Cognitive Behavioral Therapy or Fluoxetine for Pediatric Anxiety

Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders

Recruiting Phase 2 Interventional Study
Anxiety Disorders Major Depressive Disorder
Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
8 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
3,500 (estimated)
Sponsor
National Institute of Mental Health (NIMH) · NIH
Who this trial is looking for

This trial is looking for children and young adults ages 8 to 17, and adults ages 18 to 65, who have anxiety disorders. Participants will undergo cognitive tests and brain scans over a year while receiving treatment with either cognitive behavioral therapy or fluoxetine.

Are You a Good Fit for This Trial?
Rules you out Major Depressive DisorderPost-Traumatic Stress DisorderConduct Disorder

You may be able to join if

  • I am between 8 and 17 years old or between 18 and 65 years old.
  • I can give my consent or assent to join the trial.
  • I have an IQ above 70.
  • I speak English.
  • I have a current diagnosis of an anxiety disorder.
  • I have ongoing anxiety symptoms that cause me distress.
  • I have ongoing symptoms or impairment from anxiety.

You may not be able to join if

  • I have a serious medical condition that interferes with brain scans.
  • I am pregnant.
  • I use any psychoactive substances or have suicidal thoughts.
  • I have been diagnosed with major depressive disorder.
  • I have a history of mania or psychosis.
  • I have used an SSRI before without success.
  • I have a moderate to severe substance use disorder.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 behavior…
Trial Locations
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Eligibility Criteria
* INCLUSION CRITERIA: ALL JUVENILE SUBJECTS * Age: 8-17 (subjects who consent as 17-year-olds but turn 18 during the course of the study will be eligible to complete all procedures completed by other subjects who consent as 17-year-olds but do not turn 18). * Consent: can give consent/assent (Pare…
Contacts

Daniel S Pine, M.D.

(301) 594-1318

daniel.pine@nih.gov

CONTACT