Clinical trial NCT02755181: fMRI in Impulsivity
Official title: Assessment of Longitudinal Functional Magnetic Resonance Imaging (fMRI) as a Brain Measure for Impulsivity in a Borderline Personality Disorder (BPD) Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impulse Control Disorders
Borderline Personality Disorder
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BPD and normal volunteers

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.


Eligibility criteria: 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 exclusion criteria apply

Primary outcomes:
measure: Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Affective Faces Task (AFT) fMRI response
timeFrame: up to 5 weeks
measure: Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Monetary Incentive Delay (MID) fMRI task response
timeFrame: up to 5 weeks
measure: 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
timeFrame: up to 5 weeks
measure: 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
timeFrame: up to 5 weeks
Secondary outcomes:
measure: Change from baseline to 4 week follow-up visit for Eye Tracking
timeFrame: up to 5 weeks
measure: Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Immediate Memory Task (IMT) behavioral test
timeFrame: up to 5 weeks
measure: Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Computerized monetary choice procedure behavioral test
timeFrame: up to 5 weeks
measure: Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Stop-signal paradigm behavioral test
timeFrame: up to 5 weeks
measure: Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Barratt Impulsiveness Scale v.11 (BIS-11)
timeFrame: up to 5 weeks
measure: Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Profile of Mood States behavioral test
timeFrame: up to 5 weeks
measure: Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Go/ No Go task behavioral test
timeFrame: up to 5 weeks
measure: 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
timeFrame: up to 5 weeks
measure: 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
timeFrame: up to 5 weeks
measure: 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
timeFrame: up to 5 weeks
measure: 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
timeFrame: up to 5 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: