40485
document
Lack of efficacy of citalopram in children with autism spectrum disorders and high levels of repetitive behavior : citalopram ineffective in children with autism . CONTEXT Selective serotonin reuptake inhibitors are widely prescribed for children with autism spectrum disorders . OBJECTIVES To determine the efficacy and safety of citalopram hydrobromide therapy for repetitive behavior in children with autism spectrum disorders . DESIGN National Institutes of Health-sponsored randomized controlled trial . SETTING Six academic centers , including Mount Sinai School of Medicine , North Shore-Long Island Jewish Health System , University of North Carolina at Chapel Hill , University of California at Los Angeles , Yale University , and Dartmouth Medical School . PARTICIPANTS One hundred forty-nine volunteers 5 to 17 years old ( mean [ SD ] age , 9.4 [ 3.1 ] years ) were randomized to receive citalopram ( n = 73 ) or placebo ( n = 76 ) . Participants had autistic spectrum disorders , Asperger disorder , or pervasive developmental disorder , not otherwise specified ; had illness severity ratings of at least moderate on the Clinical Global Impressions , Severity of Illness Scale ; and scored at least moderate on compulsive behaviors measured with the Children 's Yale-Brown Obsessive Compulsive Scales modified for pervasive developmental disorders . INTERVENTIONS Twelve weeks of citalopram hydrobromide ( 10 mg/5 mL ) or placebo . The mean ( SD ) maximum dosage of citalopram hydrobromide was 16.5 ( 6.5 ) mg/d by mouth ( maximum , 20 mg/d ) . MAIN OUTCOME MEASURES Positive response was defined by a score of much improved or very much improved on the Clinical Global Impressions , Improvement subscale . An important secondary outcome was the score on the Children 's Yale-Brown Obsessive Compulsive Scales modified for pervasive developmental disorders . Adverse events were systematically elicited using the Safety Monitoring Uniform Report Form . RESULTS There was no significant difference in the rate of positive response on the Clinical Global Impressions , Improvement subscale between the citalopram-treated group ( 32.9 % ) and the placebo group ( 34.2 % ) ( relative risk , 0.96 ; 95 % confidence interval , 0.61-1.51 ; P > .99 ) . There was no difference in score reduction on the Children 's Yale-Brown Obsessive Compulsive Scales modified for pervasive developmental disorders from baseline ( mean [ SD ] , -2.0 [ 3.4 ] points for the citalopram-treated group and -1.9 [ 2.5 ] points for the placebo group ; P = .81 ) . Citalopram use was significantly more likely to be associated with adverse events , particularly increased energy level , impulsiveness , decreased concentration , hyperactivity , stereotypy , diarrhea , insomnia , and dry skin or pruritus . CONCLUSION Results of this trial do not support the use of citalopram for the treatment of repetitive behavior in children and adolescents with autism spectrum disorders . Trial Registration clinicaltrials.gov Identifier : NCT00086645 .
40486
Intervention_Pharmacological
citalopram
40487
Intervention_Pharmacological
citalopram
40488
Intervention_Pharmacological
Selective serotonin reuptake inhibitors
40489
Intervention_Pharmacological
citalopram hydrobromide therapy
40490
Intervention_Pharmacological
citalopram
40491
Intervention_Control
placebo
40492
Intervention_Pharmacological
citalopram hydrobromide
40493
Intervention_Control
placebo
40494
Intervention_Pharmacological
citalopram hydrobromide
40495
Intervention_Pharmacological
citalopram-treated
40496
Intervention_Control
placebo
40497
Intervention_Pharmacological
citalopram-treated
40498
Intervention_Control
placebo
40499
Intervention_Pharmacological
Citalopram
40500
Intervention_Pharmacological
citalopram
40501
Outcome_Other
efficacy
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Outcome_Mental
Clinical Global Impressions , Improvement subscale .
40503
Outcome_Mental
Children 's Yale-Brown Obsessive Compulsive Scales modified for pervasive developmental disorders .
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Outcome_Adverse-effects
Adverse events
40505
Outcome_Mental
Children 's Yale-Brown Obsessive Compulsive Scales
40506
Outcome_Mental
developmental disorders
40507
Outcome_Adverse-effects
energy level , impulsiveness
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Outcome_Adverse-effects
concentration , hyperactivity , stereotypy , diarrhea , insomnia , and dry skin or pruritus .
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Participant_Condition
children with autism spectrum disorders and high levels of repetitive behavior :
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Participant_Age
children with autism .
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Participant_Age
children with autism spectrum disorders .