Borderline Personality Disorder, Impulse Control Disorders
Conditions
Brief summary
This study aims to use resting-state and task based functional Magnetic Resonance Imaging (fMRI) as a tool to evaluate trait characteristics of impulsivity in subjects with borderline personality disorder.
Interventions
BEHAVIORALExperimental
with functional imaging and behavioural measurements at baseline and 4 weeks
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Controls: Volunteers (age 18-50 yrs) in generally good Psychiatric and non-Psychiatric medical health * Borderline Personality Disorder subjects: Research volunteers (age 18-50 yrs) who meet DSM-5 criteria for Borderline Personality Disorder
Exclusion criteria
All Participants: * Current medications which affect the central nervous system or vascular activity, such as anti-depressants, anxiolytics, or blood-pressure medications * Positive urine drug screen for cocaine, opioids, amphetamine, and benzodiazepines * Positive breathalyzer test for alcohol * History of clinically significant neurologic disorders or head trauma with loss of consciousness greater than 30 minutes * Clinically significant non-psychiatric medical disorder requiring ongoing treatment. * Unwillingness or inability to sign a written informed consent form * Pregnancy as assessed by a urine test for ß-HCG at each visit * Medical or physical contraindications for participation based on medical history interview, labs, and physical exam * Metal fragments or other bodily metal (e.g., pacemaker, orthopedic prosthesis),claustrophobia, or any other condition that would put the subjects at risk for MRI scanning In addition, Healthy Controls excluded, if: * DSM-5 diagnoses of Personality Disorders (based on SCID-II) * DSM-5 diagnoses based on the SCID-I (including the eating disorders module) * History of arrest or incarceration In addition, Borderline Personality Disorder Subjects excluded if: * DSM-5 diagnoses * DSM-5 Personality Disorder other than Cluster B Personality disorders * Current psychoactive medications * Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Affective Faces Task (AFT) fMRI response | up to 5 weeks |
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Monetary Incentive Delay (MID) fMRI task response | up to 5 weeks |
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for resting-state functional magnetic resonance imaging (fMRI) activity | up to 5 weeks |
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Go/ No Go functional magnetic resonance imaging (fMRI) response | up to 5 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Barratt Impulsiveness Scale v.11 (BIS-11) | up to 5 weeks |
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Profile of Mood States behavioral test | up to 5 weeks |
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Go/ No Go task behavioral test | up to 5 weeks |
| Change from baseline to 4 week follow-up visit for Eye Tracking | up to 5 weeks |
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency (UPPS-P) Impulsive behavior Scale, subscale for perseverance | up to 5 weeks |
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency (UPPS-P) Impulsive behavior Scale, subscale for sensation seeking | up to 5 weeks |
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency (UPPS-P) Impulsive behavior Scale, subscale for urgency | up to 5 weeks |
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency (UPPS-P) Impulsive behavior Scale, subscale for premeditation | up to 5 weeks |
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Immediate Memory Task (IMT) behavioral test | up to 5 weeks |
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Computerized monetary choice procedure behavioral test | up to 5 weeks |
| Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Stop-signal paradigm behavioral test | up to 5 weeks |
Countries
United States
Outcome results
None listed