Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025857
Status:
COMPLETED
Last Update Posted:
2019-12-03
First Post:
2001-10-26
Brief Title:
Brain Function in Mentally Ill Adolescents
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Adolescent Medial Temporal Lobe Function in Health and Illness
Status:
COMPLETED
Status Verified Date:
2012-06-29
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:
The purpose of this study is to use brain imaging technology to examine the brain activity of adolescents with post-traumatic stress disorder PTSD andor major depressive disorder MDD before and after treatment
Adults with PTSD or MDD exhibit abnormalities in the structure and function of certain parts of the brain Although PTSD and MDD are psychiatric disorders that often emerge in childhood the relationship between these disorders and brain structures has not been thoroughly studied in adolescents with the disorders This study will use functional magnetic resonance imaging fMRI to study the parts of the brain that are involved in PTSD and MDD in adolescents
Adolescents with PTSD andor MDD will be enrolled along with healthy adolescents with or without a history of abuse Healthy adults will also be enrolled Participants will be screened with a physical examination blood tests and interviews about mood general degree of nervousness and behavior Adolescents and their parents will be interviewed separately and together Following the interviews participants will undergo psychological tests Participants with PTSD andor MDD will have two weekly sessions of talk therapy Participants who continue to experience PTSD or MDD symptoms after the talk therapy may continue the talk therapy alone begin treatment with fluoxetine Prozac alone or begin fluoxetine in addition to the talk therapy Participants who take fluoxetine will have blood collected before treatment and 8 weeks after treatment has begun If participants do not respond to the treatment the treatment will be stopped and the participants will be offered another treatment Participants who respond to treatment will continue treatment at NIH until a referral to an outside physician is made Depending on the experiment in which they are enrolled participants will undergo one or four MRI scans Participants who will have four MRI scans will undergo the scans on separate days During the MRI participants will complete tasks on a computer Saliva samples will be collected before and after the scans Participants with PTSD andor MDD will collect their saliva one or two days before the MRI scan
Adults with PTSD or MDD exhibit abnormalities in the structure and function of certain parts of the brain Although PTSD and MDD are psychiatric disorders that often emerge in childhood the relationship between these disorders and brain structures has not been thoroughly studied in adolescents with the disorders This study will use functional magnetic resonance imaging fMRI to study the parts of the brain that are involved in PTSD and MDD in adolescents
Adolescents with PTSD andor MDD will be enrolled along with healthy adolescents with or without a history of abuse Healthy adults will also be enrolled Participants will be screened with a physical examination blood tests and interviews about mood general degree of nervousness and behavior Adolescents and their parents will be interviewed separately and together Following the interviews participants will undergo psychological tests Participants with PTSD andor MDD will have two weekly sessions of talk therapy Participants who continue to experience PTSD or MDD symptoms after the talk therapy may continue the talk therapy alone begin treatment with fluoxetine Prozac alone or begin fluoxetine in addition to the talk therapy Participants who take fluoxetine will have blood collected before treatment and 8 weeks after treatment has begun If participants do not respond to the treatment the treatment will be stopped and the participants will be offered another treatment Participants who respond to treatment will continue treatment at NIH until a referral to an outside physician is made Depending on the experiment in which they are enrolled participants will undergo one or four MRI scans Participants who will have four MRI scans will undergo the scans on separate days During the MRI participants will complete tasks on a computer Saliva samples will be collected before and after the scans Participants with PTSD andor MDD will collect their saliva one or two days before the MRI scan
Detailed Description:
Adults with post-traumatic stress disorder PTSD or major depressive disorder MDD exhibit abnormalities in the structure and function of the amygdala and hippocampus temporal lobe as well as in the prefrontal cortex PFC and striatum four brain structures underlying the emotional processing and reward systems However while these psychiatric disorders often emerge in childhood the integrity of these neural structures has been minimally studied in psychiatrically impaired children and adolescents In the current proposal functional MRI fMRI will be used to evaluate the amygdala hippocampus PFC and striatum in 1 psychiatrically healthy adolescents 2 adolescents with trauma history and PTSD or anxiety symptoms 3 adolescents with trauma history symptoms of depression and either PTSD or anxiety symptoms and 4 adolescents with only major depressive or PTSDanxiety symptoms 5 adolescents with trauma and no trauma related symptoms The proposed study is conducted in three separate experiments
At this stage of the protocol we completed experiment 1 and a pilot study to help guide experiments 2 and 3 In Experiment 1 we determined whether a fear conditioning paradigm elicited amygdala activity in healthy adolescents The pilot study examined test-retest reliability of the fMRI signal in healthy adolescents and adults
In Experiment 2 we will examine the functioning of the amygdala hippocampus PFC and striatum in healthy adolescents and those with the psychiatric conditions described above During image acquisition four cognitive tasks targeting these regions will be used 1 a social interaction task 2 an inhibition task the Stop task or the antisaccade task 3 an emotional ratingexplicit memory task and 4 a probe detection task One hundred twenty five participants 25 in five groups will be recruited in experiment 2
Experiment 3 will address the same question as in experiment 2 in relation to treatment response In other words in contrast to experiment 2 patients will be studied prior and after treatment of the psychopathology associated with their traumatic experience The sample will include 125 patients 25 in each of the 4 groups and 25 controls
At this stage of the protocol we completed experiment 1 and a pilot study to help guide experiments 2 and 3 In Experiment 1 we determined whether a fear conditioning paradigm elicited amygdala activity in healthy adolescents The pilot study examined test-retest reliability of the fMRI signal in healthy adolescents and adults
In Experiment 2 we will examine the functioning of the amygdala hippocampus PFC and striatum in healthy adolescents and those with the psychiatric conditions described above During image acquisition four cognitive tasks targeting these regions will be used 1 a social interaction task 2 an inhibition task the Stop task or the antisaccade task 3 an emotional ratingexplicit memory task and 4 a probe detection task One hundred twenty five participants 25 in five groups will be recruited in experiment 2
Experiment 3 will address the same question as in experiment 2 in relation to treatment response In other words in contrast to experiment 2 patients will be studied prior and after treatment of the psychopathology associated with their traumatic experience The sample will include 125 patients 25 in each of the 4 groups and 25 controls
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-0007 | None | None | None |