We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00275301
First Posted: January 11, 2006
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
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.

Condition Intervention
Borderline Personality Disorder Drug: olanzapine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brain Correlates of Olanzapine Treatment Response in BPD

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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,


Enrollment: 19
Study Start Date: December 2005
Study Completion Date: December 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-label Olanzapine.
Open-label Olanzapine.
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.
Other Name: Zyprexa

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275301


Locations
United States, Minnesota
University of Minnesota, Dept of Psychiatry
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Eli Lilly and Company
Investigators
Principal Investigator: S. Charles Schulz, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00275301     History of Changes
Other Study ID Numbers: 0506M70791
First Submitted: January 10, 2006
First Posted: January 11, 2006
Results First Submitted: August 14, 2013
Results First Posted: May 23, 2017
Last Update Posted: May 23, 2017
Last Verified: April 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Borderline Personality Disorder
BPD
PET
olanzapine
brain

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents