Trial Outcomes & Findings for PET Imaging and Olanzapine Treatment in Borderline Personality Disorder (NCT NCT00275301)

NCT ID: NCT00275301

Last Updated: 2017-05-23

Results Overview

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,

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: Baseline to 8 weeks
• Results posted on: 2017-05-23

Participant Flow

All subjects were symptomatic volunteers from the community.

19 subjects were enrolled. 5 early withdrawals. 14 subjects completed the entire study.

Participant milestones

Measure	All Subjects Took Open-label Olanzapine. All subjects took open-label olanzapine. Subjects tritrated to up to 10mg
Overall Study STARTED	19
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	All Subjects Took Open-label Olanzapine. All subjects took open-label olanzapine. Subjects tritrated to up to 10mg
Overall Study Adverse Event	5

Baseline Characteristics

PET Imaging and Olanzapine Treatment in Borderline Personality Disorder

Baseline characteristics by cohort

Measure	All Subjects Were Open-label and Took the Same Dose. n=19 Participants This was an open-label study so all subjects were in the same group.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	26.4 years STANDARD_DEVIATION 7.56 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 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,

Outcome measures

Measure	All Subjects Were Open-label and Took the Same Dose. n=19 Participants This was an open-label study so all subjects were in the same group.
Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan	11.5 Standard uptake value Standard Deviation .5

Adverse Events

All Subjects Were Open-label and Took the Same Dose.

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Subjects Were Open-label and Took the Same Dose. n=14 participants at risk This was an open-label study so all subjects were in the same group.
Nervous system disorders Sedation	100.0% 14/14 • Number of events 20 • 8 weeks All subjects took open-label olanzapine.

Additional Information

S. Charles Schulz, MD

University of Minnesota

Phone: 612-273-9820

Email: scs@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place