NCT00104195

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2005

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 16, 2014

Status Verified

April 1, 2014

Enrollment Period

10.2 years

First QC Date

February 23, 2005

Last Update Submit

April 15, 2014

Conditions

Keywords

AnxietyAdolescenceGeneralized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • Intolerance of Uncertainty

    at time of assessment/enrollment

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Anxious and healthy adolescents

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University's Child Study Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Anxiety DisordersAnxiety, SeparationPhobic DisordersGeneralized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental DisordersNeurodevelopmental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 23, 2005

First Posted

February 24, 2005

Study Start

February 1, 2004

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 16, 2014

Record last verified: 2014-04

Locations