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

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: Completed
• Conditions: Anxiety Disorders,Generalized Anxiety Disorder
• Intervention / Treatment: Drug: Escitalopram; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 273
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Pediatric Anxiety Rating Scale (PARS) Severity Score	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

Outcome Measure	Measure Description	Time Frame
Response Rate on the PARS	Response is defined as a 50% improvement on the PARS severity score for GAD	Week 8
Remission Rate on the PARS	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)	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)	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

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2019
• Primary Completion (Actual): September 20, 2021
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: April 19, 2019
• First Submitted That Met QC Criteria: April 19, 2019
• First Posted (Actual): April 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID 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