fMRI in Impulsivity

Borderline Personality Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755181
• Other study ID #: 352.2067
• Status: Completed
• Start date: July 22, 2016
• Est. completion date: May 30, 2018

Study information

• Verified date: August 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Disease
• Impulse Control Disorders
• Impulsive Behavior
• Personality Disorders

Intervention

Behavioral:
• Experimental
with functional imaging and behavioural measurements at baseline and 4 weeks

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change from baseline to 4 week follow-up visit for Eye Tracking		up to 5 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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