Trial record 5 of 14 for:    Developmental Dyspraxia

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

This study has been completed.
Sponsor:
Collaborator:
Vifor Pharma
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT01219309
First received: April 29, 2010
Last updated: October 12, 2010
Last verified: April 2010
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • ADHD-Rating Scale, Investigator-rated [ Time Frame: From 0-3 months ] [ Designated as safety issue: No ]
    The scale comprises the 18 DSM-IV items included in the ADHD diagnosis, and each item is assessed on a 0-3 point scale

  • ADHD-Rating Scale, Investigator-rated [ Time Frame: From 3-6 months ] [ Designated as safety issue: No ]
    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:
  • Clinical Global Impression-Severity Scale [ Time Frame: From 0-3 months ] [ Designated as safety issue: No ]
    Investigator-rated global impression of ADHD symptom severity

  • Clinical Global Impression-Severity Scale [ Time Frame: From 3-6 months ] [ Designated as safety issue: No ]
    Investigator-rated global impression of ADHD symptom severity


Enrollment: 82
Study Start Date: August 2004
Study Completion Date: April 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219309

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

No publications provided by Göteborg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mats Johnson, Department of Child Psychiatry, Göteborg University
ClinicalTrials.gov Identifier: NCT01219309     History of Changes
Other Study ID Numbers: Ö761-03
Study First Received: April 29, 2010
Last Updated: October 12, 2010
Health Authority: Ethics Committee Göteborg Sweden:

Keywords provided by Göteborg University:
Attention-deficit/hyperactivity disorder
Omega 3/6 fatty acids
Developmental coordination disorder
Reading/writing difficulties.

Additional relevant MeSH terms:
Agraphia
Attention Deficit Disorder with Hyperactivity
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014