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Risperidone Combination Therapy With Propentofylline for Treatment of Irritability in Autism Spectrum Disorders

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Behmanesh, Helen MD; Moghaddam, Hossein Sanjari MD; Mohammadi, Mohammad-Reza MD; Akhondzadeh, Shahin PhD

doi: 10.1097/WNF.0000000000000368
Original Articles
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Objectives Propentofylline is a xanthine phosphodiesterase inhibitor and adenosine reuptake blocker with neuroprotective effects linked to anti-inflammatory and antiexcitatory properties. This is a double-blind, placebo-controlled trial investigating the potential beneficial effects of propentofylline, as an adjunctive treatment with risperidone, on the severity and behavioral abnormalities of autism spectrum disorder (ASD).

Methods A total of 48 children with ASD were randomly allocated into 2 groups of risperidone (initiating at 0.5 mg/d) plus propentofylline (initiating at 300 mg/d) and risperidone plus placebo. The Aberrant Behavior Checklist—Community (ABC-C) and Childhood Autism Rating Scale (CARS) were used for the evaluation of ASD severity and behavioral disruptions at baseline, week 4, and week 10. Primary outcome measure of the study was ABC-C irritability subscale score, whereas CARS score along with other 4 subscales of ABC-C (lethargy/social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech subscales) were considered as secondary outcome measures.

Results Results from the general linear model repeated measures analysis demonstrated significant time-treatment interaction on irritability subscale (F1.55 = 3.45; P = 0.048) and CARS (F1.41 = 4.08; P = 0.034) scores. Compared with the placebo group, children receiving propentofylline showed greater improvements in the CARS score (P = 0.037) from baseline to the study endpoint. Our results found no significant time-treatment effect on other subscales of ABC-C. Two trial groups were comparable based on the frequency of adverse effects.

Conclusions Our findings demonstrated that adjunctive treatment with propentofylline is effective in alleviating disease severity and improving irritability in ASD patients. However, larger studies with longer durations are required to confirm these results.

Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.

Address correspondence and reprint requests to Shahin Akhondzadeh, PhD, Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar St, Tehran 13337, Iran; E-mail: s.akhond@neda.net

Conflicts of Interest and Source of Funding: This study was supported by a grant from Tehran University of Medical Sciences to Prof Shahin Akhondzadeh (grant number 3899). The authors have no conflict of interest to disclose.

H.B. and H.S.M. contributed equally in this study.

The registration code for this trial at the Iranian Registry of Clinical Trials is IRCT20090117001556N113 (www.irct.ir).

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