AUTHORS ' CONCLUSIONS There is no evidence of effect of SSRIs in children and emerging evidence of harm .
BACKGROUND Autism spectrum disorders ( ASD ) are characterised by abnormalities in social interaction and communication skills , as well as stereotypic behaviours and restricted activities and interests .
Selective serotonin reuptake inhibitors ( SSRIs ) are prescribed for the treatment of conditions often comorbid with ASD such as depression , anxiety and obsessive-compulsive behaviours .
OBJECTIVES To determine if treatment with an SSRI:1 .
improves the core features of autism ( social interaction , communication and behavioural problems);2 .
improves other non-core aspects of behaviour or function such as self-injurious behaviour;3 .
improves the quality of life of adults or children and their carers;4 .
has short- and long-term effects on outcome ; 5 .
causes harm .
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 r and omized controlled trial . SETTING Six academic centers , including Mount Sinai School of Medicine , North Shore-Long Isl and 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 r and omized 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 systematic ally 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 clinical trials.gov Identifier : NCT00086645
AUTHORS ' CONCLUSIONS There is no evidence of effect of SSRIs in children and emerging evidence of harm .
BACKGROUND Autism spectrum disorders ( ASD ) are characterised by abnormalities in social interaction and communication skills , as well as stereotypic behaviours and restricted activities and interests .
Selective serotonin reuptake inhibitors ( SSRIs ) are prescribed for the treatment of conditions often comorbid with ASD such as depression , anxiety and obsessive-compulsive behaviours .
OBJECTIVES To determine if treatment with an SSRI:1 .
improves the core features of autism ( social interaction , communication and behavioural problems);2 .
improves other non-core aspects of behaviour or function such as self-injurious behaviour;3 .
improves the quality of life of adults or children and their carers;4 .
has short- and long-term effects on outcome ; 5 .
causes harm .