Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 8 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 1 year
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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)."
- "The study uses neurocognitive tasks, functional magnetic resonance imaging (fMRI), as well as magneto- and electro-encephalography (M/EEG)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how anxiety is linked to brain activity, attention, and memory, mainly in children and teens. Over one year, it follows patients before and after talk therapy called CBT or the medicine fluoxetine, and compares them with healthy volunteers. The study also includes adults.
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. ...
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Children and teens must be ages 8–17 when they join. Adults must be ages 18–65.
- Adults must agree to join. Children and teens must agree, and a parent must give permission.
- Must speak English and have an IQ score above 70, based on testing or a staff review.
- Patients must have OCD (unwanted thoughts and repeated actions), social anxiety, separation anxiety, ongoing worry, or panic disorder.
- Patients must have ongoing anxiety that causes serious distress or problems in daily life. Staff check this over at least two visits.
- The study also includes healthy volunteers. Previously enrolled participants may have one of the listed conditions or no current diagnosis.
Who can't join
- Serious health problems, conditions that interfere with brain scans, or conditions that make SSRI medicines unsafe. The listing says this rule excludes people only from MRI scans.
- Pregnancy excludes people only from MRI scans.
- Current use of medicines or substances that affect the mind, intent to act on suicidal thoughts, or ADHD that needs medicine. People will not be taken off medicine to join.
- Major depression, post-traumatic stress disorder, or conduct disorder at entry. Participants may stay if these develop after joining.
- Past or current mania (extreme high mood or energy), psychosis (loss of touch with reality), or a severe disorder affecting development.
- A recent full trial of an SSRI medicine that did not help or caused side effects the person could not tolerate. Previously enrolled participants taking an SSRI may still do follow-up research tasks.
- A history of moderate or severe substance use disorder, except problems involving nicotine or cannabis.
- Healthy adult volunteers cannot have a current mental health diagnosis.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 as indicated by the presence of intent for engaging in suicidal behaviors; 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)
Study sites (2)
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892NIH Clinical Center Office of Patient Recruitment (OPR) · Study contact · 800-411-1222 ext. TTY dial 711 · ccopr@nih.govMore trials in Bethesda
- University of Maryland, College Park · College Park, MD 20742Nathan Fox, Ph.D. · Study contact · Not Listed · fox@umd.eduMore trials in College Park