NCT00018057

Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders

Recruiting now Phase 2 Last updated 8 April 2026

What this trial tests

Phase 2 trial testing Attention Bias Modification Training in Anxiety Disorders in 3,500 participants. Currently enrolling.

Timeline

2 October 2001

Primary endpoint
1 January 2029

1 January 2029

Quick facts

Lead sponsor	National Institute of Mental Health (NIMH)
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	3,500
Start date	2 October 2001
Primary completion	1 January 2029
Estimated completion	1 January 2029
Sites	1 location across United States

Drugs / interventions tested

• Attention Bias Modification Training
• Fluoxetine (fluoxetine) — full drug profile →

Conditions studied

• Anxiety Disorders — all drugs for Anxiety Disorders →
• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

National Institute of Mental Health (NIMH)

Who can join

Adults 8 to 65, any sex, with Anxiety Disorders or Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 (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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Latent Variable Approach to Differentiating Neural Mechanisms of Irritability and Anxiety in Youth.
   Kircanski K, White LK, Tseng WL, Wiggins JL, et al · · 2018 · cited 97× · PMID 29625429 · DOI 10.1001/jamapsychiatry.2018.0468
2. Brain Mechanisms of Attention Orienting Following Frustration: Associations With Irritability and Age in Youths.
   Tseng WL, Deveney CM, Stoddard J, Kircanski K, et al · · 2019 · cited 86× · PMID 30336704 · DOI 10.1176/appi.ajp.2018.18040491
3. Association of Irritability and Anxiety With the Neural Mechanisms of Implicit Face Emotion Processing in Youths With Psychopathology.
   Stoddard J, Tseng WL, Kim P, Chen G, et al · · 2017 · cited 79× · PMID 27902832 · DOI 10.1001/jamapsychiatry.2016.3282
4. Association between attention bias to threat and anxiety symptoms in children and adolescents.
   Abend R, de Voogd L, Salemink E, Wiers RW, et al · · 2018 · cited 73× · PMID 29212134 · DOI 10.1002/da.22706
5. Complementary Features of Attention Bias Modification Therapy and Cognitive-Behavioral Therapy in Pediatric Anxiety Disorders.
   White LK, Sequeira S, Britton JC, Brotman MA, et al · · 2017 · cited 71× · PMID 28407726 · DOI 10.1176/appi.ajp.2017.16070847
6. Anticipatory Threat Responding: Associations With Anxiety, Development, and Brain Structure.
   Abend R, Gold AL, Britton JC, Michalska KJ, et al · · 2020 · cited 58× · PMID 31955915 · DOI 10.1016/j.biopsych.2019.11.006
7. The Coronavirus Impact Scale: Construction, Validation, and Comparisons in Diverse Clinical Samples.
   Stoddard J, Reynolds E, Paris R, Haller SP, et al · · 2023 · cited 54× · PMID 37359142 · DOI 10.1016/j.jaacop.2023.03.003
8. Neural changes with attention bias modification for anxiety: a randomized trial.
   Britton JC, Suway JG, Clementi MA, Fox NA, et al · · 2015 · cited 52× · PMID 25344944 · DOI 10.1093/scan/nsu141