PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

Brain Correlates of Olanzapine Treatment Response in BPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275301
• Other study ID #: 0506M70791
• Status: Completed
• Phase: N/A
• First received: January 10, 2006
• Last updated: August 25, 2011
• Start date: December 2005
• Est. completion date: December 2008

Study information

• Verified date: August 2011
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota, Dept of Psychiatry	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		8 week study	No
Secondary	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.		8 week study	No