MRI Imaging in Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

"Brain Correlates Of Affect Regulation In BPD"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275288
• Other study ID #: 0407M62321
• Status: Completed
• Phase: N/A
• First received: January 10, 2006
• Last updated: November 1, 2010
• Start date: January 2005
• Est. completion date: June 2007

Study information

• Verified date: November 2010
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

1. 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).

2. 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.

3. 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.

4. 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.

5. 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.

6. Neither patients nor healthy controls who fulfill criteria for developmental deficiency will be included.

7. 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Locations

Country	Name	City	State
United States	University of Minnesota, Dept of Psychiatry	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years	No
Secondary	Secondary Outcomes	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.	2 years	No