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Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 406 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fields
  2. Minor Eligibility criteria expanded, about 22 words
    • Study description expanded, about 5 words
  3. Minor 7 versions Re-verified since Jul 14, 2026, no change to tracked fieldsv398-v404
  4. Minor Eligibility criteria expanded, about 12 wordsv397
  5. Minor 4 versions Re-verified since May 21, 2026, no change to tracked fieldsv393-v396
Show 9 earlier versionsHide 9 earlier versions
  1. Minor Eligibility criteria revisedv392
  2. Minor Study sites: 1 to 2v391
  3. Minor 2 versions Re-verified since Apr 30, 2026, no change to tracked fieldsv389-v390
  4. Minor Interventions: Attention Bias Modification Training (Behavioral), Fluoxetine (Drug) to Attention Bias Modification Training (Behavioral), Cognitive Behavioral Therapy (Behavioral), Fluoxetine (Drug)
    • Eligibility criteria shortened, about 14 words
    v388
  5. Minor 4 versions Re-verified since Mar 27, 2026, no change to tracked fieldsv384-v387
  1. Minor Enrollment increased: 2530 → 3500 participantsv383
  2. Minor Re-verified, no change to tracked fieldsv382
  3. Minor Eligibility criteria expanded, about 2 wordsv381
  4. Minor 17 versions Re-verified since May 30, 2025, no change to tracked fieldsv364-v380
  5. Minor Study Status, Study Descriptionv363
  6. Minor Study Status, Eligibilityv362
  7. Minor 5 versions Re-verified since Apr 23, 2025, no change to tracked fieldsv357-v361
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00018057
Lead Sponsor National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
Anxiety Disorders, Major Depressive Disorder
Related terms Anxiety Disorders, Major Depressive Disorder
Enrollment 3,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov