PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00275301
First received: January 10, 2006
Last updated: August 25, 2011
Last verified: August 2011

January 10, 2006
August 25, 2011
December 2005
April 2008   (final data collection date for primary outcome measure)
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. [ Time Frame: 8 week study ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00275301 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 8 week study ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
PET Imaging and Olanzapine Treatment in Borderline Personality Disorder
Brain Correlates of Olanzapine Treatment Response in BPD

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Borderline Personality Disorder
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.
Other Name: Zyprexa
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2008
April 2008   (final data collection date for primary outcome measure)

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    
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00275301
0506M70791
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Eli Lilly and Company
Principal Investigator: S. Charles Schulz, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP