A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder

October 21, 2022 updated by: AbbVie

A Randomized, Multicenter, Double-Blind, Flexibly-dosed, Efficacy and Safety Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder

This is a study in minors (7 to 17 years old) diagnosed with generalized anxiety disorder (GAD) and evaluated using standard questionnaires as having at least moderate severity of GAD. Participating minors will be assigned to receive either the study drug escitalopram or a pill without any drug in it called a placebo. The purpose of this research is to study the safety and effectiveness of escitalopram in minors with GAD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
273

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Harmonex /ID# 233342
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group /ID# 233348
      • Rogers, Arkansas, United States, 72758-6442
        • Woodland Research Northwest, LLC /ID# 233366
    • California
      • Costa Mesa, California, United States, 92626-4607
        • ATP Clinical Research, Inc /ID# 233362
      • Culver City, California, United States, 90230-6632
        • ProScience Research Group /ID# 233374
      • Imperial, California, United States, 92251-9401
        • Sun Valley Research Center /ID# 233343
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • MCB Clinical Research Centers /ID# 233372
    • District of Columbia
      • Washington, District of Columbia, United States, 20011
        • Emerson Clinical Research Inst /ID# 233371
    • Florida
      • Fort Lauderdale, Florida, United States, 33319
        • Innovative Clinical Research /ID# 233365
      • Hialeah, Florida, United States, 33012-4170
        • Indago Research and Health Cen /ID# 233364
      • Jacksonville, Florida, United States, 32256-6039
        • CNS Healthcare - Jacksonville /ID# 233352
      • Maitland, Florida, United States, 32751
        • Accel Research Sites-Maitland Clinical Research Unit /ID# 233368
      • Orange City, Florida, United States, 32763
        • Medical Research Group of Central Florida /ID# 233357
      • Orlando, Florida, United States, 32801-2986
        • Clinical Neuroscience Solutions, Inc /ID# 233350
      • Orlando, Florida, United States, 32803
        • APG Research, LLC /ID# 233337
      • Saint Petersburg, Florida, United States, 33701-4708
        • University of South Florida Rothman Center of Neuropsychiatry /ID# 233356
    • Illinois
      • Libertyville, Illinois, United States, 60048-5341
        • Capstone Clinical Research /ID# 233354
      • Naperville, Illinois, United States, 60563-6502
        • Baber Research Group /ID# 233363
    • Kansas
      • Overland Park, Kansas, United States, 66221
        • Psychiatric Associates /ID# 233360
    • Nebraska
      • Lincoln, Nebraska, United States, 68526-9474
        • Alivation Research /ID# 233338
    • Nevada
      • Las Vegas, Nevada, United States, 89128-0819
        • Center for Psychiatry and Behavioral Medicine Inc /ID# 233355
    • New York
      • New York, New York, United States, 10036
        • Manhattan Behavioral Medicine PLLC /ID# 233351
      • Rochester, New York, United States, 14618-1609
        • Finger Lakes Clinical Research /ID# 233347
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Quest Therapeutics of Avon Lake /ID# 233367
      • Canton, Ohio, United States, 44720
        • Neuro-Behavioral Clinical Research, Inc. /ID# 233375
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati /ID# 233341
      • Cleveland, Ohio, United States, 44106
        • UH Cleveland Medical Center /ID# 233373
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center /ID# 233346
      • West Chester, Ohio, United States, 45069
        • CincyScience /ID# 233359
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112-8729
        • SP Research, PLLC /ID# 233340
      • Tulsa, Oklahoma, United States, 74136
        • Central States Research /ID# 233339
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Coastal Carolina Research Center /ID# 233344
    • Texas
      • Bellaire, Texas, United States, 77401-2928
        • Houston Clinical Trials /ID# 233345
      • Dallas, Texas, United States, 75243
        • Relaro Medical Trials /ID# 233369
      • Plano, Texas, United States, 75093
        • AIM Trials /ID# 233361
    • Utah
      • Ogden, Utah, United States, 84405-4946
        • Focus Center, PC /ID# 233349
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia /ID# 233370
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center /ID# 233358
      • Everett, Washington, United States, 98201
        • Core Clinical Research /ID# 233353

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject's parent/legal representative must give written informed consent, including privacy authorization, prior to study participation. The subject will complete an informed assent prior to study participation.
  • Subject meets DSM-5 criteria for a primary diagnosis of GAD at screening established by a comprehensive psychiatric evaluation and confirmed/supported using the Mini-International Neuropsychiatric Interview for children and adolescents (MINI Kid).
  • Male subjects who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception from the time of informed consent until 14 days after the last dose of study drug.
  • Female subjects who are sexually active and are of childbearing potential must use, with their partner, an approved method of highly effective contraception from the time of informed consent until 14 days after the last dose of study drug.
  • Female subjects who are not of childbearing potential do not need to use any methods of contraception. This includes preadolescent and adolescent females who have not reached menarche. - Subject must have venous access enough to allow blood sampling and be compliant with blood draws as per the protocol.

Exclusion Criteria:

  • Current diagnosis of MDD, attention-deficit/hyperactivity disorder, or lifetime diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, feeding and/or eating disorder, obsessive-compulsive disorder, conduct disorder, oppositional defiant disorder, post-traumatic stress disorder, panic disorder, or pervasive development disorder.
  • Suspected or previously diagnosed intellectual disability disorder.
  • One or more first-degree relatives with diagnosed bipolar I disorder.
  • History of seizure disorder (other than febrile seizures).
  • History of electroconvulsive therapy at any time during the subject's lifetime.
  • Known hypersensitivity to escitalopram (escitalopram oxalate) or citalopram or any of the inactive ingredients or had frequent or severe allergic reactions to multiple medications.
  • Taking any medications that are contraindicated to escitalopram (escitalopram oxalate).
  • Inability to speak, read, or understand English well enough to complete the assessments.
  • No active suicidal ideation or lifetime history of suicidal behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Escitalopram 10 mg/day
Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion
Drug: Escitalopram
8-weeks of treatment followed by 1-week taper down period
Placebo Comparator: Placebo
Matching oral administration of placebo once daily
Other: Placebo
Matching oral administration of inactive substance once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pediatric Anxiety Rating Scale (PARS) Severity Score
Time Frame: Baseline to Week 8
The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms associated with common anxiety disorders including generalized anxiety disorder (GAD) in children. The PARS severity score for GAD will be assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist derived by summing 5 of the 7 severity/impairment/interference items (2, 3, 5, 6, and 7) each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.
Baseline to Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Response Rate on the PARS
Time Frame: Week 8
Response is defined as a 50% improvement on the PARS severity score for GAD
Week 8
Remission Rate on the PARS
Time Frame: Week 8
Remission is defined as PARS severity score for GAD ≤8 (using 6 PARS items: 2, 3, 4, 5, 6, and 7)
Week 8
Change on the Clinical Global Impression of Severity (CGI-S)
Time Frame: Week 8
Remission rate on CGI-S at acute treatment endpoint (Week 8). Remission rate is defined as the percentage of subjects having a CGI-S score ≤2 at endpoint. CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients.
Week 8
Change on the Children's Global Assessment Scale (CGAS)
Time Frame: Week 8
Remission rate on the CGAS at acute treatment endpoint (Week 8). Functional remission is defined as CGAS >70. The CGAS used is a 100-point scale ranging from 1 to 100, with higher scores indicating better functioning.
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCT-MD-60

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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