55848
document
Celecoxib as adjunctive treatment to risperidone in children with autistic disorder : a randomized , double-blind , placebo-controlled trial . RATIONAL Autism is associated with activation of the inflammatory response system . OBJECTIVE This study aims to assess the efficacy of a cyclooxygenase-2 inhibitor , celecoxib , as adjunctive therapy in the treatment of autism METHODS In a 10-week randomized double-blind placebo-controlled study , 40 outpatient children with a Diagnostic and Statistical Manual of Mental Disorders , fourth edition , text revision clinical diagnosis of autism were randomly allocated to celecoxib plus risperidone or placebo plus risperidone . The dose of risperidone and celecoxib were titrated up to 3 and 300 mg/day , respectively . Patients were assessed at baseline and after 2 , 4 , 6 , and 10 weeks of starting medication using the Aberrant Behavior Checklist-Community ( ABC-C ) Rating Scale . Primary outcome measure was the change in irritability subscale of ABC-C . RESULTS Significant time × treatment interaction was observed for Irritability ( F ( 1.658 , 63.021 ) = 13.580 , P < 0.001 ) , Lethargy/Social Withdrawal ( F ( 1.948 , 74.032 ) = 16.811 , P < 0.001 ) , and Stereotypic Behavior ( F ( 1.742 , 66.198 ) = 12.104 , P < 0.001 ) , but not for Hyperactivity/Noncompliance ( F ( 2.564 , 97.424 ) = 1.469 , P = 0.232 ) , and Inappropriate Speech subscales ( F ( 1.607 , 61.075 ) = 0.173 , P = 0.794 ) . By week 10 , patients in the celecoxib group showed significantly greater improvement in the Irritability ( P < 0.001 ) , Lethargy/Social Withdrawal ( P < 0.001 ) , and Stereotypic Behavior ( P < 0.00 ) but not in Hyperactivity/Noncompliance ( P = 0.202 ) and Inappropriate Speech ( P = 0.802 ) subscales than the placebo group . Complete response was achieved by four ( 20 % ) patients in the placebo group and 11 ( 55 % ) patients in the celecoxib group ( χ ( 2 ) ( 1 ) = 5.227 , P = 0.022 ) . Frequency of side effects was similar between the two groups . CONCLUSIONS Combination of risperidone and celecoxib was superior to risperidone alone in treating irritability , social withdrawal , and stereotypy of children with autism . ( Registration , www.irct.ir ; IRCT138711091556N2 ) .
55849
Intervention_Pharmacological
Celecoxib
55850
Intervention_Pharmacological
risperidone
55851
Intervention_Pharmacological
cyclooxygenase-2 inhibitor , celecoxib
55852
Intervention_Pharmacological
celecoxib plus risperidone
55853
Intervention_Control
placebo plus risperidone
55854
Intervention_Pharmacological
risperidone
55855
Intervention_Pharmacological
celecoxib
55856
Outcome_Other
efficacy
55857
Outcome_Mental
Aberrant Behavior Checklist-Community ( ABC-C ) Rating Scale .
55858
Outcome_Mental
change in irritability subscale of ABC-C .
55859
Participant_Condition
children with autistic disorder :
55860
Participant_Sample-size
40 outpatient children
55861
Participant_Condition
risperidone alone in treating