Trial Outcomes & Findings for Brain Function and Decision-Making (NCT NCT03974282)

NCT ID: NCT03974282

Last Updated: 2023-02-06

Results Overview

Blood-Oxygen-Level-Dependent signal change in the cognitive empathy brain network will be assessed using functional MRI

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: Baseline to 3 hours
• Results posted on: 2023-02-06

Participant Flow

Participant milestones

Measure	Low Psychopathy Distribution Participants who score at the low end of the psychopathy distribution	High Psychopathy Distribution Participants who score at the high end of the psychopathy distribution
Overall Study STARTED	18	18
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Function and Decision-Making

Baseline characteristics by cohort

Measure	Low Psychopathy Distribution n=18 Participants Participants who score at the low end of the psychopathy distribution	High Psychopathy Distribution n=18 Participants Participants who score at the high end of the psychopathy distribution	Total n=36 Participants Total of all reporting groups
Age, Continuous	20.24 years STANDARD_DEVIATION 2.75 • n=5 Participants	20.59 years STANDARD_DEVIATION 2.12 • n=7 Participants	20.41 years STANDARD_DEVIATION 2.43 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African-American	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Race · Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · White - Hispanic	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Missing Data	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Multiracial	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other Race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · White - Non-Hispanic	2 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	18 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 hours

Blood-Oxygen-Level-Dependent signal change in the cognitive empathy brain network will be assessed using functional MRI

Outcome measures

Measure	Low Psychopathy Distribution n=18 Participants Participants who score at the low end of the psychopathy distribution	High Psychopathy Distribution n=18 Participants Participants who score at the high end of the psychopathy distribution
Change in Prefrontal Cortex Brain Activity Assessed by fMRI	-0.002 Percent BOLD Signal Change Standard Deviation 0.163	0.015 Percent BOLD Signal Change Standard Deviation 0.105

PRIMARY outcome

Timeframe: Baseline to 3 hours

Difference in pain judgment scores rated from 1 (low) to 4 (high) between antisocial vs prosocial empathy trials

Outcome measures

Measure	Low Psychopathy Distribution n=18 Participants Participants who score at the low end of the psychopathy distribution	High Psychopathy Distribution n=18 Participants Participants who score at the high end of the psychopathy distribution
Change in Accuracy of Empathic Pain Judgments	.49 difference in pain scores Standard Deviation .14	.39 difference in pain scores Standard Deviation .14

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Chester

Virginia Commonwealth University

Phone: 8048287624

Email: dschester@vcu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place