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Completed

NCT Number: NCT00275301

PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Dept of Psychiatry

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

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.

Other names: Zyprexa

Primary outcomes

  1. Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan

    Time frame: 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,

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Brain Correlates of Olanzapine Treatment Response in BPD

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 11, 2006
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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