EFFECT OF 8-WEEK FATTY ACIDS OMEGA-3 TREATMENT ON OXIDATIVE METABOLISM IN PATIENTS WITH AUTISM SPECTRUM DISORDER: A RANDOMISED DOUBLE-BLIND CROSSOVER PLACEBO-CONTROLLED TRIAL.

INTERVENTION: Product Code: EFA‐3 Pharmaceutical Form: Capsule, soft INN or Proposed INN: EFE‐3 Other descriptive name: Acidos Grasos Omega‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 350‐ Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use CONDITION: autism spectrum disorders Trastornos del Espectro Autista ; MedDRA version: 9.1 Level: LLT Classification code 10063844 Term: Autism spectrum disorder PRIMARY OUTCOME: Main Objective: To assess oxidative metabolism status and levels of Poli‐Unsaturated Fatty Acids (PUFAS) in Autism Spectrum Disorder (ASD) patients before and after an 8 week treatment with essential fatty acids omega‐3 (EFA‐3) or placebo (PLO). Primary end point(s): Niveles de estrés oxidativo tras el tratamiento, medido como niveles de PUFAS en membrana de eritrocitos, TAOS y niveles de glutatión en plasma. Secondary Objective: ‐To assess Global Cinical Impression before and after treatment with EFA‐3 or PLO; ‐To assess disruptive behaviours and other related symptoms, measured by ABC, CBCL and SRS before and after treatment with EFA‐3 or PLO; ‐To assess the presence of symtoms or signs of fatty acids deficiency before and after a treatment with EFA‐3 or PLO. INCLUSION CRITERIA: ‐Diagnosis of an Autism Spectrum Disorder. Diagnosed made by fulfilling 2 of the following 3: DSM‐IV criteria for any of the Pervasive Developmental Disorders (except for Asperger Syndrome in which case Gillberg criteria substitute DSM‐IV criteria), ADOS interview and clinical judgement. ‐Age at recruitment between 5 and 17 ‐Written consent form signed by a parent or legal representative and minor (if over 12 and capable to give consent) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range