PET Imaging and Olanzapine Treatment in Borderline Personality Disorder - Full Text View

Sponsors and Collaborators:	University of Minnesota Eli Lilly and Company
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00275301

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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Brain Correlates of Olanzapine Treatment Response in BPD

Resource links provided by NLM:

MedlinePlus related topics: Nuclear Scans Personality Disorders

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by University of Minnesota:

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
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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:

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

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

Eli Lilly and Company

Investigators

Principal Investigator:

S. Charles Schulz, MD

University of Minnesota

More Information

Additional Information:

U of MN Dept of Psychiatry Ambulatory Research Center This link exits the ClinicalTrials.gov site

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

No publications provided

Responsible Party:	University of Minnesota ( S. Charles Schulz, MD )
Study ID Numbers:	0506M70791
Study First Received:	January 10, 2006
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00275301 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota:

Borderline Personality Disorder
BPD
PET
olanzapine
brain

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Olanzapine
Psychotropic Drugs
Central Nervous System Depressants
Antiemetics
Borderline Personality Disorder

Antipsychotic Agents
Serotonin Uptake Inhibitors
Serotonin
Mental Disorders
Peripheral Nervous System Agents
Personality Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Olanzapine
Antiemetics
Central Nervous System Depressants
Borderline Personality Disorder

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Pathologic Processes
Autonomic Agents
Mental Disorders
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents
Personality Disorders

ClinicalTrials.gov processed this record on September 02, 2009