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NCT00018057 · ClinicalTrials.gov registry record · Phase 2

Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders

A Phase 2 study of Major Depressive Disorder and Anxiety Disorders, sponsored by National Institute of Mental Health (NIMH).

Recruiting
Registry status
Phase 2
Development phase
2,530
Enrollment target
1
Study location

NCT00018057: Recruiting Phase 2 study of Major Depressive Disorder and Anxiety Disorders, sponsored by National Institute of Mental Health (NIMH).

NCT00018057 is a Phase 2 study of Major Depressive Disorder and Anxiety Disorders that is actively recruiting participants, run by National Institute of Mental Health (NIMH). The registered enrollment target is 2,530 participants, above the 368-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (588% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00018057, a Phase 2 study of Major Depressive Disorder and Anxiety Disorders, is actively recruiting participants, sponsored by National Institute of Mental Health (NIMH).

RECRUITING
Registry status
Phase 2
Development phase
2,530 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

Clinician-rated report

Conditions Studied

Major Depressive Disorder Anxiety Disorders

Interventions

  • DRUG Fluoxetine
  • BEHAVIORAL Attention Bias Modification Training

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 2,530 participants
Start Date 2001-10-02
Est. Completion 2029-01-01
Phase Phase 2
National Institute of Mental Health (NIMH)

343 total trials

What NCT00018057 shows while recruiting

NCT00018057 is an interventional study that assigns participants to a tested intervention. Its 2,530 participants enrollment target places it among the larger protocols in the corpus, above the 368-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (588% higher).

The record links to 2 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Fluoxetine is the first listed.

NCT00018057 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT00018057 about?

NCT00018057 is a clinical study titled "Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders". 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 on...

What is the current status of trial NCT00018057?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 2,530 participants. The study started on 2001-10-02. Estimated completion is 2029-01-01.

What conditions does trial NCT00018057 study?

This clinical trial studies the following conditions: Major Depressive Disorder, Anxiety Disorders.

What interventions are being tested in trial NCT00018057?

The interventions under investigation include: Fluoxetine (DRUG), Attention Bias Modification Training (BEHAVIORAL).

Who is sponsoring clinical trial NCT00018057?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00018057 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Major Depressive Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00018057's enrollment target sits among peer trials

2,530 3rd of 282 higher than 280 of 282 other Major Depressive Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT00018057

Source: ClinicalTrials.gov NCT00018057, the US trial registry maintained by the National Library of Medicine. NCT00018057 (large enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.