PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

University of Minnesota (UMN)

Status: Completed

Conditions: Borderline Personality Disorder

Treatments: Drug: olanzapine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00275301

0506M70791

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Open-label Olanzapine.

Experimental group

Description:

Open-label Olanzapine.

Treatment:

Drug: olanzapine