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Divalproex sodium vs placebo for the treatment of irritability in children and adolescents with autism spectrum disorders . Autism spectrum disorders ( ASDs ) are neurodevelopmental disorders characterized by social and language deficits and by repetitive behaviors and interests . Irritability/aggression is a significant comorbid symptom in this population , which greatly impacts burden of care . This study examined the effect of divalproex sodium for irritability/aggression in children and adolescents with ASD . This was a 12-week randomized , double-blind , placebo-controlled trial . All efficacy measures were obtained by an independent evaluator blinded to randomization condition and side effects . A total of 55 subjects gavetheir consent and 27 were randomized in a 1 : 1 manner ( mean age 9.46+/-2.46 , mean nonverbal IQ 63.3+/-23.9 ) . Two subjects from the active group and one subject from the placebo group discontinued the study because of either a lack of efficacy or side effects ( increased irritability ) . Primary outcome measures were Aberrant Behavior Checklist-Irritability subscale and Clinical Global Impression-Improvement , which focused on irritability . Overall , 62.5 % of divalproex subjects vs 9 % of placebo subjects were responders ( CGI-irritability OR : 16.7 , Fisher 's exact p=0.008 ) . A statistically significant improvement was also noted on the ABC-Irritability subscale ( p=0.048 ) . There was a trend for responders to have higher valproate blood levels compared with nonresponders . This study suggests the efficacy of divalproex for the treatment of irritability in children and adolescents with ASD . Larger sample follow-up studies are warranted .
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Intervention_Pharmacological
Divalproex sodium
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Intervention_Control
placebo
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Intervention_Pharmacological
divalproex sodium
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Intervention_Control
placebo-controlled
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Intervention_Control
placebo
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Intervention_Pharmacological
divalproex
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Intervention_Control
placebo
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Intervention_Pharmacological
divalproex
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Outcome_Mental
irritability
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Outcome_Other
efficacy
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Outcome_Adverse-effects
side effects
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Outcome_Mental
Aberrant Behavior Checklist-Irritability subscale and Clinical Global Impression-Improvement
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Outcome_Mental
responders
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Outcome_Mental
ABC-Irritability subscale
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Outcome_Physical
valproate blood levels
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Outcome_Other
efficacy
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Outcome_Mental
irritability
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Participant_Age
children
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Participant_Age
adolescents
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Participant_Condition
autism spectrum disorders
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Participant_Age
children
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Participant_Age
adolescents
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Participant_Condition
ASD
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Participant_Sample-size
55
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Participant_Sample-size
27
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Participant_Age
9.46+/-2.46