title: A double-blind placebo controlled trial of piracetam added to risperidone in patients with autistic disorder.
abstract: It has been reported that autism is a hypoglutamatergic disorder. Therefore, it was of interest to assess the efficacy of piracetam, a positive modulator of AMPA-sensitive glutamate receptors in autistic disorder. About 40 children between the ages three and 11 years (inclusive) with a DSM IV clinical diagnosis of autism and who were outpatients from a specialty clinic for children were recruited. The children presented with a chief complaint of severely disruptive symptoms related to autistic disorder. Patients were randomly allocated to piracetam + risperidone (Group A) or placebo + risperidone (Group B) for a 10-week, double-blind, placebo-controlled study. The dose of risperidone was titrated up to 2 mg/day for children between 10 and 40 kg and 3 mg/day for children weighting above 40 kg. The dose of piracetam was titrated up to 800 mg/day. Patients were assessed at baseline and after 2, 4, 6, 8 and 10 weeks of starting medication. The measure of the outcome was the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale (total score). The ABC-C Rating Scale scores improved with piracetam. The difference between the two protocols was significant as indicated by the effect of group, the between subjects factor (F = 5.85, d.f. = 1, P = 0.02). The changes at the endpoint compared with baseline were: -11.90 +/- 3.79 (mean +/- SD) and -5.15 +/- 3.04 for group A and B respectively. A significant difference was observed on the change in scores in the ABC-C Rating Scale in week 10 compared with baseline in the two groups (t = 6.017, d.f. = 38, P < 0.0001). The results suggest that a combination of atypical antipsychotic medications and a glutamate agent such as piracetam, might have increase synergistic effects in the treatment of autism.
authors.affiliation: Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran, 13337, Iran. s.akhond@neda.net
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
authors.forename: Hamid
authors.initials: H
authors.lastname: Tajdar
authors.forename: Mohammad-Reza
authors.initials: MR
authors.lastname: Mohammadi
authors.forename: Mohammad
authors.initials: M
authors.lastname: Mohammadi
authors.forename: Gholam-Hossein
authors.initials: GH
authors.lastname: Nouroozinejad
authors.forename: Omid L
authors.initials: OL
authors.lastname: Shabstari
authors.forename: Hossein-Ali
authors.initials: HA
authors.lastname: Ghelichnia
mesh_terms: D014150:Antipsychotic Agents / Q000494:pharmacology* / Q000627:therapeutic use*; D001321:Autistic Disorder / Q000523:psychology*; D002648:Child; D002675:Child, Preschool; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D018696:Neuroprotective Agents / Q000494:pharmacology* / Q000627:therapeutic use*; D010889:Piracetam / Q000494:pharmacology* / Q000627:therapeutic use*; D011595:Psychomotor Agitation / Q000188:drug therapy* / Q000209:etiology*; D018091:Receptors, AMPA / Q000187:drug effects; D018967:Risperidone / Q000494:pharmacology* / Q000627:therapeutic use*; D011795:Surveys and Questionnaires
chemical_list: D014150:Antipsychotic Agents; D018696:Neuroprotective Agents; D018091:Receptors, AMPA; D018967:Risperidone; D010889:Piracetam