PMID- 37074330
OWN - NLM
STAT- MEDLINE
DCOM- 20230421
LR  - 20230926
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Linking)
VI  - 33
IP  - 3
DP  - 2023 Apr
TI  - A Multicenter Double-Blind, Placebo-Controlled Trial of Escitalopram in Children 
      and Adolescents with Generalized Anxiety Disorder.
PG  - 91-100
LID - 10.1089/cap.2023.0004 [doi]
AB  - Objective: Generalized anxiety disorder (GAD) in children and adolescents is 
      associated with substantial morbidity and increases the risk of future 
      psychopathology. However, relatively few psychopharmacologic studies have 
      examined treatments for GAD in pediatric populations, especially in prepubertal 
      youth. Methods: Children and adolescents aged 7-17 years of age with a primary 
      diagnosis of GAD were treated with flexibly dosed escitalopram (10-20 mg daily, 
      n = 138) or placebo (n = 137) for 8 weeks. Efficacy measures included the 
      Pediatric Anxiety Rating Scale (PARS) for GAD, Clinical Global Impression of 
      Severity (CGI-S) scale, Children's Global Assessment Scale (CGAS); safety 
      measures included the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as 
      adverse events (AEs), vital signs, and electrocardiographic and laboratory 
      monitoring. Results: Escitalopram was superior to placebo in reducing anxiety 
      symptoms of GAD, as seen in the difference in mean change from baseline to week 8 
      on the PARS severity for GAD score (least squares mean difference = -1.42; 
      p = 0.028). Functional improvement, as reflected by CGAS score, was numerically 
      greater in escitalopram-treated patients compared with those receiving placebo 
      (p = 0.286), and discontinuation owing to AEs did not differ between the two 
      groups. Vital signs, weight, laboratory, and electrocardiographic results were 
      consistent with previous pediatric studies of escitalopram. Conclusions: 
      Escitalopram reduced anxiety symptoms and was well tolerated in pediatric 
      patients with GAD. These findings confirm earlier reports of escitalopram 
      efficacy in adolescents aged 12-17 years and extend the safety and tolerability 
      data to children with GAD aged 7-11 years. ClinicalTrials.gov Identifier: 
      NCT03924323.
FAU - Strawn, Jeffrey R
AU  - Strawn JR
AUID- ORCID: 0000-0002-7526-2641
AD  - Department of Psychiatry and Behavioral Neuroscience, College of Medicine, 
      University of Cincinnati, Cincinnati, Ohio, USA.
AD  - Anxiety Disorders Research Program, College of Medicine, University of 
      Cincinnati, Cincinnati, Ohio, USA.
AD  - Division of Child & Adolescent Psychiatry and Division of Clinical Pharmacology, 
      Department of Pediatrics, Cincinnati Children's Hospital Medical Center, 
      Cincinnati, Ohio, USA.
FAU - Moldauer, Leslie
AU  - Moldauer L
AD  - Syneos Health, Morrisville, North Carolina, USA.
FAU - Hahn, Rebekah D
AU  - Hahn RD
AD  - Syneos Health, Morrisville, North Carolina, USA.
FAU - Wise, Alexandria
AU  - Wise A
AD  - Syneos Health, Morrisville, North Carolina, USA.
FAU - Bertzos, Kristina
AU  - Bertzos K
AD  - Syneos Health, Morrisville, North Carolina, USA.
FAU - Eisenberg, Beth
AU  - Eisenberg B
AD  - Syneos Health, Morrisville, North Carolina, USA.
FAU - Greenberg, Edward
AU  - Greenberg E
AD  - AbbVie, Lake Bluff, Illinois, USA.
FAU - Liu, Chengcheng
AU  - Liu C
AD  - AbbVie, Madison, New Jersey, USA.
FAU - Gopalkrishnan, Mallika
AU  - Gopalkrishnan M
AD  - AbbVie, Madison, New Jersey, USA.
FAU - McVoy, Molly
AU  - McVoy M
AUID- ORCID: 0000-0003-4967-6055
AD  - University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
AD  - Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
FAU - Knutson, James A
AU  - Knutson JA
AD  - Core Clinical Research, Everett, Washington, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03924323
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 4O4S742ANY (Escitalopram)
RN  - 0DHU5B8D6V (Citalopram)
RN  - EC 2.7.7.- (Nucleotidyltransferases)
SB  - IM
EIN - J Child Adolesc Psychopharmacol. 2023 Jun;33(5):200. PMID: 37339444
CIN - J Child Adolesc Psychopharmacol. 2023 Sep;33(7):295-296. PMID: 37724946
MH  - Humans
MH  - Adolescent
MH  - Child
MH  - *Escitalopram
MH  - *Citalopram/adverse effects
MH  - Anxiety Disorders/drug therapy/diagnosis
MH  - Double-Blind Method
MH  - Nucleotidyltransferases/therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - adolescents
OT  - children
OT  - escitalopram
OT  - generalized anxiety disorder
OT  - selective serotonin reuptake inhibitor
OT  - treatment
EDAT- 2023/04/19 12:41
MHDA- 2023/04/21 06:41
CRDT- 2023/04/19 10:53
PHST- 2023/04/21 06:41 [medline]
PHST- 2023/04/19 12:41 [pubmed]
PHST- 2023/04/19 10:53 [entrez]
AID - 10.1089/cap.2023.0004 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2023 Apr;33(3):91-100. doi: 
      10.1089/cap.2023.0004.