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

NCT ID: NCT03924323

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 273 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-30
• Study Completion Date: 2021-09-20

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.

Conditions

Anxiety Disorders,Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Escitalopram 10 mg/day

Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

8-weeks of treatment followed by 1-week taper down period

Placebo

Matching oral administration of placebo once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching oral administration of inactive substance once daily

Interventions

Escitalopram

8-weeks of treatment followed by 1-week taper down period

Intervention Type: DRUG

Placebo

Matching oral administration of inactive substance once daily

Intervention Type: OTHER

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).

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ALLERGAN INC.

Role: STUDY_DIRECTOR

Allergan

Locations

Harmonex /ID# 233342

Dothan, Alabama, United States

Woodland International Research Group /ID# 233348

Little Rock, Arkansas, United States

Woodland Research Northwest, LLC /ID# 233366

Rogers, Arkansas, United States

ATP Clinical Research, Inc /ID# 233362

Costa Mesa, California, United States

ProScience Research Group /ID# 233374

Culver City, California, United States

Sun Valley Research Center /ID# 233343

Imperial, California, United States

MCB Clinical Research Centers /ID# 233372

Colorado Springs, Colorado, United States

Emerson Clinical Research Inst /ID# 233371

Washington D.C., District of Columbia, United States

Innovative Clinical Research /ID# 233365

Fort Lauderdale, Florida, United States

Indago Research and Health Cen /ID# 233364

Hialeah, Florida, United States

CNS Healthcare - Jacksonville /ID# 233352

Jacksonville, Florida, United States

Accel Research Sites-Maitland Clinical Research Unit /ID# 233368

Maitland, Florida, United States

Medical Research Group of Central Florida /ID# 233357

Orange City, Florida, United States

Clinical Neuroscience Solutions, Inc /ID# 233350

Orlando, Florida, United States

APG Research, LLC /ID# 233337

Orlando, Florida, United States

University of South Florida Rothman Center of Neuropsychiatry /ID# 233356

St. Petersburg, Florida, United States

Capstone Clinical Research /ID# 233354

Libertyville, Illinois, United States

Baber Research Group /ID# 233363

Naperville, Illinois, United States

Psychiatric Associates /ID# 233360

Overland Park, Kansas, United States

Alivation Research /ID# 233338

Lincoln, Nebraska, United States

Center for Psychiatry and Behavioral Medicine Inc /ID# 233355

Las Vegas, Nevada, United States

Manhattan Behavioral Medicine PLLC /ID# 233351

New York, New York, United States

Finger Lakes Clinical Research /ID# 233347

Rochester, New York, United States

Quest Therapeutics of Avon Lake /ID# 233367

Avon Lake, Ohio, United States

Neuro-Behavioral Clinical Research, Inc. /ID# 233375

Canton, Ohio, United States

University of Cincinnati /ID# 233341

Cincinnati, Ohio, United States

UH Cleveland Medical Center /ID# 233373

Cleveland, Ohio, United States

Midwest Clinical Research Center /ID# 233346

Dayton, Ohio, United States

CincyScience /ID# 233359

West Chester, Ohio, United States

SP Research, PLLC /ID# 233340

Oklahoma City, Oklahoma, United States

Central States Research /ID# 233339

Tulsa, Oklahoma, United States

Coastal Carolina Research Center /ID# 233344

North Charleston, South Carolina, United States

Houston Clinical Trials /ID# 233345

Bellaire, Texas, United States

Relaro Medical Trials /ID# 233369

Dallas, Texas, United States

AIM Trials /ID# 233361

Plano, Texas, United States

Focus Center, PC /ID# 233349

Ogden, Utah, United States

University of Virginia /ID# 233370

Charlottesville, Virginia, United States

Northwest Clinical Research Center /ID# 233358

Bellevue, Washington, United States

Core Clinical Research /ID# 233353

Everett, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37074330 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SCT-MD-60

Identifier Type: -

Identifier Source: org_study_id