fMRI in Impulsivity

Completed

• Conditions: Impulse Control Disorders; Borderline Personality Disorder

• Registration Number: NCT02755181
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-08
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-28
• Study Start: 2016-07-22
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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
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
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 Outcome Measures

Name	Time	Method
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
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
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
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
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
Change from baseline to 4 week follow-up visit for Eye Tracking	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)	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	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	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	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	up to 5 weeks

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States