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

Anxiety Disorders Clinical Trial

Official title:

Decision-Making Processes and Brain Function in Anxiety-Disordered and Non-Anxious Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104195
• Other study ID #: H11610
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2005
• Last updated: April 15, 2014
• Start date: February 2004
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Separation
• Disease
• Mental Disorders
• Phobic Disorders
• Separation Anxiety Disorder

Locations

Country	Name	City	State
United States	New York University's Child Study Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intolerance of Uncertainty		at time of assessment/enrollment	No