N/A
N=51
Identifying Decision Making Parameters in Healthy Volunteers and Anxiety Patients
Anxiety · Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT05092971 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Difference in Learning Rate — 0.009; 0.0058 unitless
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Shock or startle device (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Mental Health (NIMH)
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Learning Rate |
0.009; 0.0058 | — |
Summary
Background:
Research has shown that anxiety affects more than feelings. It also affects behavior. Researchers want to learn how the brain and body respond to unexpected threats. They want to see if probable pleasant or unpleasant events change decisions.
Objective:
To better understand how changes in anxiety are associated with changes in decision-making.
Eligibility:
Adults aged 18-50 with generalized anxiety disorder, seasonal affective disorder, or panic disorder. Healthy volunteers are also needed.
Design:
Participants will be screened under protocol #01-M-0254.
Participants will complete surveys about their anxiety, risk-taking, and curiosity.
Participants will complete a computer task. They will be given different choices. They will make a choice. They will receive an unpleasant or pleasant stimulus based on their choice. They will repeat this task many times.
Most participants will do the task in the clinic. The unpleasant stimulus will be electric shock and acoustic startle. They will receive electric shocks through electrodes placed on their arm or fingers. They may hear loud noises through headphones. Their eyeblinks will be recorded with electrodes placed under their eye. Their heart rate and skin conductance activity will be collected with electrodes as well.
Some healthy volunteers will do the task during a functional magnetic resonance imaging scan. They will lie on a table that slides in and out of a scanner. A coil will be placed over their head. The unpleasant stimulus will be electric shock, given as stated above. The scanner will record their brain activity. Their breathing and pulse rate will be recorded as well.
Participation will last for 3-4 hours.
Eligibility Criteria
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Male or female, aged 18-50, inclusive
- Patients only: Primary Diagnostic and Statistical Manual (DSM) 5 diagnoses of an anxiety disorder (GAD, social anxiety disorder (SAD), panic disorder)
EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
- Non-English speaking individual
- Pregnancy or positive pregnancy test
- Any significant medical or neurological problems as determined by investigators (e.g.cardiovascular illness, respiratory illness, neurological illness, seizure, etc.)
- Current or past serious mental disorders (e.g., bipolar or psychotic disorders) (except for anxiety and depressive disorders in patients)
- Current alcohol or substance use disorder
- History of moderate or severe alcohol or substance use disorder within one year prior to screening
- Current or past significant organic central nervous system disorders as determined by investigators, including but not limited to seizure disorder or neurological symptoms of the wrist and arm (e.g., carpal tunnel syndrome) for shocks to be delivered on affected arm.
- Positive urine toxicology screen at screening visit under 01-M-0254
- Employees of National Institute of Mental Health (NIMH) or an immediate family member of a NIMH employee.
- Healthy volunteers only: Current DSM-5 disorders.
Data sourced from ClinicalTrials.gov (NCT05092971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.