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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03380260
Other study ID # 17-44
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date April 1, 2019

Study information

Verified date April 2021
Source The University of Texas at Dallas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Paranoia is a prominent symptom of psychosis that occurs in several other diagnoses, as well as the general population, and that is associated with significant distress and impairment. Previous research suggests that increased baseline activity of the amygdala and related neural circuits may serve as a mechanism for paranoid ideation. This exploratory study will use a paranoia induction procedure in healthy individuals who vary in pre-existing levels of paranoid ideation to test whether increases in self-reported paranoia are accompanied by increases in resting cerebral blood flow (CBF), decreased stimulus-driven neural activity in social processing networks, and increased behavioral perceptions of untrustworthiness. Participants will be randomly assigned to participate in a paranoia induction procedure or a control condition and will then complete neuroimaging and behavioral assessments.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - between the ages of 18 and 55 Exclusion Criteria: - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Paranoia Induction
Behavioral procedure involving social exclusion and negative feedback to induce paranoia

Locations

Country Name City State
United States Advanced Research Imaging Center, The University of Texas Southwestern Medical School Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas at Dallas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Amount of Neural Activity Task-related activation of amygdala and related neural circuits measured with blood-oxygenation-level-dependent imaging Measurements will be obtained during the study visit and will last approximately 25 minutes.
Secondary Ratings of Trustworthiness Behavioral perceptions of the trustworthiness of others Data will be obtained during the study visit and will last approximately 12 minutes.
Secondary Self-reported paranoid ideation Data will be obtained during the study visit and will last approximately 5 minutes.
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