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document
A double-blind , placebo-controlled study of valproate for aggression in youth with pervasive developmental disorders . OBJECTIVE The aim of this study was to study valproate efficacy and safety for aggression in children and adolescents with pervasive developmental disorders ( PDD ) . METHODS In this prospective double-blind , placebo-controlled study , 30 subjects ( 20 boys , 10 girls ) 6-20 years of age with PDD and significant aggression were randomized and received treatment with valproate ( VPA ) or placebo ( PBO ) for 8 weeks as outpatients . Mean VPA trough blood levels were 75.5 mcg/mL at week 4 and 77.8 mcg/mL at week 8 . RESULTS No treatment difference was observed statistically between VPA and PBO groups . The Aberrant Behavior Checklist -- Community Scale ( ABC-C ) Irritability subscale was the primary outcome measure ( p = 0.65 ) , and CGI -- Improvement ( p = 0.16 ) and OAS ( p = 0.96 ) were secondary outcome measures . Increased appetite and skin rash were significant side effects . Only 1 subject was dropped from the study owing to side effects , notably a spreading skin rash , which then resolved spontaneously . Two subjects receiving VPA developed increased serum ammonia levels , one with an associated parent report of slurred speech and mild cognitive slowing . Poststudy , of 16 VPA and PBO subjects receiving VPA , 10 subjects demonstrated sustained response , 4 of whom later attempted taper , with significant relapse of aggression . CONCLUSION The present negative findings can not be viewed as conclusive , partly owing to the large placebo response , subject heterogeneity , and size of the groups . Larger studies are needed to expand upon these findings .
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
valproate
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Intervention_Pharmacological
valproate
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
valproate ( VPA )
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Intervention_Control
placebo
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Intervention_Pharmacological
( PBO )
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Intervention_Pharmacological
VPA
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Intervention_Pharmacological
PBO
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Intervention_Pharmacological
VPA
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Intervention_Pharmacological
VPA
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Intervention_Pharmacological
PBO
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Intervention_Pharmacological
VPA
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Intervention_Control
placebo
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Outcome_Physical
Mean VPA trough blood levels
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Outcome_Mental
Aberrant Behavior Checklist -- Community Scale ( ABC-C ) Irritability subscale
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Outcome_Mental
CGI -- Improvement
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Outcome_Mental
OAS
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Outcome_Adverse-effects
Increased appetite and skin rash
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Outcome_Adverse-effects
spreading skin rash
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Outcome_Adverse-effects
serum ammonia levels
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Outcome_Mental
slurred speech and mild cognitive slowing
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Outcome_Mental
relapse of aggression