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Published Online: 1 February 2018

Simvastatin as an Adjunctive Therapy to Risperidone in Treatment of Autism: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Publication: Journal of Child and Adolescent Psychopharmacology
Volume 28, Issue Number 1


Objectives: Providing novel treatments for autism has been a subject of long-standing research. Based on etiopathological findings, we aim at assessing potential therapeutic effects of statins, here simvastatin, on autism symptoms for the first time.
Methods: In this randomized, double-blind, placebo-controlled, parallel-group 10-week clinical trial, 70 drug-free children aged 4 to 12 years old with diagnosis of autistic disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, who had an Aberrant Behavior Checklist-Community (ABC-C) scale irritability subscale score of ≥12, were equally randomized to receive either simvastatin (20–40 mg/day) or placebo as an adjunct to risperidone (1–2 mg/day) whereas administration of both drugs was started simultaneously from baseline. Patients with comorbid psychiatric disorders, active medical conditions, severe intellectual disability, seizure disorders, history of any treatments for autism in the past 6 months, or history of current anti-inflammatory drug consumption were excluded. Primary outcome was defined as the difference in mean change of the ABC-C scale irritability subscale score from baseline to the endpoint (; IRCT201602041556N86).
Results: Significant differences in change of the ABC-C scale irritability (mean difference [95% confidence interval (CI)] = −3.45 [−5.37 to −1.54], p = 0.001; Cohen's d = 0.89) and hyperactivity/noncompliance (mean difference [95% CI] = −4.27 [−6.69 to −1.86], p = 0.001; Cohen's d = 0.87) subscales scores were detected between the two arms. No significant difference was detected in case of the other three subscales.
Conclusions: This study provides preliminary evidence for potential therapeutic effects of simvastatin in the treatment of autism that warrants further investigations.

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Published In

cover image Journal of Child and Adolescent Psychopharmacology
Journal of Child and Adolescent Psychopharmacology
Volume 28Issue Number 1February 2018
Pages: 82 - 89
PubMed: 28719227


Published in print: February 2018
Published online: 1 February 2018
Published ahead of print: 18 July 2017


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Ehsan Moazen-Zadeh*,
Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Fatemeh Shirzad*
Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Mohammad-Ali Karkhaneh-Yousefi*
Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Rasoul Khezri*
Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Mohammad-Reza Mohammadi
Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Shahin Akhondzadeh
Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.


The first four authors contributed equally in this study.
Contributed also as statistical consultant.
Funding: This study was supported by a grant to Prof. Shahin Akhondzadeh (Grant number 30327) from Tehran University of Medical Sciences (TUMS).
Address correspondence to:Shahin Akhondzadeh, PhDPsychiatric Research CenterRoozbeh Psychiatric HospitalTehran University of Medical SciencesSouth Kargar StreetTehran 13337Iran
E-mail: [email protected]


No competing financial interests exist.

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