Actively Recruiting
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Led by National Institute of Mental Health (NIMH) · Updated on 2026-05-12
3500
Participants Needed
2
Research Sites
1421 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 (M/EEG). 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.
CONDITIONS
Official Title
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 8 to 17 years (with consent/assent) or 18 to 65 years (with consent)
- IQ greater than 70 as assessed by WASI or clinical staff
- English speaking
- Current diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder for anxiety patients
- Clinically significant ongoing anxiety symptoms and impairment documented by clinician review
- Healthy volunteers may have no current anxiety diagnosis
You will not qualify if you...
- Serious medical condition interfering with brain imaging or increasing SSRI treatment risk
- Pregnancy (excluded from MRI portions)
- Current use of psychoactive substances or suicidal ideation
- Current ADHD requiring medication
- Current diagnosis of major depressive disorder, post-traumatic stress disorder, conduct disorder (not eligible at outset)
- History of mania, psychosis, or severe pervasive developmental disorder
- Recent SSRI treatment failure at adequate dose and duration
- History of moderate to severe substance use disorder (except nicotine or cannabis)
- Healthy adult subjects with any current psychiatric diagnosis
AI-Screening
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Trial Site Locations
Total: 2 locations
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
2
University of Maryland, College Park
College Park, Maryland, United States, 20742
Actively Recruiting
Research Team
D
Daniel S Pine, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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