Clinical trial NCT03924323: A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
Official title: A Randomized, Multicenter, Double-Blind, Flexibly-dosed, Efficacy and Safety Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anxiety Disorders,Generalized Anxiety Disorder
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-04-23
Enrollment: 273
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Pediatric Anxiety Rating Scale (PARS) Severity Score
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Response Rate on the PARS
timeFrame: Week 8
measure: Remission Rate on the PARS
timeFrame: Week 8
measure: Change on the Clinical Global Impression of Severity (CGI-S)
timeFrame: Week 8
measure: Change on the Children's Global Assessment Scale (CGAS)
timeFrame: Week 8
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex /ID# 233342
state: Alabama
city: Little Rock
country: United States
facility: Woodland International Research Group /ID# 233348
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest, LLC /ID# 233366
state: Arkansas
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc /ID# 233362
state: California
city: Culver City
country: United States
facility: ProScience Research Group /ID# 233374
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center /ID# 233343
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers /ID# 233372
state: Colorado
city: Washington
country: United States
facility: Emerson Clinical Research Inst /ID# 233371
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Innovative Clinical Research /ID# 233365
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Cen /ID# 233364
state: Florida
city: Jacksonville
country: United States
facility: CNS Healthcare - Jacksonville /ID# 233352
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites-Maitland Clinical Research Unit /ID# 233368
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida /ID# 233357
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc /ID# 233350
state: Florida
city: Orlando
country: United States
facility: APG Research, LLC /ID# 233337
state: Florida
city: Saint Petersburg
country: United States
facility: University of South Florida Rothman Center of Neuropsychiatry /ID# 233356
state: Florida
city: Libertyville
country: United States
facility: Capstone Clinical Research /ID# 233354
state: Illinois
city: Naperville
country: United States
facility: Baber Research Group /ID# 233363
state: Illinois
city: Overland Park
country: United States
facility: Psychiatric Associates /ID# 233360
state: Kansas
city: Lincoln
country: United States
facility: Alivation Research /ID# 233338
state: Nebraska
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine Inc /ID# 233355
state: Nevada
city: New York
country: United States
facility: Manhattan Behavioral Medicine PLLC /ID# 233351
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research /ID# 233347
state: New York
city: Avon Lake
country: United States
facility: Quest Therapeutics of Avon Lake /ID# 233367
state: Ohio
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc. /ID# 233375
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 233341
state: Ohio
city: Cleveland
country: United States
facility: UH Cleveland Medical Center /ID# 233373
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center /ID# 233346
state: Ohio
city: West Chester
country: United States
facility: CincyScience /ID# 233359
state: Ohio
city: Oklahoma City
country: United States
facility: SP Research, PLLC /ID# 233340
state: Oklahoma
city: Tulsa
country: United States
facility: Central States Research /ID# 233339
state: Oklahoma
city: North Charleston
country: United States
facility: Coastal Carolina Research Center /ID# 233344
state: South Carolina
city: Bellaire
country: United States
facility: Houston Clinical Trials /ID# 233345
state: Texas
city: Dallas
country: United States
facility: Relaro Medical Trials /ID# 233369
state: Texas
city: Plano
country: United States
facility: AIM Trials /ID# 233361
state: Texas
city: Ogden
country: United States
facility: Focus Center, PC /ID# 233349
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia /ID# 233370
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center /ID# 233358
state: Washington
city: Everett
country: United States
facility: Core Clinical Research /ID# 233353
state: Washington
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: