Neurofunctional Predictors of Escitalopram Treatment Response in Adolescents With Anxiety (FiESTAA)
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ClinicalTrials.gov Identifier: NCT02818751 |
Recruitment Status :
Completed
First Posted : June 30, 2016
Last Update Posted : November 6, 2020
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Condition or disease | Intervention/treatment | Phase |
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Anxiety | Drug: Escitalopram Other: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Neurofunctional Predictors of Escitalopram Treatment Response in Adolescents With Anxiety |
Actual Study Start Date : | May 2015 |
Actual Primary Completion Date : | May 2019 |
Actual Study Completion Date : | May 2020 |

Arm | Intervention/treatment |
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Experimental: Escitalopram
Patients being randomized to receive escitalopram, at an initial dose of 5 mg (oral) daily for 2 days. On day 3, escitalopram will be increased to 10 mg daily and continued for 7 days. Then, on day 10, escitalopram will be increased to 15 mg. At the week 4 visit, the dose of escitalopram may be increased to 20 mg, based on the investigator's clinical judgment and if significant anxiety symptoms are still present.
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Drug: Escitalopram
Patients being randomized to receive escitalopram.
Other Name: Lexapro |
Placebo Comparator: Placebo
Patients will receive placebo (sugar pill) at an initial dose of 5 mg daily for 2 days. On day 3, placebo will be increased to 10 mg daily and continued for 7 days to match the experimental group.
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Other: Placebo
Patients being randomized to receive placebo.
Other Name: Sugar Pill |
No Intervention: Healthy Controls
Healthy adolescents will receive fMRI scans at the same time points, which will provide assessments of the stability of neurophysiologic measures and will be used to adjust and interpret comparisons within the patients (i.e., whether patient values are changing toward or away from those of healthy adolescents).
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- Early escitalopram-related functional brain activity changes during emotional processing [ Time Frame: From baseline to week 2 of treatment ]To determine if escitalopram treatment (over a 2 week period) increases functional brain activation during the processing of emotional images while performing a continuous processing task with emotional and neutral distracters (CPT-END) (also over a 2 week period).
- Change in functional activity in the ventrolateral prefrontal cortex (from baseline to week 2) and improvement in Pediatric Anxiety Rating Scale score (at week 8/early termination) [ Time Frame: from baseline to week 8 (or early termination) ]To determine if the change in functional activity in the ventrolateral prefrontal cortex (from baseline to week 2) predicts improvement in Pediatric Anxiety Rating Scale score from baseline to week 8/early termination.
- Change in functional connectivity between the ventrolateral prefrontal cortex and the amygdala (from baseline to week 2) and improvement in Pediatric Anxiety Rating Scale score (at week 8/early termination) [ Time Frame: from baseline to week 8 (or early termination) ]To determine if the change in functional connectivity between the ventrolateral prefrontal cortex and the amygdala (from baseline to week 2) predicts improvement in Pediatric Anxiety Rating Scale score from baseline to week 8/early termination.
- Change in glutamate concentrations in the anterior cingulate cortex predict improvement in Pediatric Anxiety Rating Scale score from baseline to week 8/early termination. [ Time Frame: from baseline to week 8 (or early termination) ]To determine if change in glutamate concentrations in the anterior cingulate cortex predict improvement in Pediatric Anxiety Rating Scale score from baseline to week 8/early termination.
- Change in γ-aminobutyric acid concentrations in the anterior cingulate (from baseline to week 2) predicts improvement in Pediatric Anxiety Rating Scale score from baseline to week 8 (or early termination) [ Time Frame: from baseline to week 8 (or early termination) ]To determine if the change in γ-aminobutyric acid concentrations in the anterior cingulate (from baseline to week 2) predicts improvement in Pediatric Anxiety Rating Scale score from baseline to week 8 (or early termination)

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Ages Eligible for Study: | 12 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818751
United States, Ohio | |
University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience | |
Cincinnati, Ohio, United States, 45219 |
Principal Investigator: | Jeffrey Strawn | University of Cincinnati |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jeffrey Strawn, MD, Associate Professor of Psychiatry, University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT02818751 |
Other Study ID Numbers: |
Strawn FiESTAA K23MH106037 ( U.S. NIH Grant/Contract ) |
First Posted: | June 30, 2016 Key Record Dates |
Last Update Posted: | November 6, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Anxiety Adolescents with Anxiety |
Anxiety Disorders Mental Disorders Citalopram Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |