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Completed

NCT Number: NCT02755181

fMRI in Impulsivity

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental

Behavioral

with functional imaging and behavioural measurements at baseline and 4 weeks

Primary outcomes

  1. Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Affective Faces Task (AFT) fMRI response

    Time frame: up to 5 weeks

  2. Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Monetary Incentive Delay (MID) fMRI task response

    Time frame: up to 5 weeks

  3. 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

    Time frame: up to 5 weeks

  4. 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

    Time frame: up to 5 weeks

Secondary outcomes

  1. Change from baseline to 4 week follow-up visit for Eye Tracking

    Time frame: up to 5 weeks

  2. Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Immediate Memory Task (IMT) behavioral test

    Time frame: up to 5 weeks

  3. Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Computerized monetary choice procedure behavioral test

    Time frame: up to 5 weeks

  4. Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Stop-signal paradigm behavioral test

    Time frame: up to 5 weeks

  5. Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Barratt Impulsiveness Scale v.11 (BIS-11)

    Time frame: up to 5 weeks

  6. Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Profile of Mood States behavioral test

    Time frame: up to 5 weeks

  7. Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Go/ No Go task behavioral test

    Time frame: up to 5 weeks

  8. 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

    Time frame: up to 5 weeks

  9. 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

    Time frame: up to 5 weeks

  10. 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

    Time frame: up to 5 weeks

  11. 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

    Time frame: up to 5 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Assessment of Longitudinal Functional Magnetic Resonance Imaging (fMRI) as a Brain Measure for Impulsivity in a Borderline Personality Disorder (BPD) Model

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 28, 2016
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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