- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05092971
Identifying Decision Making Parameters in Healthy Volunteers and Anxiety Patients
Identifying Decision Making Parameters in Healthy Volunteers (HV) and Anxiety Patients (AD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Description:
This study s goal is to identify parameters of interest in decision making in the context of anxiety disorders, using theoretical models in healthy volunteers (HV) and anxiety patients (AD). Participants are asked to complete a decision-making task, namely the Multi-armed Bandit Task.
The study will be conducted in the clinic. Participants (HV and AD) are asked to fill out questionnaires and complete the Multi-armed Bandit Task. An electric shock is used as the aversive stimulus. Monetary reward is used as the reward stimulus. Additionally, physiological signals (Heart rate, skin conductance activity, startle) are collected during the course of the task. In addition, in a pilot study, participants startle responses for varying shock parameters are recorded and analyzed.
Objectives:
The primary objective of this study is to use theoretical models in healthy volunteers (HV) and patients with an anxiety disorder (AD) to better understand how changes in anxiety are associated with changes in decision making. In addition, this study will ascertain whether decision making parameters correlate with certain behavioral measures such as trait and state anxiety using (i) questionnaires, (ii) physiological measures.
Endpoints:
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups. The parameters of interest include: 1) Learning Rate, 2) Exploration parameter, 3) Discount rate, 4) Loss aversion, 5) Inverse Temperature.
The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:
- Questionnaire scores
- Startle
- Skin conductance
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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 DSM5 diagnoses of an anxiety disorder (GAD, 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 NIMH or an immediate family member of a NIMH employee.
- Healthy volunteers only: Current DSM-5 disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Clinic
Tasks to be completed in OP4 clinic
|
Part 1 to be completed in the clinic.
Subject participation is for one part and is pseudo-randomly.
|
Other: fMRI
Tasks to be completed in fMRI
|
Part 2 to be completed in the scanner.
Subject participation is for one part and is pseudo-randomly.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Learning rate
Time Frame: End of study
|
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
|
End of study
|
Risk-taking (vs. risk aversion)
Time Frame: End of study
|
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
|
End of study
|
Discount rate
Time Frame: End of study
|
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
|
End of study
|
Inverse temperature
Time Frame: End of study
|
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
|
End of study
|
Loss aversion
Time Frame: End of study
|
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
|
End of study
|
Exploration parameter
Time Frame: End of study
|
The primary endpoint of this study is a significant difference in model derived parameters between experimental manipulations (conditions) and/or population groups.
|
End of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Startle
Time Frame: End of study
|
The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:
|
End of study
|
STAI questionnaire
Time Frame: End of study
|
The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:
|
End of study
|
Skin conductance
Time Frame: End of study
|
The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:
|
End of study
|
MASQ
Time Frame: End of study
|
The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:
|
End of study
|
BIS/BAS
Time Frame: End of study
|
The secondary endpoints are a significant correlation between functions of model derived parameters and behavioral and/or physiological measures of anxiety including:
|
End of study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Monique Ernst, M.D., National Institute of Mental Health (NIMH)
Publications and helpful links
Helpful Links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10000378
- 000378-M
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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 Anxiety
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)Active, not recruitingGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Dr. Nazanin AlaviActive, not recruitingGeneralized Anxiety Disorder | AnxietyCanada
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States
Clinical Trials on Multi-arm bandit tasks
-
National Cheng Kung UniversityCompletedDementia | Aging | Cognitive Training | Occupational Therapy | Long Term CareTaiwan
-
University of Wisconsin, MadisonNational Institute for Biomedical Imaging and Bioengineering (NIBIB)Not yet recruiting
-
Qatar UniversityHamad Medical Corporation; Weill Cornell Medical College in Qatar; University... and other collaboratorsCompleted
-
The Cleveland ClinicCompletedOveractive Bladder | Urge Incontinence | Urinary Incontinence, Urge | Overactive Bladder SyndromeUnited States
-
AIO-Studien-gGmbHServier; Institut für Klinisch-Onkologische Forschung der Krankenhaus Nordwest...Active, not recruitingBiliary Tract Cancer | Extrahepatic Bile Duct Carcinoma | Non-Resectable Hepatocellular Carcinoma | Adenocarcinoma Metastatic | Adenocarcinoma of the Biliary Tract | Adenocarinoma Locally Advanced | Intrahepatic Bile Duct CarcinomaGermany
-
National Institute of Neurological Disorders and...CompletedParkinson's Disease | Movement Disorders | Dystonia | Tic Disorders | Tourette's SyndromeUnited States
-
Children's Oncology GroupRecruitingAcute Myeloid Leukemia | Acute Lymphoblastic Leukemia | Myelodysplastic Syndrome | Mixed Phenotype Acute LeukemiaUnited States, Australia, Canada
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityTerminatedPrimary Myelofibrosis | Anemia | Recurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Anatomic Stage IV Breast Cancer AJCC v8 | Recurrent Acute Myeloid Leukemia | Recurrent Myelodysplastic Syndrome | Refractory Acute Myeloid Leukemia | Refractory Chronic Myelomonocytic Leukemia | Refractory Myelodysplastic... and other conditionsUnited States