RecruitingPhase 2

Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders

United States3,500 participantsStarted 2001-10-02

Plain-language 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. ...

Who can participate

Age range

8 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

Any current psychiatric diagnosis (Assessment relies on SCID)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is measuring anxiety and improvement using the Pediatric Anxiety Rating Scale and the Clinical Global Improvement Scale — can you explain what those assessments involve and how often my child would be evaluated during the study?
2Since this is a Phase 2 trial focused on neuro-cognitive correlates, does it involve brain imaging or cognitive testing, and what would that experience actually look like for my child?
3The trial covers both anxiety disorders and major depressive disorder — given my child's specific diagnosis, do you think their condition fits what this study is actually designed to study?
4Before considering this research study, should my child try an established standard treatment for pediatric anxiety first, and how does participating in research like this compare to going that route?
5Since this trial is still actively recruiting, what is the time commitment involved, and are there any aspects of the study schedule or procedures that might be difficult for our family to manage?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pediatric Anxiety Rating Scale (PARS)

Timeframe: Weekly

Clinical Global Improvement (CGI) Scale

Timeframe: Weekly

Trial details

NCT IDNCT00018057

SponsorNational Institute of Mental Health (NIMH)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2029-01-01

Contact for this trial

Daniel S Pine, M.D.

(301) 594-1318 daniel.pine@nih.gov

View on ClinicalTrials.gov More Anxiety Disorders trials

Plain-language summary