PET Imaging and Olanzapine Treatment in Borderline Personality Disorder
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|ClinicalTrials.gov Identifier: NCT00275301|
Recruitment Status : Completed
First Posted : January 11, 2006
Results First Posted : May 23, 2017
Last Update Posted : May 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Borderline Personality Disorder||Drug: olanzapine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Brain Correlates of Olanzapine Treatment Response in BPD|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||December 2008|
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
- 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,
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|