PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

NCT ID: NCT00275301

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2008-12-31

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.

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.

Conditions

Borderline Personality Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open-label Olanzapine.

Open-label Olanzapine.

Group Type: EXPERIMENTAL

olanzapine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Zyprexa

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

S. Charles Schulz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota, Dept of Psychiatry

Minneapolis, Minnesota, United States

Countries

United States

Related Links

http://www.tara4bpd.org/bpd.html

Treatment and Research Advancements Nat'l Assn for BPD

Other Identifiers

0506M70791

Identifier Type: -

Identifier Source: org_study_id