Borderline Personality Disorder
Conditions
Keywords
Borderline Personality Disorder, BPD, PET, olanzapine, brain
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.
Interventions
DRUGolanzapine
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.
Sponsors
Eli Lilly and Company
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan | 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, |
Countries
United States
Participant flow
Recruitment details
All subjects were symptomatic volunteers from the community.
Pre-assignment details
19 subjects were enrolled. 5 early withdrawals. 14 subjects completed the entire study.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Were Open-label and Took the Same Dose. This was an open-label study so all subjects were in the same group. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
Baseline characteristics
| Characteristic | All Subjects Were Open-label and Took the Same Dose. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 26.4 years STANDARD_DEVIATION 7.56 |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
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,
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects Were Open-label and Took the Same Dose. | Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan | 11.5 Standard uptake value | Standard Deviation 0.5 |
Comparison: Examination of relationship between Borderline Personality Disorder symptoms and brain metabolism at baseline.p-value: <0.05Regression, Linear