of Study: “Brain Correlates of Olanzapine Treatment Response in BPD”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: April 2008
Detailed Description
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.
Interventions
- 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.
Arms, Groups and Cohorts
- Experimental: Open-label Olanzapine.
- Open-label Olanzapine.
Clinical Trial Outcome Measures
Primary Measures
- Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan
- Time Frame: Baseline to 8 weeks
- The primary aim of this imaging study was to examine the effect of olanzapine on brain metabolism over the eight weeks of administration. To compare the baseline PET scan to the endpoint scan,
Participating in This Clinical Trial
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: Female
Minimum Age: 18 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- University of Minnesota
- Collaborator
- Eli Lilly and Company
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- S. Charles Schulz, MD, Principal Investigator, University of Minnesota
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.