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Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment 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

    Secondary endpoints: details revised at 1 of 1 entry; Study description expanded, about 5 words; Publications: details revised at 26 of 26 entries

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: ALL JUVENILE SUBJECTS * Age: 8-17 (subjects who consent as 17-year-olds but turn 18 [...] r subjects who consent as 17-year-olds but do not turn 18). * Consent: can give consent/assent (Parents will provide consent; minors will provide assent) * IQ: all subjects will have IQ\>70 (Assessment relies on either a WASI or assessment by tra [...] vities during the screening visit requires an IQ above 70.) * Language: all subjects will speak English (Tasks in this pro [...] lidated in languages other than English) ALL ADULT SUBJECTS * Age: 18-65 * Consent: can give consent * IQ: all subjects will h [...] [...]
    Show what changed: Study description
    [...] and response to motivational stimuli. Secondary Objectives: * To document relations between baseline neurocognitive featur [...] g Scale (PARS) and Clinical Global Improvement (CGI) Scale. * To document relations between post-treatment changes in neur [...] ment with Cognitive Behavioral Therapy (CBT) or fluoxetine. * To document relations among broad arrays of clinical, cognit [...] (PFC) for each fMRI and MEG paradigm. Secondary Endpoints: * Treatment-response as defined by a continuous measure, the P [...] orial measure, the Clinical Global Improvement (CGI) score. * Levels of symptoms and behaviors evoked by tasks t [...]

  3. Minor

    7 amendments

    7 re-verifications since 2026-07-14, no change to tracked fields

    v398-v404

  4. Minor

    Eligibility criteria expanded, about 12 words

    Show what changed: Eligibility criteria
    [...] use of any psychoactive substance; current suicidal ideation as indicated by the presence of intent for engaging in suicidal behaviors; current diagnosis of attention deficit hyperactivity disor [...]

    Study Status, Eligibilityv397

  5. Minor

    4 amendments

    4 re-verifications since 2026-05-21, no change to tracked fields

    v393-v396

Show 9 earlier versions

  1. Minor

    Eligibility criteria revised

    Show what changed: Eligibility criteria
    [...] pression. Of note, subjects who present with a diagnosis of OCDMDD will not be eligible for inclusion at the outset of the stu [...] y. However, youth with anxiety disorders frequently develop OCDMDD when followed over time. Subjects will be allowed to remain [...]

    Study Status, Eligibilityv392

  2. Minor

    Study sites: 1 to 2

    Collaborators shortened, about 9 words

    Show what changed: Collaborators
    University of Minnesota University of Oregon University of Maryland

    Study Status, Sponsor/Collaborators, Contacts/Locationsv391

  3. Minor

    2 amendments

    2 re-verifications since 2026-04-30, no change to tracked fields

    v389-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; Site contact updated

    Show what changed: Eligibility criteria
    [...] en off of medications to enter the trial.) Current diagnoses Tourette's Disorder, major depressive disorder (MDD); obsessive compulsive disorder (OCD), post-traumatic distress disorder, conduct disorder. (Thes [...] ssion. Of note, subjects who present with a diagnosis of MDD or OCD will not be eligible for inclusion at the outset of the stu [...] y. However, youth with anxiety disorders frequently develop OCD and MDD when followed over time. Subjects will be allowed to rem [...] epression. Of note, subjects who present with a diagnosis of MDD or OCD will not be eligible for inclusion at the outset of the [...] owever, y [...]

    Study Status, Arms and Interventions, Eligibility, Contacts/Locationsv388

  5. Minor

    4 amendments

    4 re-verifications since 2026-03-27, no change to tracked fields

    v384-v387

  1. Minor

    Enrollment increased: 2530 → 3500 participants

    Study Status, Study Designv383

  2. Minor

    Study Status, Study Description

    Re-verified, no change to tracked fields

    v382

  3. Minor

    Eligibility criteria expanded, about 2 words

    Show what changed: Eligibility criteria
    [...] CTS WITH AN ANXIETY DISORDER Diagnosis: Current Diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Diso [...] Y VOLUNTEERS TURNED PATIENTS Diagnosis: Current Diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Diso [...]

    Study Status, Eligibilityv381

  4. Minor

    17 amendments

    17 re-verifications since 2025-05-30, no change to tracked fields

    v364-v380

  5. Minor

    Study description revised

    Show what changed: Study description
    [...] cal features of pediatric anxiety disorders. The study uses neuro-cognitiveneurocognitive tasks, functional magnetic resonance imaging (fMRI), as wel [...]

    Study Status, Study Descriptionv363

  6. Minor

    Eligibility criteria shortened, about 19 words

    Show what changed: Eligibility criteria
    [...] medications to enter the trial.) Current diagnoses Tourette's Disorder, major depressive disorder (MDD); obsessive compu [...] s not exclude participation from follow-up research tasks.) NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy. History of any (excepting nicotine-related and cannabis-rela [...]

    Study Status, Eligibilityv362

  7. Minor

    5 amendments

    5 re-verifications since 2025-04-23, no change to tracked fields

    v357-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 Anxiety Disorders, Major Depressive Disorder
Enrollment 3,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov