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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 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.
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.
Conditions Studied
Interventions
- DRUG Fluoxetine
- BEHAVIORAL Attention Bias Modification Training
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,530 participants |
| Start Date | 2001-10-02 |
| Est. Completion | 2029-01-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00018057
The ClinicalTrials.gov registry entry for NCT00018057 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 2,530 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 368-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (588% higher). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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