Omega-3/Omega-6 Fatty Acids for Attention-Deficit/Hyperactivity Disorder (ADHD): A Trial in Children and Adolescents

Study Overview
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Brief Summary
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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
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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

Official Title
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Omega-3/Omega-6 Fatty Acids for ADHD. A Randomized Placebo-controlled Trial in Children and Adolescents

Conditions
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ADHD, Reading/Writing Disorder

Intervention / Treatment
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* Dietary Supplement: Omega 3/6 fatty acids
* Dietary Supplement: Placebo (olive oil)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 8-18 years Met DSM-IV criteria for a diagnosis of ADHD of any subtype Exclusion Criteria: Autism Psychosis Bipolar disorder Mental retardation Uncontrolled seizure disorder Hyper- or hypothyroidism Significant other medical conditions Weight below 20 kg Alcohol or drug abuse or the use in the past three months of any psychoactive drugs or Omega 3 preparations

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega 3/6 treatment<br> | Dietary Supplement: Omega 3/6 fatty acids<br>* 3 capsules bid orally<br>* Other names: eyeq;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo (olive oil)<br>* 3 capsules bid orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD-Rating Scale, Investigator-rated | The scale comprises the 18 DSM-IV items included in the ADHD diagnosis, and each item is assessed on a 0-3 point scale | From 0-3 months | 
| ADHD-Rating Scale, Investigator-rated | The scale comprises the 18 DSM-IV items included in the ADHD diagnosis, and each item is assessed on a 0-3 point scale | From 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression-Severity Scale | Investigator-rated global impression of ADHD symptom severity | From 0-3 months | 
| Clinical Global Impression-Severity Scale | Investigator-rated global impression of ADHD symptom severity | From 3-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention-deficit/hyperactivity disorder, Omega 3/6 fatty acids, Developmental coordination disorder, Reading/writing difficulties.