PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

Not Applicable

Completed

• Conditions: Borderline Personality Disorder
• Interventions: Drug: olanzapine

• Registration Number: NCT00275301
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-01-10
• Study First Submitted QC: 2006-01-10
• Study First Posted: 2006-01-11
• Primary Completion: 2008-04
• Study Completion: 2008-12
• Results First Submitted: 2013-08-14
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-17
• Last Update Submitted: 2017-04-17
• Results First Posted: 2017-05-23
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label Olanzapine.	olanzapine	Open-label Olanzapine.

Primary Outcome Measures

Name	Time	Method
Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan	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,

Trial Locations

Locations (1)

University of Minnesota, Dept of Psychiatry; 🇺🇸 Minneapolis, Minnesota, United States