Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00018057
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2001-06-29
Brief Title:
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Status:
RECRUITING
Status Verified Date:
2024-09-25
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:
Study Description
This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders The study uses neuro-cognitive tasks functional magnetic resonance imaging fMRI as well as magneto- and electro-encephalography MEEG Patients will be studied over one year before and after receiving either one of two standard-of-care treatments cognitive behavioral therapy CBT or fluoxetine a serotonin reuptake inhibitor SSRI Healthy comparisons will be studied at comparable time points
Primary Objectives
To compare healthy youth and symptomatic medication-free pediatric patients studied prior to receipt of treatment The study seeks to detect relations between clinical features of anxiety disorders at baseline and a wide range of neurocognitive features associated with attention memory and response to motivational stimuli
Secondary Objectives
1 To document relations between baseline neurocognitive features and response to Cognitive Behavioral Therapy CBT or fluoxetine as defined by the Pediatric Anxiety Rating Scale PARS and Clinical Global Improvement CGI Scale
2 To document relations between post-treatment changes in neurocognitive features and anxiety symptoms on the PARS following treatment with Cognitive Behavioral Therapy CBT or fluoxetine
3 To document relations among broad arrays of clinical cognitive and neural measures
Primary Endpoints
Indices of percent-signal change in hypothesized brain regions comprising amygdala striatum and prefrontal cortex PFC for each fMRI and MEG paradigm
Secondary Endpoints
1 Treatment-response as defined by a continuous measure the Pediatric Anxiety Rating Scale score PARS and a categorial measure the Clinical Global Improvement CGI score
2 Levels of symptoms and behaviors evoked by tasks that engage attention memory and elicit responses to motivational stimuli
This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders The study uses neuro-cognitive tasks functional magnetic resonance imaging fMRI as well as magneto- and electro-encephalography MEEG Patients will be studied over one year before and after receiving either one of two standard-of-care treatments cognitive behavioral therapy CBT or fluoxetine a serotonin reuptake inhibitor SSRI Healthy comparisons will be studied at comparable time points
Primary Objectives
To compare healthy youth and symptomatic medication-free pediatric patients studied prior to receipt of treatment The study seeks to detect relations between clinical features of anxiety disorders at baseline and a wide range of neurocognitive features associated with attention memory and response to motivational stimuli
Secondary Objectives
1 To document relations between baseline neurocognitive features and response to Cognitive Behavioral Therapy CBT or fluoxetine as defined by the Pediatric Anxiety Rating Scale PARS and Clinical Global Improvement CGI Scale
2 To document relations between post-treatment changes in neurocognitive features and anxiety symptoms on the PARS following treatment with Cognitive Behavioral Therapy CBT or fluoxetine
3 To document relations among broad arrays of clinical cognitive and neural measures
Primary Endpoints
Indices of percent-signal change in hypothesized brain regions comprising amygdala striatum and prefrontal cortex PFC for each fMRI and MEG paradigm
Secondary Endpoints
1 Treatment-response as defined by a continuous measure the Pediatric Anxiety Rating Scale score PARS and a categorial measure the Clinical Global Improvement CGI score
2 Levels of symptoms and behaviors evoked by tasks that engage attention memory and elicit responses to motivational stimuli
Detailed Description:
Study Description
This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders The study uses neuro-cognitive tasks functional magnetic resonance imaging fMRI as well as magneto- and electro-encephalography MEEG Patients will be studied over one year before and after receiving either one of two standard-of-care treatments cognitive behavioral therapy CBT or fluoxetine a serotonin reuptake inhibitor SSRI Healthy comparisons will be studied at comparable time points
Primary Objectives
-To compare healthy youth and symptomatic medication-free pediatric patients studied prior to receipt of treatment The study seeks to detect relations between clinical features of anxiety disorders at baseline and a wide range of neurocognitive features associated with attention memory and response to motivational stimuli
Secondary Objectives
To document relations between baseline neurocognitive features and response to Cognitive Behavioral Therapy CBT or fluoxetine as defined by the Pediatric Anxiety Rating Scale PARS and Clinical Global Improvement CGI Scale
To document relations between post-treatment changes in neurocognitive features and anxiety symptoms on the PARS following treatment with Cognitive Behavioral Therapy CBT or fluoxetine
To document relations among broad arrays of clinical cognitive and neural measures
Primary Endpoints
-Indices of percent-signal change in hypothesized brain regions comprising amygdala striatum and prefrontal cortex PFC for each fMRI and MEG paradigm
Secondary Endpoints
Treatment-response as defined by a continuous measure the Pediatric Anxiety Rating Scale score PARS and a categorial measure the Clinical Global Improvement CGI score
Levels of symptoms and behaviors evoked by tasks that engage attention memory and elicit responses to motivational stimuli
This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders The study uses neuro-cognitive tasks functional magnetic resonance imaging fMRI as well as magneto- and electro-encephalography MEEG Patients will be studied over one year before and after receiving either one of two standard-of-care treatments cognitive behavioral therapy CBT or fluoxetine a serotonin reuptake inhibitor SSRI Healthy comparisons will be studied at comparable time points
Primary Objectives
-To compare healthy youth and symptomatic medication-free pediatric patients studied prior to receipt of treatment The study seeks to detect relations between clinical features of anxiety disorders at baseline and a wide range of neurocognitive features associated with attention memory and response to motivational stimuli
Secondary Objectives
To document relations between baseline neurocognitive features and response to Cognitive Behavioral Therapy CBT or fluoxetine as defined by the Pediatric Anxiety Rating Scale PARS and Clinical Global Improvement CGI Scale
To document relations between post-treatment changes in neurocognitive features and anxiety symptoms on the PARS following treatment with Cognitive Behavioral Therapy CBT or fluoxetine
To document relations among broad arrays of clinical cognitive and neural measures
Primary Endpoints
-Indices of percent-signal change in hypothesized brain regions comprising amygdala striatum and prefrontal cortex PFC for each fMRI and MEG paradigm
Secondary Endpoints
Treatment-response as defined by a continuous measure the Pediatric Anxiety Rating Scale score PARS and a categorial measure the Clinical Global Improvement CGI score
Levels of symptoms and behaviors evoked by tasks that engage attention memory and elicit responses to motivational stimuli
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 01-M-0192 | None | None | None |