Neuropediatrics 2005; 36 - P26
DOI: 10.1055/s-2005-868011

Children with autism: A pilot treatment trial with fishoil EPA/DHA. Evaluation of symptom change and changes in PUFAs after supplementation – a randomised double blind, placebo-controlled pilot study

C Klier 1, P Amminger 1, M Hollmann 1, M Schlöglhofer 1, M Feucht 2
  • 1Univ Klinik für Neuropsychiatrie des Kindes- und Jugendalters, Wien
  • 2Univ Klinik für Neuropsychiatrie des Kindes- und Jugendalters und Univ Klinik für Kinder- und Jugendheilkunde, Wien

Objectives: The principal aim is to investigate the effects of 1g/day EPA/DHA in addition to existing psychological and pharmacological therapy in individuals aged 5–17 years with autism on behaviour and lipid status.

Material and Methods: Patients were all recruited from a center which actually treats 120 children and adolescents with autism. All subjects were diagnosed by a specialist using the Autism Diagnostic Interview-Revised (ADI-R) (Poustka et al., 1996). For the dimensional assessment of psychiatric symptoms the Aberrant Behavior Checklist (ABC) (Krug et al., 1980) and the Clinical Global Impression Scale (CGI-S) were used.

We started with a pilot phase including 20 children using a 12 weeks, prospective, double blind, placebo controlled, single center, randomized cross-over study design.

Statistical Analyses

A clinical relevant outcome is the reduction of the ABC irritability score of >35%. (see McCracken et al. 2002). A lower ABC irritability score means lesser behavior symptoms. Also a significant increase in GCI during the time of administration of the verum would show an improvement of the overall functioning. The Topical Niacin Flush Test was performed at baseline and after twelve weeks (developed by Pauline Ward, Highland Psychiatric Research Group, modified assessment score sheet by Dr Gregor Berger, Documentation with high-resolution digital camera for blind rating).

Results: Results of the Niacin Test were negative. Results of the pilot study are positive, which means a decrease of >35% of the ABC irritability score according to the ABC ratings by parents, teachers and professionals or a significant increase on the GCI during the 6 weeks of verum supplementation.

Conclusions: We aim to proceed with a 3 months prospective, double blind, placebo controlled, single center, randomized study including 25 children in each cell.