Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00275301
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2006-01-10
Brief Title:
PET Imaging and Olanzapine Treatment in Borderline Personality Disorder
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Brain Correlates of Olanzapine Treatment Response in BPD
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None