Protocol Number: 02-M-0092

Title:

Reward-Related Processes and Brain Function

Number:

02-M-0092

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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

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

Psychiatric history: Subjects in Group 3, and 4 will be diagnosed with current MD, and current AD (generalized anxiety disorder, social phobia, or/and separation anxiety disorder) respectively, based on k-SADS interviews of parents and adolescents for minors (less than 18 years old), and SCID for adults. History of anxiety disorders in individuals with MD is acceptable, if current symptoms are mild or absent. Similarly, history of depression in individuals with AD is acceptable, if current symptoms are mild or absent. AD and MD patients should have a CGAS of less than 70.

Medication status: No history of medication treatment or use of an SSRI greater than one month prior to entering the study and fluoxetine greater than six months prior to entering the study.

EXCLUSION CRITERIA:

Because factors such as psychiatric disease, or CNS disease, can influence functional brain activity, and pregnancy precludes participation in fMRI studies, these factors are exclusionary.

Psychiatric disease: Any current history of an axis I diagnosis other than adjustment disorder, simple phobia, Social Phobia, Separation Anxiety, dysthymia, GAD and MD is exclusionary. Subjects will be assessed using DSM-IV criteria via standardized psychiatric interviews conducted by trained examiners (K-SADS in minors and SCID in adults). Any current suicidal ideation, and severe ADHD requiring pharmacotherapy will be exclusionary.

History of Drug Abuse: Axis I diagnosis of substance use disorders will be exclusionary.

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 greater than 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.

Pregnancy status. Sexually mature female participants must have a negative serum pregnancy test performed within 24 hours of the fMRI scan.

Special Instructions: Currently Not Provided

Keywords:

Depression

Emotional Context

Decision-Making

Affective Neuroscience

Neuroimaging

Adolescents and Adults

Recruitment Keywords:

Depression

Anxiety

Anxiety Disorder

GAD

Adolescents

Healthy Volunteer

HV

Normal Control

Conditions:

Depression

Anxiety Disorders

Healthy

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Rogers RD, et al Choosing between small, likel[PMID:10516320]

Murphy FC, et al Emotional bias and inhibitory[PMID:10616937]

Elliott R, et al Neuropsychological impairment[PMID:8878330]

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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