Neurofunctional Predictors of Escitalopram Treatment Response in Adolescents With Anxiety

Completed · Not applicable · Has a placebo group

Conditions studied: Anxiety

In brief

Neurofunctional Predictors of Escitalopram Treatment Response in Adolescents with Anxiety. To determine the effects of escitalopram on functional activation patterns during a Continuous Performance Task with Emotional and Neutral Distracters, the CPT-END. To examine baseline functional activity and functional connectivity profiles in the ventrolateral prefrontal cortex as markers of subsequent treatment response to escitalopram in adolescents with generalized anxiety disorder (GAD). To use proton magnetic resonance spectroscopy (1H MRS) to examine glutamatergic and γ-aminobutyric acid (GABA)-related abnormalities in the anterior cingulate in adolescents with GAD as compared to healthy adolescents.

Key facts

Study ID: NCT02818751
Run by: University of Cincinnati
People needed: 84
Starts: 2015-05-01
Expected to finish: 2020-05-01
Last updated by the study team: 2020-11-06

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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