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Palmitoylethanolamide as adjunctive therapy for autism: Efficacy and safety results from a randomized controlled trial

Khalaj M, Saghazadeh A, Shirazi E, Shalbafan MR, Alavi K, Shooshtari MH, Laksari FY, Hosseini M, Mohammadi MR, Akhondzadeh S. Journal of Psychiatric Research, 2018; 103:104-111.

Randomised controlled trialHumans

Design
Randomised controlled trial
Subjects
70 children aged 4 to 12 with autism and moderate to severe irritability
Dose used in the study
Palmitoylethanolamide added to the antipsychotic risperidone. The comparison group took placebo with risperidone. The dose was not visible on the page checked.
Duration
10 weeks
What was measured
The Aberrant Behavior Checklist, which rates irritability, hyperactivity, inappropriate speech, social withdrawal and repetitive behaviour

What the authors reported

The authors reported a larger improvement in irritability and in hyperactivity in the palmitoylethanolamide group than with risperidone alone (p = 0.001). The difference for inappropriate speech fell just short of significance (p = 0.051). They found no significant difference for social withdrawal or repetitive behaviour.

Limits of this study

All children also took risperidone, so the trial tested palmitoylethanolamide as an add-on, not alone. The study was in children, and nothing in it bears on unsupervised use. Adverse events and limitations were not visible on the page checked. It was funded by a grant from Tehran University of Medical Sciences.

Source

doi:10.1016/j.jpsychires.2018.04.022

Entry checked against the abstract page at the publisher (ScienceDirect) on 2026-09-21. The dose shown is the dose the researchers used. It is not a recommendation. How to read this page.