Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029588
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2002-01-15
Brief Title:
Reward-Related Processes and Brain Function
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Reward-Related Processes and Brain Function
Status:
COMPLETED
Status Verified Date:
2017-07-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 orand 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
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 orand 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
Detailed Description:
Impaired motivated behaviors including aspects of decision-making and reward-related processes lie at the root of maladaptive behavior in many psychiatric disorders including major depression MD Little is known of the cognitive and neural mechanisms that underlie MD in adolescents Adolescence is a key period during which many psychiatric disorders first emerge and studies during this developmental stage may provide a unique window to address primary deficits associated with the disorders In particular major depression shows a marked increase in prevalence at adolescence Data from family-based and longitudinal studies suggest that anxiety disorders AD often preceding MD may index childhood vulnerabilities for the development of MD The concomitant examination of MD and AD can help interpret these findings We propose to examine in adolescents the manner in which the various elemental emotional-cognitive processes are differentially affected in MD and AD compared to healthy controls This investigation will be done in two phases In Phase I using fMRI we will test two tasks in the decision-making model of gambling that have similarly been tested in adults in a group of healthy adolescents and healthy adults This phase will serve as a test of the feasibility and validity of using these tasks in adolescents and will provide normative developmental data by comparing healthy adults with healthy adolescents In addition to showing the feasibility of using these tasks in normal adolescents we will also test task performance behaviorally in healthy anxious and depressed adolescents Measures will include psychophysiological and eye tracking measures and behavioral variables Once task performance is well characterized behaviorally we will conduct in Phase II an fMRI study in independent groups of depressed and anxious adolescents and compare the findings with those obtained in healthy adolescents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-M-0092 | None | None | None |