Document Detail


Baseline factors predicting placebo response to treatment in children and adolescents with autism spectrum disorders: a multisite randomized clinical trial.
MedLine Citation:
PMID:  24061784     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
IMPORTANCE: The finding of factors that differentially predict the likelihood of response to placebo over that of an active drug could have a significant impact on study design in this population.
OBJECTIVE: To identify possible nonspecific, baseline predictors of response to intervention in a large randomized clinical trial of children and adolescents with autism spectrum disorders.
DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of citalopram hydrobromide for children and adolescents with autism spectrum disorders and prominent repetitive behavior. Baseline data at study entry were examined with respect to final outcome to determine if response predictors could be identified. A total of 149 children and adolescents 5 to 17 years of age (mean [SD] age, 9.4 [3.1] years) from 6 academic centers were randomly assigned to citalopram (n = 73) or placebo (n = 76). Participants had autistic disorder, Asperger syndrome, or pervasive developmental disorder, not otherwise specified; had illness severity ratings that were moderate or more than moderate on the Clinical Global Impression-Severity scale; and scored moderate or more than moderate on compulsive behaviors measured with the modified Children's Yale-Brown Obsessive-Compulsive Scale.
INTERVENTIONS: Twelve weeks of treatment with citalopram (10 mg/5 mL) or placebo. The mean (SD) maximum dose of citalopram was 16.5 (6.5) mg by mouth daily (maximum dose, 20 mg/d).
MAIN OUTCOMES AND MEASURES: A positive response was defined as having a score of at least much improved on the Clinical Global Impression-Improvement scale at week 12. Baseline measures included demographic (sex, age, weight, and pubertal status), clinical, and family measures. Clinical variables included baseline illness severity ratings (the Aberrant Behavior Checklist, the Child and Adolescent Symptom Inventory, the Vineland Adaptive Behavior Scales, the Repetitive Behavior Scale-Revised, and the Children's Yale-Brown Obsessive-Compulsive Scale). Family measures included the Caregiver Strain Questionnaire.
RESULTS: Several baseline predictors of response were identified, and a principal component analysis yielded 3 composite measures (disruptive behavior, autism/mood, and caregiver strain) that significantly predicted response at week 12. Specifically, participants in the placebo group were significantly less likely than participants in the citalopram group to respond at week 12 if they entered the study more symptomatic on each of the 3 composite measures, and they were at least 2 times less likely to be responders.
CONCLUSIONS AND RELEVANCE: This analysis suggests strategies that may be useful in anticipating and potentially mitigating the nonspecific response in randomized clinical trials of children and adolescents with autism spectrum disorders.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00086645.
Authors:
Bryan H King; Kimberly Dukes; Craig L Donnelly; Linmarie Sikich; James T McCracken; Lawrence Scahill; Eric Hollander; Joel D Bregman; Evdokia Anagnostou; Fay Robinson; Lisa Sullivan; Deborah Hirtz
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  JAMA pediatrics     Volume:  167     ISSN:  2168-6211     ISO Abbreviation:  JAMA Pediatr     Publication Date:  2013 Nov 
Date Detail:
Created Date:  2013-11-05     Completed Date:  2014-01-28     Revised Date:  2014-08-27    
Medline Journal Info:
Nlm Unique ID:  101589544     Medline TA:  JAMA Pediatr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1045-52     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00086645
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Asperger Syndrome / drug therapy
Child
Child Development Disorders, Pervasive / drug therapy*
Child, Preschool
Citalopram / therapeutic use*
Female
Humans
Male
Placebo Effect
Principal Component Analysis
Serotonin Uptake Inhibitors / therapeutic use*
Treatment Outcome
Grant Support
ID/Acronym/Agency:
U01-HD045023/HD/NICHD NIH HHS; U54 MH066418/MH/NIMH NIH HHS; U54-MH066398/MH/NIMH NIH HHS; U54-MH066418/MH/NIMH NIH HHS; U54-MH066494/MH/NIMH NIH HHS; U54-MH066673/MH/NIMH NIH HHS; U54-MH068172/MH/NIMH NIH HHS
Chemical
Reg. No./Substance:
0/Serotonin Uptake Inhibitors; 0DHU5B8D6V/Citalopram
Comments/Corrections
Comment In:
JAMA Pediatr. 2013 Nov;167(11):1000-1   [PMID:  24061596 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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