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

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

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.

Study Overview

• Status: Completed
• Conditions: ADHD; Reading/Writing Disorder
• Intervention / Treatment: Dietary supplement: Omega 3/6 fatty acids; Dietary supplement: Placebo (olive oil)

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

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo (olive oil); 3 capsules bid orally
Active Comparator: Omega 3/6 treatment	Dietary supplement: Omega 3/6 fatty acids; 3 capsules bid orally; Other Names: eyeq

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Vifor Pharma
• Investigators: Principal Investigator: Mats Johnson, MD, Göteborg University

Publications and helpful links

General Publications

• Johnson M, Mansson JE, Ostlund S, Fransson G, Areskoug B, Hjalmarsson K, Landgren M, Kadesjo B, Gillberg C. Fatty acids in ADHD: plasma profiles in a placebo-controlled study of Omega 3/6 fatty acids in children and adolescents. Atten Defic Hyperact Disord. 2012 Dec;4(4):199-204. doi: 10.1007/s12402-012-0084-4. Epub 2012 Jul 3.

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: April 29, 2010
• First Submitted That Met QC Criteria: October 12, 2010
• First Posted (Estimate): October 13, 2010

Study Record Updates

• Last Update Posted (Estimate): October 13, 2010
• Last Update Submitted That Met QC Criteria: October 12, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Attention-deficit/hyperactivity disorder; Omega 3/6 fatty acids; Developmental coordination disorder; Reading/writing difficulties.
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: Ö761-03