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Trial record 37 of 1522 for:    child psychiatry

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01219309
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : October 13, 2010
Vifor Pharma
Information provided by:
Göteborg University

Brief 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.

Condition or disease Intervention/treatment Phase
ADHD Reading/Writing Disorder Dietary Supplement: Omega 3/6 fatty acids Dietary Supplement: Placebo (olive oil) Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega-3/Omega-6 Fatty Acids for ADHD. A Randomized Placebo-controlled Trial in Children and Adolescents
Study Start Date : August 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Omega 3/6 treatment Dietary Supplement: Omega 3/6 fatty acids
3 capsules bid orally
Other Name: eyeq

Placebo Comparator: Placebo Dietary Supplement: Placebo (olive oil)
3 capsules bid orally

Primary Outcome Measures :
  1. ADHD-Rating Scale, Investigator-rated [ Time Frame: From 0-3 months ]
    The scale comprises the 18 DSM-IV items included in the ADHD diagnosis, and each item is assessed on a 0-3 point scale

  2. ADHD-Rating Scale, Investigator-rated [ Time Frame: From 3-6 months ]
    The scale comprises the 18 DSM-IV items included in the ADHD diagnosis, and each item is assessed on a 0-3 point scale

Secondary Outcome Measures :
  1. Clinical Global Impression-Severity Scale [ Time Frame: From 0-3 months ]
    Investigator-rated global impression of ADHD symptom severity

  2. Clinical Global Impression-Severity Scale [ Time Frame: From 3-6 months ]
    Investigator-rated global impression of ADHD symptom severity

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01219309

Sponsors and Collaborators
Göteborg University
Vifor Pharma
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Principal Investigator: Mats Johnson, MD Göteborg University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mats Johnson, Department of Child Psychiatry, Göteborg University Identifier: NCT01219309     History of Changes
Other Study ID Numbers: Ö761-03
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: April 2010
Keywords provided by Göteborg University:
Attention-deficit/hyperactivity disorder
Omega 3/6 fatty acids
Developmental coordination disorder
Reading/writing difficulties.
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders