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
1 other identifier
interventional
273
1 country
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2019
Typical duration for phase_4
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2019
CompletedFirst Posted
Study publicly available on registry
April 23, 2019
CompletedStudy Start
First participant enrolled
May 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2021
CompletedResults Posted
Study results publicly available
November 14, 2022
CompletedNovember 14, 2022
October 1, 2022
2.3 years
April 19, 2019
September 20, 2022
October 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Response Rate on the PARS
Week 8
Remission Rate on the PARS
Week 8
Change on the Clinical Global Impression of Severity (CGI-S)
Week 8
Change on the Children's Global Assessment Scale (CGAS)
Week 8
Study Arms (2)
Escitalopram 10 mg/day
EXPERIMENTALOral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion
Placebo
PLACEBO COMPARATORMatching oral administration of placebo once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (39)
Harmonex /ID# 233342
Dothan, Alabama, 36303, United States
Woodland International Research Group /ID# 233348
Little Rock, Arkansas, 72211, United States
Woodland Research Northwest, LLC /ID# 233366
Rogers, Arkansas, 72758-6442, United States
ATP Clinical Research, Inc /ID# 233362
Costa Mesa, California, 92626-4607, United States
ProScience Research Group /ID# 233374
Culver City, California, 90230-6632, United States
Sun Valley Research Center /ID# 233343
Imperial, California, 92251-9401, United States
MCB Clinical Research Centers /ID# 233372
Colorado Springs, Colorado, 80910, United States
Emerson Clinical Research Inst /ID# 233371
Washington D.C., District of Columbia, 20011, United States
Innovative Clinical Research /ID# 233365
Fort Lauderdale, Florida, 33319, United States
Indago Research and Health Cen /ID# 233364
Hialeah, Florida, 33012-4170, United States
CNS Healthcare - Jacksonville /ID# 233352
Jacksonville, Florida, 32256-6039, United States
Accel Research Sites-Maitland Clinical Research Unit /ID# 233368
Maitland, Florida, 32751, United States
Medical Research Group of Central Florida /ID# 233357
Orange City, Florida, 32763, United States
Clinical Neuroscience Solutions, Inc /ID# 233350
Orlando, Florida, 32801-2986, United States
APG Research, LLC /ID# 233337
Orlando, Florida, 32803, United States
University of South Florida Rothman Center of Neuropsychiatry /ID# 233356
St. Petersburg, Florida, 33701-4708, United States
Capstone Clinical Research /ID# 233354
Libertyville, Illinois, 60048-5341, United States
Baber Research Group /ID# 233363
Naperville, Illinois, 60563-6502, United States
Psychiatric Associates /ID# 233360
Overland Park, Kansas, 66221, United States
Alivation Research /ID# 233338
Lincoln, Nebraska, 68526-9474, United States
Center for Psychiatry and Behavioral Medicine Inc /ID# 233355
Las Vegas, Nevada, 89128-0819, United States
Manhattan Behavioral Medicine PLLC /ID# 233351
New York, New York, 10036, United States
Finger Lakes Clinical Research /ID# 233347
Rochester, New York, 14618-1609, United States
Quest Therapeutics of Avon Lake /ID# 233367
Avon Lake, Ohio, 44012, United States
Neuro-Behavioral Clinical Research, Inc. /ID# 233375
Canton, Ohio, 44720, United States
University of Cincinnati /ID# 233341
Cincinnati, Ohio, 45219, United States
UH Cleveland Medical Center /ID# 233373
Cleveland, Ohio, 44106, United States
Midwest Clinical Research Center /ID# 233346
Dayton, Ohio, 45417, United States
CincyScience /ID# 233359
West Chester, Ohio, 45069, United States
SP Research, PLLC /ID# 233340
Oklahoma City, Oklahoma, 73112-8729, United States
Central States Research /ID# 233339
Tulsa, Oklahoma, 74136, United States
Coastal Carolina Research Center /ID# 233344
North Charleston, South Carolina, 29405, United States
Houston Clinical Trials /ID# 233345
Bellaire, Texas, 77401-2928, United States
Relaro Medical Trials /ID# 233369
Dallas, Texas, 75243, United States
AIM Trials /ID# 233361
Plano, Texas, 75093, United States
Focus Center, PC /ID# 233349
Ogden, Utah, 84405-4946, United States
University of Virginia /ID# 233370
Charlottesville, Virginia, 22903, United States
Northwest Clinical Research Center /ID# 233358
Bellevue, Washington, 98007, United States
Core Clinical Research /ID# 233353
Everett, Washington, 98201, United States
Related Publications (1)
Strawn JR, Moldauer L, Hahn RD, Wise A, Bertzos K, Eisenberg B, Greenberg E, Liu C, Gopalkrishnan M, McVoy M, Knutson JA. A Multicenter Double-Blind, Placebo-Controlled Trial of Escitalopram in Children and Adolescents with Generalized Anxiety Disorder. J Child Adolesc Psychopharmacol. 2023 Apr;33(3):91-100. doi: 10.1089/cap.2023.0004.
PMID: 37074330DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ALLERGAN INC.
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2019
First Posted
April 23, 2019
Study Start
May 30, 2019
Primary Completion
September 20, 2021
Study Completion
September 20, 2021
Last Updated
November 14, 2022
Results First Posted
November 14, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- 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/
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.