Omega-3/Omega-6 Fatty Acids for Attention-Deficit/Hyperactivity Disorder (ADHD): A Trial in Children and Adolescents
Condition: ADHD; Reading/Writing Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective: To assess whether supplementation with Omega 3/6 fatty acids (eye q®) was
      effective in the treatment of ADHD and its diagnostic subtypes and comorbid conditions, in
      children and adolescents.

      Method: Randomized placebo-controlled one-way crossover trial with 75 children and
      adolescents aged 8-18 years receiving Omega 3/6 or placebo for three months followed by 3
      months with Omega 3/6 for all. ADHD symptoms were measured with the investigator-rated ADHD
      Rating Scale-IV-Parent Version and the Clinical Global Impression (CGI) scale of symptom
      severity and impairment.
    

Detailed description: 
      The study design is a randomised, double-blind placebo-controlled trial with a total duration
      of 6 months. 50-100 children and adolescents, aged 8-18 years, who meet the DSM-IVÔ criteria
      for Attention-Deficit/Hyperactivity Disorder (ADHD) of any subtype will be given the
      opportunity to participate. The study comprises 2 study periods.

      Study Period I

      This is an assessment/evaluation and drug washout phase of up to 1-3 months for those
      patients taking any medication excluded by the protocol.

      Study Period II

      Participants will be randomised to 3 months of treatment with a fixed dose of 6 capsules per
      day of EyeQ, divided in two daily doses, to supply 558 mg EPA, 174 mg DHA and 60 mg GLA
      daily, or to placebo. Identical capsules containing olive oil will be used as placebo.
      Randomisation will be organized by Equazen UK Ltd, who will prepare randomisation numbers to
      be sent out to the investigation centre. At 3 months a one-way treatment crossover of the
      placebo-group to active treatment will be made so that both patient groups will receive EyeQ
      for the remaining 3-month period. Compliance will be ascertained through bi-weekly telephone
      contacts and at each visit. Compliance is defined as taking the prescribed dosage >70% of the
      days in a visit interval.

      Neuropsychiatric assessment:

      DSM IV checklist ADHD-Rating Scale IV - Parent:Inv Clinical Global Impression (CGI) scale
      GAF-scale

      FTF teacher questionnaire SNAP-IV teacher questionnaire Brown's ADD teacher scale

      Neuropsychological assessment:

      WISC-III® or WAIS-III® VMI Digit span Span-board task Qb-test

      Brown's ADD self report CDI (Children's Depression Inventory)

      Five to Fifteen (FTF) parent questionnaire Brown's ADD parent scale SNAP-IV parent
      questionnaire Nijmegen questionnaire HUFA deficiency questionnaire

      Reading and writing tests:

      DLS etc
    

Intervention name(s): Omega 3/6 fatty acids; Placebo (olive oil)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 capsules bid orally; 3 capsules bid orally
Other intervention name(s): eyeq
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention-deficit/hyperactivity disorder; Omega 3/6 fatty acids; Developmental coordination disorder; Reading/writing difficulties.