title: Minocycline as Adjunctive Treatment to Risperidone in Children with Autistic Disorder: A Randomized, Double-Blind Placebo-Controlled Trial.
abstract: This is an investigation of minocycline efficacy and safety as an adjuvant to risperidone in management of children with autism.
  
  
  
  Forty-six children with diagnosis of autistic disorder, according to the Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) criteria and a score of ≥12 on the Aberrant Behavior Checklist-Community (ABC-C) irritability subscale, who were already drug-free for at least 6 months participated in a randomized controlled trial and underwent 10 weeks of treatment with either minocycline (50 mg twice per day) or placebo in addition to risperidone titrated up to 2 mg/day (based on bodyweight). Patients were evaluated using ABC-C at baseline and at weeks 5 and 10.
  
  
  
  General linear model repeated measures showed significant effect for time × treatment interaction on the irritability [F(2, 88) = 3.94, p = 0.02] and hyperactivity/noncompliance [F(1.50, 66.05) = 7.92, p = 0.002], but not for lethargy/social withdrawal [F(1.61, 71.02) = 0.98, p = 0.36], stereotypic behavior [F(1.34, 58.80) = 1.55, p = 0.22], and inappropriate speech subscale scores [F(1.52, 66.88) = 1.15, p = 0.31]. By week 10, 21 (91.3%) patients in the minocycline group and 15 (65.5%) patients in the placebo group achieved at least partial response (p = 0.03). Frequencies of adverse events were not significantly different between groups.
  
  
  
  Minocycline seems to be a safe and effective adjuvant in management of patients with autistic disorder. Future studies with larger sample sizes, longer follow-ups, and inflammatory cytokine measurements are warranted to confirm these findings and provide insight into minocycline mechanism of action in autistic disorder.
authors.affiliation: 1 Behavioral Disorders and Substance Abuse Research Center, Hamadan University of Medical Sciences , Hamadan, Iran .
authors.forename: Ali
authors.initials: A
authors.lastname: Ghaleiha
authors.affiliation: 2 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran .
authors.forename: Rosa
authors.initials: R
authors.lastname: Alikhani
authors.affiliation: 3 Department of Psychiatry, AJA University of Medical Sciences , Tehran, Iran .
authors.forename: Mohammad-Reza
authors.initials: MR
authors.lastname: Kazemi
authors.affiliation: 2 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran .
authors.forename: Mohammad-Reza
authors.initials: MR
authors.lastname: Mohammadi
authors.affiliation: 2 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran .
authors.forename: Payam
authors.initials: P
authors.lastname: Mohammadinejad
authors.affiliation: 2 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran .
authors.forename: Atefeh
authors.initials: A
authors.lastname: Zeinoddini
authors.affiliation: 2 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran .
authors.forename: Mehdi
authors.initials: M
authors.lastname: Hamedi
authors.affiliation: 2 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran .
authors.forename: Mona
authors.initials: M
authors.lastname: Shahriari
authors.affiliation: 1 Behavioral Disorders and Substance Abuse Research Center, Hamadan University of Medical Sciences , Hamadan, Iran .
authors.forename: Zahra
authors.initials: Z
authors.lastname: Keshavarzi
authors.affiliation: 1 Behavioral Disorders and Substance Abuse Research Center, Hamadan University of Medical Sciences , Hamadan, Iran .
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
mesh_terms: D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001321:Autistic Disorder / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007508:Irritable Mood / Q000187:drug effects; D016014:Linear Models; D008297:Male; D008911:Minocycline / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D018967:Risperidone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D008911:Minocycline; D018967:Risperidone
keywords: autistic disorder; glutamate; minocycline