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PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00275301
First Posted: January 11, 2006
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
Results First Submitted: August 14, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Borderline Personality Disorder
Intervention: Drug: olanzapine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All subjects were symptomatic volunteers from the community.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
19 subjects were enrolled. 5 early withdrawals. 14 subjects completed the entire study.

Reporting Groups
  Description
All Subjects Took Open-label Olanzapine. All subjects took open-label olanzapine. Subjects tritrated to up to 10mg

Participant Flow:   Overall Study
    All Subjects Took Open-label Olanzapine.
STARTED   19 
COMPLETED   14 
NOT COMPLETED   5 
Adverse Event                5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
19 subjects were enrolled.

Reporting Groups
  Description
All Subjects Were Open-label and Took the Same Dose. This was an open-label study so all subjects were in the same group.

Baseline Measures
   All Subjects Were Open-label and Took the Same Dose. 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      19 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.4  (7.56) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      14  73.7% 
Male      5  26.3% 
Region of Enrollment 
[Units: Participants]
 
United States   19 


  Outcome Measures

1.  Primary:   Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan   [ Time Frame: Baseline to 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small number of subjects (14) analyzed. 19 subjects were enrolled but 5 subjects withdrew early from the study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: S. Charles Schulz, MD
Organization: University of Minnesota
phone: 612-273-9820
e-mail: scs@umn.edu



Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00275301     History of Changes
Other Study ID Numbers: 0506M70791
First Submitted: January 10, 2006
First Posted: January 11, 2006
Results First Submitted: August 14, 2013
Results First Posted: May 23, 2017
Last Update Posted: May 23, 2017