Healthy AdultsNCT03380260
Investigating Neural Processing of Social Stimuli
A study testing Paranoia Induction in people with Healthy Adults, run by The University of Texas at Dallas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Paranoia Induction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between the ages of 18 and 55
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Research Imaging Center, The University of Texas Southwestern Medical School
Dallas, Texas, 75390
About this study
Official title: Investigating Neural Processing of Social Stimuli: Investigating a Neurobehavioral Mechanism of Paranoia
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.
Read the 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.
- Conditions
- Healthy Adults
- Being tested
- Paranoia Induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paranoia InductionBehavioural
Behavioral procedure involving social exclusion and negative feedback to induce paranoia
| Study group | Role | What they receive |
|---|---|---|
| Paranoia Induction | Experimental | Behavioral procedure involving social exclusion and negative feedback to induce paranoia Receives: Behavioral: Paranoia Induction |
| Control Condition | No intervention | No manipulation of paranoid ideation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting cerebral blood flow (CBF)
CBF in amygdala and related neural circuits
Measured: CBF measurements will be obtained during the study visit and will last approximately 9 minutes.
Secondary outcomes (3)
Amount of Neural Activity
Task-related activation of amygdala and related neural circuits measured with blood-oxygenation-level-dependent imaging
Measured: Measurements will be obtained during the study visit and will last approximately 25 minutes.
Ratings of Trustworthiness
Behavioral perceptions of the trustworthiness of others
Measured: Data will be obtained during the study visit and will last approximately 12 minutes.
Self-reported paranoid ideation
Measured: Data will be obtained during the study visit and will last approximately 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start1 Jun 2017
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Pinkham, The University of Texas at Dallas
- Investigators
- Amy Pinkham, PhD, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380260
- Sponsor's protocol ID
- 17-44
- Status last verified
- Apr 2021
- First submitted
- 11 Dec 2017
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Neural Processing of Social Stimuli: Investigating a Neurobehavioral Mechanism of Paranoia
- ClinicalTrials.gov ID
- NCT03380260
- Acronym / sponsor ID
- 17-44
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paranoia Induction | Experimental | Behavioral: Paranoia InductionBehavioral procedure involving social exclusion and negative feedback to induce paranoia |
| Control Condition | No intervention | –No manipulation of paranoid ideation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- between the ages of 18 and 55
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paranoia InductionBehavioral procedure involving social exclusion and negative feedback to induce paranoia | Behavioural | Paranoia Induction |
Primary outcome
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
3 secondary outcomes
Amount of Neural Activity
Time frame: 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.
Self-reported paranoid ideation
Time frame: Data will be obtained during the study visit and will last approximately 5 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Pinkham, PhD principal investigator
The University of Texas at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paranoia Induction in people with Healthy Adults, run by The University of Texas at Dallas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting cerebral blood flow (CBF) (time frame: CBF measurements will be obtained during the study visit and will last approximately 9 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.