90852
document
Naltrexone in young autistic children : replication study and learning measures . OBJECTIVE This study expanded upon previous work on naltrexone efficacy and safety in young autistic children and assessed performance on learning measures . METHOD Eleven children with autistic disorder , aged 3.0 to 8.3 years , were studied in home , school , and outpatient laboratory , bringing to 24 the combined study sample . Naltrexone , 1.0 mg/kg , was given daily in a randomized , double-blind , crossover design . Dependent measures were parent and teacher Clinical Global Impressions ( CGI ) and Naltrexone Side Effects Rating Scale ( SE ) , Conners Parent Impulsivity/Hyperactivity Factor , Teacher Hyperactivity Factor , laboratory CGI , and analysis of videotaped behavior . Learning measures were the Early Intervention Developmental Profile-Language and paired-associate learning . RESULTS Comparisons between naltrexone and baseline , but not naltrexone and placebo , on parent and teacher ratings showed statistical significance . Three of 11 subjects improved in two or more settings . Side effects were mild . Administering naltrexone was a challenge . The combined study sample showed improvement on all parent measures and on Teacher CGI and SE-Restlessness compared with baseline and placebo . Eleven of the 24 children improved in two or more settings . Scores on learning measures did not change across conditions . CONCLUSIONS Naltrexone was associated with modest improvement of behavior in 11 of 24 children , but learning did not improve .
90853
Intervention_Pharmacological
Naltrexone
90854
Intervention_Pharmacological
naltrexone
90855
Intervention_Pharmacological
Naltrexone
90856
Intervention_Pharmacological
naltrexone
90857
Intervention_Pharmacological
naltrexone
90858
Intervention_Control
placebo
90859
Intervention_Pharmacological
naltrexone
90860
Intervention_Control
placebo
90861
Intervention_Pharmacological
Naltrexone
90862
Outcome_Mental
Clinical Global Impressions ( CGI )
90863
Outcome_Adverse-effects
Naltrexone Side Effects Rating Scale ( SE ) ,
90864
Outcome_Mental
Conners Parent Impulsivity/Hyperactivity Factor
90865
Outcome_Mental
Teacher Hyperactivity Factor
90866
Outcome_Mental
Early Intervention Developmental Profile-Language
90867
Outcome_Other
paired-associate learning
90868
Outcome_Adverse-effects
Side effects
90869
Outcome_Mental
parent measures
90870
Outcome_Mental
Teacher CGI
90871
Outcome_Mental
SE-Restlessness
90872
Outcome_Mental
learning measures
90873
Outcome_Mental
behavior
90874
Outcome_Mental
learning
90875
Participant_Condition
Eleven children with autistic disorder , aged 3.0 to 8.3 years