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

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ClinicalTrials.gov Identifier: NCT03924323
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Generalized Anxiety Disorder Drug: Escitalopram Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : July 2, 2021
Estimated Study Completion Date : July 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  1. 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 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)


Secondary Outcome Measures :
  1. Response rate on the PARS [ Time Frame: Week 8 ]
    Response is defined as a 50% improvement on the PARS severity score for GAD

  2. 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)

  3. Change on the Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline, 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.

  4. Change on the Children's Global Assessment Scale (CGAS) [ Time Frame: Baseline, 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.



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924323


Contacts
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Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

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Locations
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United States, Alabama
Harmonex Recruiting
Dothan, Alabama, United States, 36303
Contact: Study Coordinator    334-836-2000      
United States, Arkansas
Woodland International Research Group, LLC Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Study Coordinator    501-221-8681      
Woodland Research Northwest, LLC Recruiting
Rogers, Arkansas, United States, 72758
Contact: Study Coordinator    501-221-8681      
United States, California
ATP Clinical Research Inc Recruiting
Costa Mesa, California, United States, 92626
Contact: Study Coordinator    714-277-4472      
Sun Valley Research Center, Inc. Recruiting
Imperial, California, United States, 92251
Contact: Study Coordinator    760-545-0123      
United States, Florida
Indago Research and Health Center, Inc. Recruiting
Hialeah, Florida, United States, 33012
Contact: Study Coordinator    305-825-6588      
Clinical Neuroscience Solutions, Inc. Recruiting
Jacksonville, Florida, United States, 32256
Contact: Study Coordinator    904-281-5757      
Innovative Clinical Research, Inc. Recruiting
North Miami, Florida, United States, 33161
Contact: Study Coordinator    305-722-8444      
Medical Research Group of Central Florida Recruiting
Orange City, Florida, United States, 32763
Contact: Study Coordinator    386-775-7627      
Clinical Neuroscience Solutions, Inc. Recruiting
Orlando, Florida, United States, 32801
Contact: Study Coordinator    407-425-5100      
APG Research LLC Recruiting
Orlando, Florida, United States, 32803
Contact: Study Coordinator    407-222-9224      
University of South Florida Not yet recruiting
Saint Petersburg, Florida, United States, 33701
Meridien Research, Inc. Not yet recruiting
Winter Park, Florida, United States, 32789
United States, Illinois
Capstone Clinical Research Recruiting
Libertyville, Illinois, United States, 60048
Contact: Study Coordinator    847-549-7214      
AMR Baber Research Inc Recruiting
Naperville, Illinois, United States, 60563
Contact: Study Coordinator    630-272-4844      
United States, Kansas
Psychiatric Associates Recruiting
Overland Park, Kansas, United States, 66211
Contact: Study Coordinator    913-438-8221      
United States, Nebraska
Alivation Research Recruiting
Lincoln, Nebraska, United States, 68526
Contact: Study Coordinator    402-817-2235      
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Inc. Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Study Coordinator    702-838-0742      
United States, New York
Manhattan Behavioral Medicine, PLLC Recruiting
New York, New York, United States, 10036
Contact: Study Coordinator    646-678-4196      
Finger Lakes Clinical Research Recruiting
Rochester, New York, United States, 14618
Contact: Study Coordinator    585-241-3243      
United States, Ohio
Quest Therapeutics of Avon Lake Not yet recruiting
Avon Lake, Ohio, United States, 44012
UC Health, LLC Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Study Coordinator    513-558-4315      
Midwest Clinical Research Center, LLC Recruiting
Dayton, Ohio, United States, 45417
Contact: Study Coordinator    937-424-1050      
CincyScience Recruiting
West Chester, Ohio, United States, 45069
Contact: Study Coordinator    513-229-7585      
United States, Oklahoma
SP Research, PLLC Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Study Coordinator    405-753-4994      
Central States Research, LLC Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Study Coordinator    918-645-5400      
United States, South Carolina
Coastal Carloina Research Center Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: Study Coordinator    843-856-3784      
United States, Texas
Houston Clinical Trials LLC Recruiting
Bellaire, Texas, United States, 77401
Contact: Study Coordinator    281-738-2642      
AIM Trials LLC Recruiting
Plano, Texas, United States, 75025
Contact: Study Coordinator    972-325-1573      
United States, Utah
Focus CRC Inc Recruiting
South Ogden, Utah, United States, 84405
Contact: Study Coordinator    801-721-6393      
United States, Washington
Northwest Clinical Research Center Recruiting
Bellevue, Washington, United States, 98007
Contact: Study Coordinator    425-453-0404      
Core Clinical Research Recruiting
Everett, Washington, United States, 98201
Contact: Study Coordinator    425-443-9551      
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Arlene Lum Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03924323     History of Changes
Other Study ID Numbers: SCT-MD-60
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexetimide
Citalopram
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents