Borderline Personality DisorderNCT00275301
PET Imaging and Olanzapine Treatment in Borderline Personality Disorder
A study testing olanzapine in people with Borderline Personality Disorder, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, Dept of Psychiatry
Minneapolis, Minnesota, 55454
About this study
Official title: Brain Correlates of Olanzapine Treatment Response in BPD
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.
Read the 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- olanzapine
- Keywords
- Borderline Personality Disorder, BPD, PET, olanzapine, brain
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
Also called Zyprexa
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.
| Study group | Role | What they receive |
|---|---|---|
| Open-label Olanzapine. | Experimental | Open-label Olanzapine. Receives: Drug: olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionApr 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- S. Charles Schulz, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275301
- Sponsor's protocol ID
- 0506M70791
- Status last verified
- Apr 2017
- First submitted
- 10 Jan 2006
- Last updated
- 23 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Correlates of Olanzapine Treatment Response in BPD
- ClinicalTrials.gov ID
- NCT00275301
- Acronym / sponsor ID
- 0506M70791
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline Personality Disorder, BPD, PET, olanzapine, brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Dec 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Jan 2006 (estimated)
- Results
- Posted 23 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label Olanzapine. | Experimental | Drug: olanzapineOpen-label Olanzapine. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olanzapineAlso: ZyprexaOlanzapine 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. | Drug | Open-label Olanzapine. |
Primary outcome
Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan
Time frame: 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,
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Treatment and Research Advancements Nat'l Assn for BPDLink provided by the sponsor.
Related trials for Borderline Personality Disorder
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Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
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Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
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Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. Charles Schulz, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olanzapine in people with Borderline Personality Disorder, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.