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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00104195
First Posted: February 24, 2005
Last Update Posted: April 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
F. Xavier Castellanos, New York University School of Medicine
  Purpose

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 Phase
Anxiety Disorders Separation Anxiety Disorder Phobic Disorders Phase 1

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Decision-Making Processes and Brain Function in Anxiety-Disordered and Non-Anxious Youth

Resource links provided by NLM:


Further study details as provided by F. Xavier Castellanos, New York University School of Medicine:

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

Enrollment: 127
Study Start Date: February 2004
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Criteria

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
  Contacts and Locations
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


Locations
United States, New York
New York University's Child Study Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
  More Information

Responsible Party: F. Xavier Castellanos, Professor, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00104195     History of Changes
Other Study ID Numbers: H11610
First Submitted: February 23, 2005
First Posted: February 24, 2005
Last Update Posted: April 16, 2014
Last Verified: April 2014

Keywords provided by F. Xavier Castellanos, New York University School of Medicine:
Anxiety
Adolescence
Generalized Anxiety Disorder

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Anxiety, Separation
Mental Disorders
Phobic Disorders
Pathologic Processes
Neurodevelopmental Disorders