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PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00275301
First received: January 10, 2006
Last updated: August 25, 2011
Last verified: August 2011
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Brain Correlates of Olanzapine Treatment Response in BPD

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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. [ Time Frame: 8 week study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 8 week study ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: December 2005
Study Completion Date: December 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Treatment and Research Advancements Nat'l Assn for BPD  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00275301     History of Changes
Other Study ID Numbers: 0506M70791
Study First Received: January 10, 2006
Last Updated: August 25, 2011
Health Authority: United States: Institutional Review Board

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
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013