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A Research Study of How Teens With and Without an Anxiety Disorder Make Decisions

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ClinicalTrials.gov Identifier: NCT00104195
Recruitment Status : Completed
First Posted : February 24, 2005
Last Update Posted : April 16, 2014
Information provided by (Responsible Party):
F. Xavier Castellanos, NYU Langone Health

Brief Summary:

The purpose of this trial is to study how teens with and without an anxiety disorder make decisions.

This is a brain imaging study using functional magnetic resonance imaging (fMRI) in adolescents between the ages of 13 and 17.

Condition or disease
Anxiety Disorders Separation Anxiety Disorder Phobic Disorders

Detailed Description:
Preliminary analyses of behavioral data showed no group differences in response times during the decision-making games. However, behavioral ratings of certainty during the task showed differences between groups. Anxiety-disordered participants indicated lower levels of certainty during the most uncertain conditions of the task (p < .05). This difference was consistent with the study hypothesis. Within-subjects analyses of the decision-making tasks showed that subjects responded as expected. Reaction times (RT) during uncertain conditions of the HiLo-Game were significantly longer than during more certain conditions (p = .001). Diary Task RTs for rating ambiguous situations were significantly longer than ratings of unambiguous situations (p = .019). Preliminary Analyses showed a significant correlation between Intolerance of Uncertainty (IU) and RT during the Marble Task (r = -0.54, p < .05). Preliminary analysis also showed significant correlation between ratings of level of anxiety during the diary task and IU, IS, MASC and the child version of the SCARED. These preliminary results were not submitted for publication.

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Study Type : Observational
Actual Enrollment : 127 participants
Observational Model: Case-Control
Official Title: Decision-Making Processes and Brain Function in Anxiety-Disordered and Non-Anxious Youth
Study Start Date : February 2004
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Primary Outcome Measures :
  1. Intolerance of Uncertainty [ Time Frame: at time of assessment/enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Anxious and healthy adolescents

Inclusion Criteria:

  • Must meet diagnostic criteria for Generalized Anxiety Disorder, Separation Anxiety Disorder or Social Phobia, OR must be free of medical, psychiatric, neurologic conditions and learning disorders (healthy controls)
  • Sufficient intelligence to understand the study and provide truly informed consent; will be determined by educational history

Exclusion Criteria:

  • Having any major medical conditions that may interfere with interpretation of results or be associated with risk in an MRI environment (history of metal implants, or contraindications to MRI scanning for research purposes, including pregnancy)
  • Current evidence of Autism, Major Depression, Substance Abuse, Obsessive Compulsive Disorder, Post-traumatic Stress Disorder, Panic Disorder, Tic Disorders, significant suicidality, lifetime history of psychosis or mania.
  • Estimated Full-Scale IQ below 80
  • Inability or unwillingness to remain still during scanning
  • Inability or unwillingness to provide assent
  • Absence of signed consent by parent or legal guardian
  • Current history of sexual or physical abuse in the family, or past sexual or physical abuse if there is ongoing Department of Social Services (DSS) involvement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104195

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United States, New York
New York University's Child Study Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
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Responsible Party: F. Xavier Castellanos, Professor, NYU Langone Health
ClinicalTrials.gov Identifier: NCT00104195    
Other Study ID Numbers: H11610
First Posted: February 24, 2005    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014
Keywords provided by F. Xavier Castellanos, NYU Langone Health:
Generalized Anxiety Disorder
Additional relevant MeSH terms:
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Anxiety Disorders
Anxiety, Separation
Phobic Disorders
Pathologic Processes
Mental Disorders
Neurodevelopmental Disorders