autism spectrum disorders Trastornos del Espectro Autista MedDRA version: 9.1 Level: LLT Classification code 10063844 Term: Autism spectrum disorder
Conditions
Interventions
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
Concentrat
Sponsors
Fundación para la Investigación Biomédica Hospital Gregorio Marañón
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: -Other pscyhiatric diagnosis of Axis I -Drug abuse/dependence -Medical contraindication for the ingestion of fatty acids or vitamin E -Treatment with anticoagulants -Treatment with nutritional supplements -Treatment with antipsychotics -Concomitant structured psychotherapeutic treatment -Medical conditions that affect oxidative metabolism or for which the patients are taking drugs that affect oxidative metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).;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.;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. | — |
Countries
Spain
Outcome results
None listed