PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

NCT00275301 | Completed Results

• 1 other identifier: 0506M70791
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Keywords

Borderline Personality Disorder; BPD; PET; olanzapine; brain

Outcome Measures

Primary Outcomes (1)

• Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan

  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,

  Baseline to 8 weeks

Study Arms (1)

Open-label Olanzapine.

EXPERIMENTAL

Open-label Olanzapine.

Drug: olanzapine

Interventions

olanzapine 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.

Also known as: Zyprexa

Open-label Olanzapine.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Minnesota, Dept of Psychiatry

Minneapolis, Minnesota, 55454, United States

Location

Related Links

• Treatment and Research Advancements Nat'l Assn for BPD

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Small number of subjects (14) analyzed. 19 subjects were enrolled but 5 subjects withdrew early from the study.

Results Point of Contact

• Title: S. Charles Schulz, MD
• Organization: University of Minnesota

scs@umn.edu

612-273-9820

Study Officials

• S. Charles Schulz, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: December 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 23, 2017
• Results First Posted: May 23, 2017

Record last verified: 2017-04

Locations

US (1)