Borderline Personality DisorderNCT00275288
MRI Imaging in Borderline Personality Disorder
An observational study of Borderline Personality Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
MRI Study for females ages 18-45 with Borderline Personality Disorder(BPD): This study is a non-treatment study that involves 2 visits. Study Hypothesis: 1. To refine and pilot test functional neuroimaging paradigms to assess the amygdala response to neutral facial expressions across positive and negative emotional… 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
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: 20 Female subjects ages 18-45 whom meet criteria for BPD will be included in the study. 20 healthy controls will also be females between the ages 18-45.
Who may be able to join
- Female subjects ages 18-45 whom meet criteria for BPD will be included in the study. The healthy controls will also be females between the ages 18-45. The healthy controls will undergo the same diagnostic and symptom evaluations as the female patients - these interview schedules will be used mainly for determining exclusion criteria.
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Who cannot join
- Neither borderline personality disorder subjects or healthy controls may have a history of schizophrenia, schizoaffective disorder, bipolar illness, major depression with psychotic features, Obsessive-Compulsive Disorder (OCD), Post-Traumatic Stress Disorder (PTSD), or Generalized Anxiety Disorder (GAD).
- Patients and healthy controls may not have a serious neurologic or other metabolic disorder or any medical condition or treatment known to affect the parameters of this study.
- Neither patients nor healthy controls will be included in the study if they are receiving a medical treatment that requires a medication that may have psychotropic effects.
- Neither patients nor healthy controls can have any contraindications to MRI scanning such as a metal implant, a pacemaker, or a history of claustrophobia. At the Center for Magnetic Resonance Research (CMRR), we have developed a highly specific and detailed questionnaire to ensure the safety of all participants. This questionnaire is administered prior to any and all scans.
- Pregnant women will be excluded from the study. This will be assessed by history, date of last menstrual period and urine pregnancy test if necessary.
- Neither patients nor healthy controls who fulfill criteria for developmental deficiency will be included.
- Healthy controls with more than two borderline personality disorder criteria will not be eligible for study. This is to reduce the possibility of healthy controls being "near misses" to the patients and diminishing the possibility of finding difference between the patients and the healthy controls.
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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 Affect Regulation In BPD"
MRI Study for females ages 18-45 with Borderline Personality Disorder(BPD): This study is a non-treatment study that involves 2 visits. Study Hypothesis:
- To refine and pilot test functional neuroimaging paradigms to assess the amygdala response to neutral facial expressions across positive and negative emotional contexts.
- To assess whether patients with borderline personality disorder show a heightened amygdala response to neutral facial expressions relative to healthy controls (20 female healthy controls, 20 females with borderline personality disorder).
- To assess the relationship between individual differences in clinical ratings of personality and affective regulation, and the amygdala response to facial expressions.
Read the detailed description
The first visit will be an interview assessment and will take place at the Ambulatory Research Center (ARC), Fairview University-Riverside Campus. In addition to the interview assessment, we will ask you to complete a set of questionnaires about your behavior and mood. This first visit will last approximately 2.5-3 hours. Following the interview assessment, if you are eligible for the MRI study we will contact you to schedule an MRI scan on a separate visit. This visit will last approximately 2 hours. At this visit you will have an MRI scan of your brain. Prior to the MRI scan, you will have a practice session in an MRI simulator.
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline Personality Disorder, BPD, amygdala, facial expression response, MRI
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Normal | Not described | |
| Active Disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To refine and pilot test functional neuroimaging paradigms to assess the amygdala response to neutral facial expressions across positive and negative emotional contexts.
- To refine and pilot test functional neuroimaging paradigms to assess the amygdala response to neutral facial expressions across positive and negative emotional contexts.
- To assess whether patients with borderline personality disorder show a heightened amygdala response to neutral facial expressions relative to healthy controls (20 female healthy controls, 20 females with borderline personality disorder).
- To assess the relationship between individual differences in clinical ratings of personality and affective regulation, and the amygdala response to facial expressions
Measured: 2 years
Secondary outcomes (1)
Secondary Outcomes
- To assess whether patients with borderline personality disorder show a heightened amygdala response to neutral facial expressions relative to healthy controls (20 female healthy controls, 20 females with borderline personality disorder).
