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. - Omega-3 tr

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10063844Term: Autism spectrum disorder; autism spectrum disordersTrastornos del Espectro Autista

• Registration Number: EUCTR2007-006444-21-ES
• Lead Sponsor: Fundación para la Investigación Biomédica Hospital Gregorio Marañón

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-01
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified