Examining brain function in children with anxiety disorders

Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders

This study is testing how brain function in kids with anxiety disorders changes after they receive either therapy or medication, to see if it helps improve their symptoms.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 3500 (estimated)
• Ages: 8 Years to 65 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 2 sites (Bethesda, Maryland and 1 other locations)
• Trial ID: NCT00018057 on ClinicalTrials.gov

What this trial studies

This study investigates the relationship between neurocognitive features and clinical symptoms in pediatric anxiety disorders using advanced imaging techniques like fMRI and M/EEG. Participants, aged 8-17 and adults aged 18-65, will undergo assessments before and after receiving either cognitive behavioral therapy (CBT) or fluoxetine, a common antidepressant. The study aims to compare healthy youth with symptomatic patients to understand how cognitive features relate to treatment responses over a year. The findings could provide insights into the underlying mechanisms of anxiety disorders and their treatment.

Who should consider this trial

Good fit: Ideal candidates include children aged 8-17 and adults aged 18-65 with anxiety disorders who are medication-free and can provide consent or assent.

Not a fit: Patients with severe cognitive impairments or those who do not speak English may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for pediatric anxiety disorders based on neurocognitive profiles.

How similar studies have performed: Other studies have shown promise in using neuroimaging to understand anxiety disorders, suggesting that this approach could yield valuable insights.

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 (Parents will provide consent; minors will provide assent)
* IQ: all subjects will have IQ\>70 (Assessment relies on either a WASI or assessment by trained clinical staff during the subject s screening visit. Completion of required activities during the screening visit requires an IQ above 70.)
* Language: all subjects will speak English (Tasks in this protocol have not been validated in languages other than English)

ALL ADULT SUBJECTS

* Age: 18-65
* Consent: can give consent
* IQ: all subjects will have IQ\>70 (Assessment relies on either a WASI or assessment by trained clinical staff during the subject s screening visit. Completion of required activities during the screening visit requires an IQ above 70.)
* Language: all subjects will speak English (Tasks in this protocol have not been validated in languages other than English)

ALL SUBJECTS WITH AN ANXIETY DISORDER

* Diagnosis: Current Diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder (Based on K-SADS (juveniles) or SCID (adults))
* Symptom Severity: Clinically significant, ongoing anxiety symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)
* Clinical Impairment: Clinically significant, ongoing distress or impairment from anxiety (This will be documented by clinician review with patients and their families during at least two visits with families.)

ALL PREVIOUSLY ENROLLED ADOLESCENT PATIENTS, CHILD AND ADULT HEALTHY VOLUNTEERS, AND ALL HEALTHY VOLUNTEERS TURNED PATIENTS

* Diagnosis: Current Diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder; No current diagnosis (Based on K-SADS (juveniles) or SCID (adults))
* Clinical Impairment (as applicable): Clinically significant, ongoing symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)
* Symptom Severity (as applicable): Clinically significant, ongoing symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)

EXCLUSION CRITERIA:

ALL SUBJECTS

* Any serious medical condition or condition that interferes with fMRI or M/EEG scanning, and for patients electing medication, any condition that increases risk of SSRI treatment. (All patients will complete a medical history. Healthy volunteer participants will be medication- free and have no current serious medical conditions, based on a review of their medical history. Subjects only will be excluded from the MRI portions of the study based on this exclusion criterion.)
* Pregnancy (Subjects only will be excluded from the MRI portions of the study based on this exclusion criterion.)
* Current use of any psychoactive substance; current suicidal ideation; current diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to require pharmacotherapy. (These factors could complicate treatment with an SSRI. No subject on medication will be accepted into the trial. Subjects will not be taken off of medications to enter the trial.)
* Current diagnoses, major depressive disorder (MDD), post-traumatic distress disorder, conduct disorder. (These factors may be affected by SSRI treatment, influencing ability to detect effects on anxiety/symptoms of depression. Of note, subjects who present with a diagnosis of MDD will not be eligible for inclusion at the outset of the study. However, youth with anxiety disorders frequently develop MDD when followed over time. Subjects will be allowed to remain in the study if they develop these diagnoses after enrollment.)
* Past or current history of mania, psychosis, or severe pervasive developmental disorder. (These factors may be affected by SSRI treatment, influencing ability to detect effects on anxiety/symptoms of depression. Of note, subjects who present with a diagnosis of MDD will not be eligible for inclusion at the outset of the study. However, youth with anxiety disorders frequently develop MDD when followed over time. Subjects will be allowed to remain in the study if they develop these diagnoses after enrollment.)
* Recent use of an SSRI with failure to respond or tolerate SSRI treatment at an adequate dose and duration. (This is designed to exclude subjects who have failed a trial of an SSRI for their current problem with anxiety. For previously enrolled participants, including patients and healthy volunteers, current use of an SSRI does not exclude participation from follow-up research tasks.)
* History of any (excepting nicotine-related and cannabis-related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).

HEALTHY ADULT SUBJECTS

-Any current psychiatric diagnosis (Assessment relies on SCID)

Where this trial is running

Bethesda, Maryland and 1 other locations

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
• University of Maryland, College Park — College Park, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Daniel S Pine, M.D. — National Institute of Mental Health (NIMH)
• Study coordinator: Daniel S Pine, M.D.

Conditions: Anxiety Disorders, Major Depressive Disorder, fMRI, Emotion, Normal Volunteers, Magnetic Resonance Imaging, CBT