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fMRI in Impulsivity

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ClinicalTrials.gov Identifier: NCT02755181
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment
Impulse Control Disorders Borderline Personality Disorder Behavioral: Experimental

Study Type : Observational
Actual Enrollment : 48 participants
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
Actual Study Start Date : July 22, 2016
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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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-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755181


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02755181     History of Changes
Other Study ID Numbers: 352.2067
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

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