PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

• ClinicalTrials.gov Identifier: NCT00275301
• Recruitment Status: Completed
• First Posted: January 11, 2006
• Results First Posted: May 23, 2017
• Last Update Posted: May 23, 2017
• Sponsor: University of Minnesota
• Collaborator: Eli Lilly and Company
• Information provided by (Responsible Party): University of Minnesota

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Borderline Personality Disorder	Drug: olanzapine	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Brain Correlates of Olanzapine Treatment Response in BPD
• Study Start Date: December 2005
• Actual Primary Completion Date: April 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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,

Eligibility Criteria

• 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

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:

Treatment and Research Advancements Nat'l Assn for BPD 

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT00275301
• Other Study ID Numbers: 0506M70791
• First Posted: January 11, 2006
• Results First Posted: May 23, 2017
• Last Update Posted: May 23, 2017
• Last Verified: April 2017

Keywords provided by University of Minnesota:

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