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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219309
• Other study ID #: Ö761-03
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2010
• Last updated: October 12, 2010
• Start date: August 2004
• Est. completion date: April 2007

Study information

• Verified date: April 2010
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Committee Göteborg Sweden:
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Reading/Writing Disorder

Intervention

Dietary Supplement:
• Omega 3/6 fatty acids
3 capsules bid orally
• Placebo (olive oil)
3 capsules bid orally

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vifor Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Clinical Global Impression-Severity Scale	Investigator-rated global impression of ADHD symptom severity	From 0-3 months	No
Secondary	Clinical Global Impression-Severity Scale	Investigator-rated global impression of ADHD symptom severity	From 3-6 months	No