search
Back to results

PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
olanzapine
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline Personality Disorder, BPD, PET, olanzapine, brain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Minnesota, Dept of Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-label Olanzapine.

Arm Description

Open-label Olanzapine.

Outcomes

Primary Outcome Measures

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,

Secondary Outcome Measures

Full Information

First Posted
January 10, 2006
Last Updated
April 17, 2017
Sponsor
University of Minnesota
Collaborators
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT00275301
Brief Title
PET Imaging and Olanzapine Treatment in Borderline Personality Disorder
Official Title
Brain Correlates of Olanzapine Treatment Response in BPD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Borderline Personality Disorder, BPD, PET, olanzapine, brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-label Olanzapine.
Arm Type
Experimental
Arm Description
Open-label Olanzapine.
Intervention Type
Drug
Intervention Name(s)
olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan
Description
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,
Time Frame
Baseline to 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Charles Schulz, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota, Dept of Psychiatry
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.tara4bpd.org/bpd.html
Description
Treatment and Research Advancements Nat'l Assn for BPD

Learn more about this trial

PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

We'll reach out to this number within 24 hrs