NCT00029588

Brief Summary

This study will examine and compare brain changes during decision-making in healthy adolescents and adolescents who are anxious or depressed. The findings may provide a better understanding of mechanisms that lead to depression or anxiety. Adolescents between 9 and 17 years of age and adults between 20 and 40 years of age in the following categories will be enrolled in this study:

  • Healthy adults
  • Healthy adolescents
  • Adolescents with major depression
  • Adolescents with anxiety disorder (generalized anxiety disorder, social phobia, or/and separation anxiety disorder) The study involves three visits, as follows: Visit 1 Visit 1 consists of three parts for both child and adult participants:
  • Part 1: Staff will meet with participants for a standard psychiatric interview, which will include questions about the participants feelings, experiences and behavior both past and present. For adolescent participants, staff will meet with the child alone, the parent alone, and the child and parent together.
  • Part 2: Participants will perform a series of simple tasks involving shapes, letters, and numbers. They will have a medical history, physical examination and blood draw. In addition, adolescents will have a urine drug test.
  • Part 3: Adults and those adolescents who will undergo magnetic resonance imaging (MRI) in Visit 3 will receive training to familiarize them with the procedure. Visit 2
  • Adolescents will again be asked standardized questions regarding their feelings, experiences and behavior, and will then perform a series of simple decision-making tasks on a computer.
  • Adults will undergo MRI scanning, as described below in Visit 3 for adolescents. This concludes the participation of adults in the study. Visit 3 Adolescents will have one of the following two procedures: \- Decision-making task using a computer. Small electrodes will be placed on the child s wrists, face and fingers to monitor muscle tone and skin humidity during the task. Or
  • MRI, a test that uses a strong magnetic field and radio waves to show changes in brain function. During the scan, the participant lies on a table in a space enclosed by a metal cylinder (the MRI scanner). The procedure takes 60-90 minutes; subjects must lie still for 10-15 minutes at a time. During imaging, the subject will be asked to perform a decision-making task on a computer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

January 11, 2002

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2002

Completed
15.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2017

Completed
Last Updated

October 6, 2017

Status Verified

July 24, 2017

First QC Date

January 15, 2002

Last Update Submit

October 5, 2017

Conditions

Keywords

fMRIAdolescents and AdultsDepressionAnxietyAnxiety DisorderGADAdolescentsHealthy VolunteerHVNormal Control

Eligibility Criteria

Age9 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age: Subjects will be males and females, 9-17 and 20-40 years of age.

You may not qualify if:

  • Medication status: No history of medication treatment or use of an SSRI \> one month prior to entering the study and fluoxetine \> six months prior to entering the study.
  • Severe acute and chronic medical illnesses
  • CNS disease: History of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological disease, or history of head trauma (defined as loss of consciousness \> 3 min).
  • IQ lower than 70.
  • Metal or electronic objects: Metal plates, certain types of dental braces, cardiac pacemakers, etc., that are sensitive to electromagnetic fields contraindicate MRI scans.
  • Claustrophobia: Subjects will be questioned about potential discomfort in being in an enclosed space, such as an MRI scanner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Childrens National Medical Center

Washington D.C., District of Columbia, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Rogers RD, Owen AM, Middleton HC, Williams EJ, Pickard JD, Sahakian BJ, Robbins TW. Choosing between small, likely rewards and large, unlikely rewards activates inferior and orbital prefrontal cortex. J Neurosci. 1999 Oct 15;19(20):9029-38. doi: 10.1523/JNEUROSCI.19-20-09029.1999.

    PMID: 10516320BACKGROUND
  • Murphy FC, Sahakian BJ, Rubinsztein JS, Michael A, Rogers RD, Robbins TW, Paykel ES. Emotional bias and inhibitory control processes in mania and depression. Psychol Med. 1999 Nov;29(6):1307-21. doi: 10.1017/s0033291799001233.

    PMID: 10616937BACKGROUND
  • Elliott R, Sahakian BJ, McKay AP, Herrod JJ, Robbins TW, Paykel ES. Neuropsychological impairments in unipolar depression: the influence of perceived failure on subsequent performance. Psychol Med. 1996 Sep;26(5):975-89. doi: 10.1017/s0033291700035303.

    PMID: 8878330BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Monique Ernst, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2002

First Posted

January 16, 2002

Study Start

January 11, 2002

Study Completion

July 24, 2017

Last Updated

October 6, 2017

Record last verified: 2017-07-24

Locations