- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03380260
Investigating Neural Processing of Social Stimuli
Investigating Neural Processing of Social Stimuli: Investigating a Neurobehavioral Mechanism of Paranoia
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- Advanced Research Imaging Center, The University of Texas Southwestern Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Paranoia Induction
Behavioral procedure involving social exclusion and negative feedback to induce paranoia
|
Behavioral procedure involving social exclusion and negative feedback to induce paranoia
|
NO_INTERVENTION: Control Condition
No manipulation of paranoid ideation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting cerebral blood flow (CBF)
Time Frame: CBF measurements will be obtained during the study visit and will last approximately 9 minutes.
|
CBF in amygdala and related neural circuits
|
CBF measurements will be obtained during the study visit and will last approximately 9 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of Neural Activity
Time Frame: Measurements will be obtained during the study visit and will last approximately 25 minutes.
|
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.
|
Ratings of Trustworthiness
Time Frame: Data will be obtained during the study visit and will last approximately 12 minutes.
|
Behavioral perceptions of the trustworthiness of others
|
Data will be obtained during the study visit and will last approximately 12 minutes.
|
Self-reported paranoid ideation
Time Frame: Data will be obtained during the study visit and will last approximately 5 minutes.
|
Data will be obtained during the study visit and will last approximately 5 minutes.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17-44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Adults
-
KU LeuvenCompletedHealthy Older Adults | Ill Older AdultsBelgium
-
Samsung Medical CenterTerminatedHealthy Aging | Healthy AdultsKorea, Republic of
-
King Abdulaziz UniversityUniversity College Dublin; Royal College of Surgeons, IrelandRecruitingHealthy Adults | Healthy NutritionSaudi Arabia
-
Lumos Labs, Inc.Not yet recruitingHealthy AdultsUnited States
-
Shirley Ryan AbilityLabNot yet recruiting
-
National Institute of Allergy and Infectious Diseases...RecruitingHealthy AdultsUnited States
-
Arizona State UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingHealthy AdultsUnited States
-
Marian NeuhouserDuke University; University of Washington; University of Nebraska; United States...Recruiting
-
Mirati Therapeutics Inc.CompletedHealthy AdultsUnited States
-
Ohio State UniversityActive, not recruitingHealthy AdultsUnited States
Clinical Trials on Paranoia Induction
-
Weill Medical College of Cornell UniversityNational Alliance for Research on Schizophrenia and DepressionCompleted
-
Northwell HealthBoston University; University of Pittsburgh; Dartmouth-Hitchcock Medical CenterCompletedSchizophrenia | Schizoaffective Disorder | Psychosis NOSUnited States
-
University of ValenciaCompletedHappiness | SadnessSpain
-
Centre Hospitalier Universitaire, AmiensUniversité de LilleCompletedChronic Pain | Fibromyalgia | Rumination | Repetitive Negative ThinkingFrance
-
Universidad de LeónCompletedFoot Diseases | Myofascial PainSpain
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedEndothelial Dysfunction | EmotionsUnited States
-
Foundation University IslamabadRecruitingHypertrophic ScarPakistan
-
University of DenverWake Forest UniversityCompleted
-
Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedAngioplasty PatientsUnited States