PET Imaging and Olanzapine Treatment in Borderline Personality Disorder
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Brain Correlates of Olanzapine Treatment Response in BPD|
- 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,
|Study Start Date:||December 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Experimental: Open-label 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.
Other Name: Zyprexa
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275301
|United States, Minnesota|
|University of Minnesota, Dept of Psychiatry|
|Minneapolis, Minnesota, United States, 55454|
|Principal Investigator:||S. Charles Schulz, MD||University of Minnesota - Clinical and Translational Science Institute|