PET Imaging and Olanzapine Treatment in Borderline Personality Disorder
Information source: University of Minnesota
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Borderline Personality Disorder
Intervention: olanzapine (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Minnesota Official(s) and/or principal investigator(s):
S. Charles Schulz, MD, Principal Investigator, Affiliation: University of Minnesota
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.
Clinical Details
Official title: Brain Correlates of Olanzapine Treatment Response in BPD
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
University of Minnesota, Dept of Psychiatry, Minneapolis, Minnesota 55454, United States
Additional Information
U of MN Dept of Psychiatry Ambulatory Research Center Treatment and Research Advancements Nat'l Assn for BPD
Starting date: December 2005
Ending date: December 2008
Last updated: April 1, 2008
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