Back to resultsA Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
Primary Purpose
Anxiety Disorders,Generalized Anxiety Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders,Generalized Anxiety Disorder
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).
Sites / Locations
- Harmonex /ID# 233342
- Woodland International Research Group /ID# 233348
- Woodland Research Northwest, LLC /ID# 233366
- ATP Clinical Research, Inc /ID# 233362
- ProScience Research Group /ID# 233374
- Sun Valley Research Center /ID# 233343
- MCB Clinical Research Centers /ID# 233372
- Emerson Clinical Research Inst /ID# 233371
- Innovative Clinical Research /ID# 233365
- Indago Research and Health Cen /ID# 233364
- CNS Healthcare - Jacksonville /ID# 233352
- Accel Research Sites-Maitland Clinical Research Unit /ID# 233368
- Medical Research Group of Central Florida /ID# 233357
- Clinical Neuroscience Solutions, Inc /ID# 233350
- APG Research, LLC /ID# 233337
- University of South Florida Rothman Center of Neuropsychiatry /ID# 233356
- Capstone Clinical Research /ID# 233354
- Baber Research Group /ID# 233363
- Psychiatric Associates /ID# 233360
- Alivation Research /ID# 233338
- Center for Psychiatry and Behavioral Medicine Inc /ID# 233355
- Manhattan Behavioral Medicine PLLC /ID# 233351
- Finger Lakes Clinical Research /ID# 233347
- Quest Therapeutics of Avon Lake /ID# 233367
- Neuro-Behavioral Clinical Research, Inc. /ID# 233375
- University of Cincinnati /ID# 233341
- UH Cleveland Medical Center /ID# 233373
- Midwest Clinical Research Center /ID# 233346
- CincyScience /ID# 233359
- SP Research, PLLC /ID# 233340
- Central States Research /ID# 233339
- Coastal Carolina Research Center /ID# 233344
- Houston Clinical Trials /ID# 233345
- Relaro Medical Trials /ID# 233369
- AIM Trials /ID# 233361
- Focus Center, PC /ID# 233349
- University of Virginia /ID# 233370
- Northwest Clinical Research Center /ID# 233358
- Core Clinical Research /ID# 233353
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Escitalopram 10 mg/day
Placebo
Arm Description
Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion
Matching oral administration of placebo once daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Response Rate on the PARS
Response is defined as a 50% improvement on the PARS severity score for GAD
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)
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03924323
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders,Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
273 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escitalopram 10 mg/day
Arm Type
Experimental
Arm Description
Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching oral administration of placebo once daily
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
8-weeks of treatment followed by 1-week taper down period
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching oral administration of inactive substance once daily
Primary Outcome Measure Information:
Title
Change in Pediatric Anxiety Rating Scale (PARS) Severity Score
Description
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.
Time Frame
Baseline to Week 8
Secondary Outcome Measure Information:
Title
Response Rate on the PARS
Description
Response is defined as a 50% improvement on the PARS severity score for GAD
Time Frame
Week 8
Title
Remission Rate on the PARS
Description
Remission is defined as PARS severity score for GAD ≤8 (using 6 PARS items: 2, 3, 4, 5, 6, and 7)
Time Frame
Week 8
Title
Change on the Clinical Global Impression of Severity (CGI-S)
Description
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.
Time Frame
Week 8
Title
Change on the Children's Global Assessment Scale (CGAS)
Description
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.
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALLERGAN INC.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Harmonex /ID# 233342
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Woodland International Research Group /ID# 233348
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Woodland Research Northwest, LLC /ID# 233366
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758-6442
Country
United States
Facility Name
ATP Clinical Research, Inc /ID# 233362
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626-4607
Country
United States
Facility Name
ProScience Research Group /ID# 233374
City
Culver City
State/Province
California
ZIP/Postal Code
90230-6632
Country
United States
Facility Name
Sun Valley Research Center /ID# 233343
City
Imperial
State/Province
California
ZIP/Postal Code
92251-9401
Country
United States
Facility Name
MCB Clinical Research Centers /ID# 233372
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Emerson Clinical Research Inst /ID# 233371
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
Innovative Clinical Research /ID# 233365
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Indago Research and Health Cen /ID# 233364
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012-4170
Country
United States
Facility Name
CNS Healthcare - Jacksonville /ID# 233352
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256-6039
Country
United States
Facility Name
Accel Research Sites-Maitland Clinical Research Unit /ID# 233368
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Medical Research Group of Central Florida /ID# 233357
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc /ID# 233350
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801-2986
Country
United States
Facility Name
APG Research, LLC /ID# 233337
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
University of South Florida Rothman Center of Neuropsychiatry /ID# 233356
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701-4708
Country
United States
Facility Name
Capstone Clinical Research /ID# 233354
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048-5341
Country
United States
Facility Name
Baber Research Group /ID# 233363
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563-6502
Country
United States
Facility Name
Psychiatric Associates /ID# 233360
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66221
Country
United States
Facility Name
Alivation Research /ID# 233338
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526-9474
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine Inc /ID# 233355
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128-0819
Country
United States
Facility Name
Manhattan Behavioral Medicine PLLC /ID# 233351
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Finger Lakes Clinical Research /ID# 233347
City
Rochester
State/Province
New York
ZIP/Postal Code
14618-1609
Country
United States
Facility Name
Quest Therapeutics of Avon Lake /ID# 233367
City
Avon Lake
State/Province
Ohio
ZIP/Postal Code
44012
Country
United States
Facility Name
Neuro-Behavioral Clinical Research, Inc. /ID# 233375
City
Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
University of Cincinnati /ID# 233341
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
UH Cleveland Medical Center /ID# 233373
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Midwest Clinical Research Center /ID# 233346
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
CincyScience /ID# 233359
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
SP Research, PLLC /ID# 233340
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112-8729
Country
United States
Facility Name
Central States Research /ID# 233339
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Coastal Carolina Research Center /ID# 233344
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Houston Clinical Trials /ID# 233345
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401-2928
Country
United States
Facility Name
Relaro Medical Trials /ID# 233369
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
AIM Trials /ID# 233361
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Focus Center, PC /ID# 233349
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405-4946
Country
United States
Facility Name
University of Virginia /ID# 233370
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Northwest Clinical Research Center /ID# 233358
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Core Clinical Research /ID# 233353
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Learn more about this trial
A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
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