PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Brain Correlates of Olanzapine Treatment Response in BPD

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Drug: olanzapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-45 years Diagnosis: borderline personality disorder by DSM-IV criteria Gender: Female May have history of substance use and other Axis II disorders Exclusion Criteria: Axis I diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder during the subject's lifetime. No current major depression or PTSD. Treatment with psychotropic medication in the previous month. Medical disorder that would influence outcome of the study - e.g. epilepsy, thyroid disease, HIV, etc. Medical disorder that would not allow use of olanzapine Active substance abuse or dependence Previous adverse reaction to olanzapine Females whom are pregnant or nursing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-label Olanzapine.<br>Open-label Olanzapine. | Drug: olanzapine<br>* 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.<br>* Other names: Zyprexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan | 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, | Baseline to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Borderline Personality Disorder, BPD, PET, olanzapine, brain