RecruitingPhase 2NCT00018057

Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders


Sponsor

National Institute of Mental Health (NIMH)

Enrollment

3,500 participants

Start Date

Oct 2, 2001

Study Type

INTERVENTIONAL

Conditions

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. ...


Eligibility

Min Age: 8 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study investigates the brain and thinking patterns in children and adults with anxiety disorders to better understand how anxiety affects the mind. You may be eligible if... - You are between 8 and 17 years old (juveniles) or 18 and 65 years old (adults) - You have an IQ above 70 - You speak English - You (or your parents) are able to give consent or assent - You have a current diagnosis of OCD, social phobia, separation anxiety, generalized anxiety disorder, or panic disorder (for the anxiety group) You may NOT be eligible if... - You do not speak English - You have an IQ of 70 or below - You are outside the eligible age ranges - You do not have a clinically significant anxiety disorder (for the anxiety group) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAttention Bias Modification Training

The intervention is computer-based. The active and control treatments have two components. In one component of the active intervention, subjects are asked to indicate the identity of a letter that appears behind a neutral face, opposite from an angry face. In another component of the active intervention, subjects are asked to identify numbers that are hidden within a puzzle, in locations distal from angry faces. In both components of the active intervention, subjects implicitly learn to shift their attention away from angry faces. This is because the faces are systematically arranged to be far removed from letters and numbers that need to be identified. The control arm of the intervention involves similar components. However, unlike in the intervention arm, angry faces appear in various locations near letters and numbers. Therefore, attention is not shaped in the control arm. This intervention requires five minutes per session and is administered before weekly psychotherapy sessions.

DRUGFluoxetine

Randomized assignment.

BEHAVIORALCognitive Behavioral Therapy

Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT00018057


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