Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT02818751
Eligibility Criteria:
Inclusion Criteria:
Inclusion - Anxiety Subjects:
* Diagnostic and Statistical Manual-IV (Text Revision) criteria for generalized anxiety disorder diagnosed by the Anxiety Disorders Interview Schedule (ADIS-IV)
* Baseline Pediatric Anxiety Rating Scale (PARS) score ≥15 at baseline
* Ages 12-17 years 11 months old
* Fluent in English
* Provision of written informed consent by a legal guardian and written assent by the subject
* Tanner scale stages II-V, in order to include only post-pubescent subjects and minimize brain changes associated with the onset of puberty
* Does not have a history of intolerance, non-response or hypersensitivity to escitalopram
* No co-occurring Diagnostic and Statistical Manual-IV (Text Revision) diagnosis mood (except dysthymia, depression not otherwise specified), eating, pervasive developmental disorder or psychotic disorders
* Subjects will be excluded if there are any lifetime diagnosis of mental retardation (intelligence quotient \< 70)
* Subjects with any history of alcohol or drug dependence or any alcohol abuse within the past 6 months (nicotine dependence is permitted) will be excluded
* No new psychotherapy will be permitted during study participation and if the patient is engaged in psychotherapy, it must have been stable for 1 month prior to baseline
* Females will not be eligible to participate if pregnant, breast feeding or lactating.
Inclusion - Healthy Subjects:
* Ages of 12-17 years and 11 months
* No history of any Diagnostic and Statistical Manual-IV (Text Revision) Axis I disorders (nicotine dependence is permitted)
* No first-degree relatives with an affective or psychotic disorder
* No medications with central nervous system effects within 5 half-lives
* Fluent in English
* Tanner stage II-V
* Provision of informed consent and assent.
Exclusion Criteria:
Exclusion - Generalized Anxiety Disorder Patients \& Healthy Subjects:
* Contraindication to an magnetic resonance imaging (MRI) scan (e.g., braces or claustrophobia)
* An unstable medical or neurological illness that could influence fMRI or magnetic resonance spectroscopy results
* Subjects will be excluded if there are any lifetime diagnosis of mental retardation or intelligence quotient \< 70)
* A positive pregnancy test
* Adolescents will be excluded for treatment with a medication with central nervous system effects that requires more than 5 days of a screening period in order to minimize the length of time between screening and baseline and maximize patient safety, while recognizing that a longer taper period is required of some medications
* Adolescents with any history of major medical or neurological disorders that may result in neurofunctional or neurochemical abnormalities including loss of consciousness for \>10 minutes will be excluded
* No co-occurring Diagnostic and Statistical Manual-IV (Text Revision) diagnosis mood (other than dysthymia or Depression Not Otherwise Specified), eating, pervasive developmental disorder or psychotic disorders
* Subjects will be excluded if there are any lifetime diagnosis of mental retardation or intelligence quotient \< 70
* Subjects with any history of alcohol or drug dependence or any alcohol abuse within the past 6 months (nicotine dependence is permitted) will be excluded
* No new psychotherapy will be permitted during study participation and if the patient is engaged in psychotherapy, it must have been stable for 1 month prior to baseline
* Females will not be eligible to participate if pregnant, breast feeding or lactating
* The patient lives \>100 miles from the University of Cincinnati or is not able to attend follow-up visits
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT02818751
Study Brief:
Protocol Section:
NCT02818751