Actively Recruiting

Phase 2
Age: 8Years - 65Years
All Genders
Healthy Volunteers
NCT00018057

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

Age: 8Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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