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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label Olanzapine. | Experimental | Open-label Olanzapine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| S. Charles Schulz, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota, Dept of Psychiatry | Minneapolis | Minnesota | 55454 | United States |
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| Label | URL |
|---|---|
| Treatment and Research Advancements Nat'l Assn for BPD | View source |
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19 subjects were enrolled. 5 early withdrawals. 14 subjects completed the entire study.
All subjects were symptomatic volunteers from the community.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects Took Open-label Olanzapine. | All subjects took open-label olanzapine. Subjects tritrated to up to 10mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
19 subjects were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects Were Open-label and Took the Same Dose. | This was an open-label study so all subjects were in the same group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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, | Posted | Mean | Standard Deviation | Standard uptake value | Baseline to 8 weeks |
|
|
8 weeks
All subjects took open-label olanzapine.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects Were Open-label and Took the Same Dose. | This was an open-label study so all subjects were in the same group. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | Nervous system disorders | Medra | Systematic Assessment | All 14 subjects reported sedation. |
Small number of subjects (14) analyzed. 19 subjects were enrolled but 5 subjects withdrew early from the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| S. Charles Schulz, MD | University of Minnesota | 612-273-9820 | scs@umn.edu |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 14 |
| 14 |
| 14 |
|
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| D006571 | Heterocyclic Compounds |