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

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT03924323
Collaborator
(none)
256
Enrollment
39
Locations
2
Arms
27.7
Actual Duration (Months)
6.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
256 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 30, 2019
Actual Primary Completion Date :
Sep 20, 2021
Actual Study Completion Date :
Sep 20, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Pediatric Anxiety Rating Scale (PARS) severity score [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 [Week 8]

    Response is defined as a 50% improvement on the PARS severity score for GAD

  2. Remission rate on the PARS [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) [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) [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.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Harmonex /ID# 233342 Dothan Alabama United States 36303
2 Woodland International Research Group /ID# 233348 Little Rock Arkansas United States 72211
3 Woodland Research Northwest, LLC /ID# 233366 Rogers Arkansas United States 72758-6442
4 ATP Clinical Research, Inc /ID# 233362 Costa Mesa California United States 92626-4607
5 ProScience Research Group /ID# 233374 Culver City California United States 90230-6632
6 Sun Valley Research Center /ID# 233343 Imperial California United States 92251-9401
7 MCB Clinical Research Centers /ID# 233372 Colorado Springs Colorado United States 80910
8 Emerson Clinical Research Inst /ID# 233371 Washington District of Columbia United States 20011
9 Indago Research and Health Cen /ID# 233364 Hialeah Florida United States 33012-4170
10 CNS Healthcare - Jacksonville /ID# 233352 Jacksonville Florida United States 32256-6039
11 Accel Research Sites-Maitland Clinical Research Unit /ID# 233368 Maitland Florida United States 32751
12 Medical Research Group of Central Florida /ID# 233357 Orange City Florida United States 32763
13 Clinical Neuroscience Solutions, Inc /ID# 233350 Orlando Florida United States 32801-2986
14 APG Research, LLC /ID# 233337 Orlando Florida United States 32803
15 University of South Florida Rothman Center of Neuropsychiatry /ID# 233356 Saint Petersburg Florida United States 33701-4708
16 Innovative Clinical Research, Inc. /ID# 233365 Tamarac Florida United States 33319-4985
17 Capstone Clinical Research /ID# 233354 Libertyville Illinois United States 60048-5341
18 Baber Research Group /ID# 233363 Naperville Illinois United States 60563-6502
19 Psychiatric Associates /ID# 233360 Overland Park Kansas United States 66221
20 Alivation Research /ID# 233338 Lincoln Nebraska United States 68526-9474
21 Center for Psychiatry and Behavioral Medicine Inc /ID# 233355 Las Vegas Nevada United States 89128-0819
22 Manhattan Behavioral Medicine PLLC /ID# 233351 New York New York United States 10036
23 Finger Lakes Clinical Research /ID# 233347 Rochester New York United States 14618-1609
24 Quest Therapeutics of Avon Lake /ID# 233367 Avon Lake Ohio United States 44012
25 Neuro-Behavioral Clinical Research, Inc. /ID# 233375 Canton Ohio United States 44720
26 University of Cincinnati /ID# 233341 Cincinnati Ohio United States 45219
27 UH Cleveland Medical Center /ID# 233373 Cleveland Ohio United States 44106
28 Midwest Clinical Research Center /ID# 233346 Dayton Ohio United States 45417
29 CincyScience /ID# 233359 West Chester Ohio United States 45069
30 SP Research, PLLC /ID# 233340 Oklahoma City Oklahoma United States 73112-8729
31 Central States Research /ID# 233339 Tulsa Oklahoma United States 74136
32 Coastal Carolina Research Center /ID# 233344 North Charleston South Carolina United States 29464
33 Houston Clinical Trials /ID# 233345 Bellaire Texas United States 77401-2928
34 Relaro Medical Trials /ID# 233369 Dallas Texas United States 75243
35 AIM Trials /ID# 233361 Plano Texas United States 75093
36 Focus Center, PC /ID# 233349 Ogden Utah United States 84405-4946
37 University of Virginia /ID# 233370 Charlottesville Virginia United States 22903
38 Northwest Clinical Research Center /ID# 233358 Bellevue Washington United States 98004
39 Core Clinical Research /ID# 233353 Everett Washington United States 98201

Sponsors and Collaborators

  • Allergan

Investigators

  • Study Director: ALLERGAN INC., Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03924323
Other Study ID Numbers:
  • SCT-MD-60
First Posted:
Apr 23, 2019
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:
Disease
Anxiety Disorders
Citalopram

Study Results

No Results Posted as of Sep 29, 2021