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Trial record 1 of 1 for:    NCT02755181
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fMRI in Impulsivity

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02755181
First received: April 8, 2016
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Impulse Control Disorders
Borderline Personality Disorder
Behavioral: Experimental

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Longitudinal Functional Magnetic Resonance Imaging (fMRI) as a Brain Measure for Impulsivity in a Borderline Personality Disorder (BPD) Model

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 Outcome Measures:
  • Change from baseline to 4 week follow-up visit for Eye Tracking [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: up to 5 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Estimated Enrollment: 60
Actual Study Start Date: July 22, 2016
Estimated Study Completion Date: July 13, 2018
Estimated Primary Completion Date: July 13, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BPD
Borderline Personality Disorder as diagnosed by DSM-5
Behavioral: Experimental
with functional imaging and behavioural measurements at baseline and 4 weeks
normal volunteers
normal volunteers
Behavioral: Experimental
with functional imaging and behavioural measurements at baseline and 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
BPD and normal volunteers
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-V 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 cannabis, cocaine, opiates, 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:

  • Current or past DSM-V Axis II diagnoses of Cluster B Personality disorders
  • Current or past DSM-V Axis I diagnoses based on the SCID (including the eating disorders module)
  • History of arrest or incarceration

In addition, Borderline Personality Disorder Subjects excluded if:

  • Current DSM-V Axis I diagnoses
  • Current DSM-V Axis II diagnoses other than Cluster B personality disorders
  • Current psychoactive medications
  • Further exclusion criteria apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02755181

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02755181     History of Changes
Other Study ID Numbers: 352.2067
Study First Received: April 8, 2016
Last Updated: April 19, 2017

Additional relevant MeSH terms:
Disease
Personality Disorders
Borderline Personality Disorder
Impulsive Behavior
Disruptive, Impulse Control, and Conduct Disorders
Pathologic Processes
Mental Disorders

ClinicalTrials.gov processed this record on April 28, 2017