NCT03380260

Brief Summary

The primary goal of the present study is to test whether neural activity in brain regions associated with processing threat and social stimuli may underlie paranoid thinking.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1.8 years

First QC Date

December 11, 2017

Last Update Submit

April 26, 2021

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

  • Resting cerebral blood flow (CBF)

    CBF in amygdala and related neural circuits

    CBF measurements will be obtained during the study visit and will last approximately 9 minutes.

Secondary Outcomes (3)

  • Amount of Neural Activity

    Measurements will be obtained during the study visit and will last approximately 25 minutes.

  • Ratings of Trustworthiness

    Data will be obtained during the study visit and will last approximately 12 minutes.

  • Self-reported paranoid ideation

    Data will be obtained during the study visit and will last approximately 5 minutes.

Study Arms (2)

Paranoia Induction

EXPERIMENTAL

Behavioral procedure involving social exclusion and negative feedback to induce paranoia

Behavioral: Paranoia Induction

Control Condition

NO INTERVENTION

No manipulation of paranoid ideation

Interventions

Paranoia InductionBEHAVIORAL

Behavioral procedure involving social exclusion and negative feedback to induce paranoia

Paranoia Induction

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • between the ages of 18 and 55

You may not qualify if:

  • current psychiatric diagnosis
  • current use of psychotropic medications
  • history of head trauma with loss of consciousness for more than 15 minutes
  • presence of neurological or neurodegenerative disorder
  • sensory impairments that preclude assessment
  • presence of intellectual disability
  • contraindications for MRI (e.g., metallic implants or pregnancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Research Imaging Center, The University of Texas Southwestern Medical School

Dallas, Texas, 75390, United States

Location

Study Officials

  • Amy Pinkham, PhD

    The University of Texas at Dallas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 21, 2017

Study Start

June 1, 2017

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)