- To assess the relationship between individual differences in clinical ratings of personality and affective regulation, and the amygdala response to facial expressions.
Measured: 2 years
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 startJan 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- Kathleen M Thomas, PhD, Study director, Asst Professor, Institute of Child Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275288
- Sponsor's protocol ID
- 0407M62321
- Status last verified
- Nov 2010
- First submitted
- 10 Jan 2006
- Last updated
- 2 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Brain Correlates Of Affect Regulation In BPD"
- ClinicalTrials.gov ID
- NCT00275288
- Acronym / sponsor ID
- 0407M62321
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline Personality Disorder, BPD, amygdala, facial expression response, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 11 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MRI Study for females ages 18-45 with Borderline Personality Disorder(BPD): This study is a non-treatment study that involves 2 visits. Study Hypothesis:
- To refine and pilot test functional neuroimaging paradigms to assess the amygdala response to neutral facial expressions across positive and negative emotional contexts.
- To assess whether patients with borderline personality disorder show a heightened amygdala response to neutral facial expressions relative to healthy controls (20 female healthy controls, 20 females with borderline personality disorder).
- To assess the relationship between individual differences in clinical ratings of personality and affective regulation, and the amygdala response to facial expressions.
Detailed description
The first visit will be an interview assessment and will take place at the Ambulatory Research Center (ARC), Fairview University-Riverside Campus. In addition to the interview assessment, we will ask you to complete a set of questionnaires about your behavior and mood. This first visit will last approximately 2.5-3 hours. Following the interview assessment, if you are eligible for the MRI study we will contact you to schedule an MRI scan on a separate visit. This visit will last approximately 2 hours. At this visit you will have an MRI scan of your brain. Prior to the MRI scan, you will have a practice session in an MRI simulator.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Normal | – | – |
| Active Disease | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 20 Female subjects ages 18-45 whom meet criteria for BPD will be included in the study. 20 healthy controls will also be females between the ages 18-45.
Key inclusion criteria (2 listed)
- Female subjects ages 18-45 whom meet criteria for BPD will be included in the study. The healthy controls will also be females between the ages 18-45. The healthy controls will undergo the same diagnostic and symptom evaluations as the female patients - these interview schedules will be used mainly for determining exclusion criteria.
- -
Key exclusion criteria (8 listed)
- Neither borderline personality disorder subjects or healthy controls may have a history of schizophrenia, schizoaffective disorder, bipolar illness, major depression with psychotic features, Obsessive-Compulsive Disorder (OCD), Post-Traumatic Stress Disorder (PTSD), or Generalized Anxiety Disorder (GAD).
- Patients and healthy controls may not have a serious neurologic or other metabolic disorder or any medical condition or treatment known to affect the parameters of this study.
- Neither patients nor healthy controls will be included in the study if they are receiving a medical treatment that requires a medication that may have psychotropic effects.
- Neither patients nor healthy controls can have any contraindications to MRI scanning such as a metal implant, a pacemaker, or a history of claustrophobia. At the Center for Magnetic Resonance Research (CMRR), we have developed a highly specific and detailed questionnaire to ensure the safety of all participants. This questionnaire is administered prior to any and all scans.
- Pregnant women will be excluded from the study. This will be assessed by history, date of last menstrual period and urine pregnancy test if necessary.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To refine and pilot test functional neuroimaging paradigms to assess the amygdala response to neutral facial expressions across positive and negative emotional contexts.
Time frame: 2 years
1. To refine and pilot test functional neuroimaging paradigms to assess the amygdala response to neutral facial expressions across positive and negative emotional contexts. 2. To assess whether patients with borderline personality disorder show a heightened amygdala response to neutral facial expressions relative to healthy controls (20 female healthy controls, 20 females with borderline personality disorder). 3. To assess the relationship between individual differences in clinical ratings of personality and affective regulation, and the amygdala response to facial expressions
1 secondary outcome
Secondary Outcomes
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2010.
- Treatment and Research Advancements Nat'l Assn for BPDLink provided by the sponsor.
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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.
Kathleen M Thomas, PhD study director
Asst Professor, Institute of Child Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 8 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 2 Nov 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To refine and pilot test functional neuroimaging paradigms to assess the amygdala response to neutral facial expressions across positive and negative emotional contexts. (time frame: 2 years). 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 2 Nov 2010.