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document
Cyproheptadine in the treatment of autistic disorder : a double-blind placebo-controlled trial . OBJECTIVE Autism is a childhood-onset disorder of unknown , possibly of multiple aetiologies . The core symptoms of autism are abnormalities in social interaction , communication and behaviour . The involvement of neurotransmitters such as 5-HT has been suggested in neuropsychiatric disorders and particularly in autistic disorder . Increased platelet 5-HT levels were found in 40 % of the autistic population , suggesting that hyperserotonaemia may be a pathologic factor in infantile autism . Therefore , it is of interest to assess the efficacy of cyproheptadine , a 5-HT2 antagonist in the treatment of autistic disorder . In this 8-week double-blind , placebo-controlled trial , we assessed the effects of cyproheptadine plus haloperidol in the treatment of autistic disorder . METHODS Children between the ages 3 and 11 years ( inclusive ) with a DSM IV clinical diagnosis of autism and who were outpatients from a specialty clinic for children at Roozbeh Psychiatric Teaching Hospital were recruited . The children presented with a chief complaint of severely disruptive symptoms related to autistic disorder . Patients were randomly allocated to cyproheptadine + haloperidol ( Group A ) or haloperidol + placebo ( Group B ) for an 8-week , double-blind , placebo-controlled study . The dose of haloperidol and cyproheptadine was titrated up to 0.05 and 0.2 mg/kg/day respectively . Patients were assessed by a third-year resident of psychiatry at baseline and after 2 , 4 , 6 and 8 weeks of starting medication . The primary measure of the outcome was the Aberrant Behaviour Checklist-Community ( ABC-C ) and the secondary measure of the outcome was the Childhood Autism Rating Scale ( relating to people and verbal communication ) . Side effects and extrapyramidal symptoms were systematically recorded throughout the study and were assessed using a checklist and the Extrapyramidal Symptoms Rating Scale , administered by a resident of psychiatry during weeks 1 , 2 , 4 , 6 and 8 . RESULTS The ABC-C and the Childhood Autism Rating Scale scores improved with cyproheptadine . The behaviour of the two treatments was not homogeneous across time ( groups-by-time interaction , Greenhouse-Geisser correction ; F = 7.30 , d.f . = 1.68 , P = 0.002 ; F = 8.21 , d.f . = 1.19 , P = 0.004 respectively ) . The difference between the two treatments was significant as indicated by the effect of group , and the between-subjects factor ( F = 4.17 , d.f . = 1 , P = 0.048 ; F = 4.29 , d.f . = 1 , P = 0.045 respectively ) . No significant difference was observed between the two groups in terms of extrapyramidal symptoms ( P = 0.23 ) . The difference between the two groups in the frequency of side effects was not significant . CONCLUSION The results suggest that the combination of cyproheptadine with a conventional antipsychotic may be superior to conventional antipsychotic alone for children with autistic disorder . However the results need confirmation by a larger randomized controlled trial .
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Intervention_Pharmacological
Cyproheptadine
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
cyproheptadine
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Intervention_Pharmacological
5-HT2 antagonist
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
cyproheptadine plus haloperidol
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Intervention_Pharmacological
cyproheptadine + haloperidol
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Intervention_Physical
haloperidol
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Intervention_Control
+ placebo
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Intervention_Pharmacological
haloperidol and cyproheptadine
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Intervention_Pharmacological
cyproheptadine
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Intervention_Pharmacological
cyproheptadine
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Intervention_Pharmacological
conventional antipsychotic
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Intervention_Control
conventional antipsychotic alone
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Outcome_Mental
Aberrant Behaviour Checklist-Community ( ABC-C
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Outcome_Mental
Childhood Autism Rating Scale ( relating to people and verbal communication
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Outcome_Mental
ABC-C and the Childhood Autism Rating Scale scores
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Outcome_Physical
extrapyramidal symptoms
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Outcome_Adverse-effects
frequency of side effects
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Participant_Condition
autistic disorder :
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Participant_Condition
infantile autism
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Participant_Age
Children between the ages 3 and 11 years
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Participant_Condition
DSM IV clinical diagnosis of autism
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Participant_Condition
outpatients
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Participant_Age
children
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Participant_Condition
autistic disorder
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Participant_Age
children
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Participant_Condition
autistic disorder