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

Primary Purpose

ADHD, Reading/Writing Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Omega 3/6 fatty acids
Placebo (olive oil)
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring Attention-deficit/hyperactivity disorder, Omega 3/6 fatty acids, Developmental coordination disorder, Reading/writing difficulties.

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Omega 3/6 treatment

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    Clinical Global Impression-Severity Scale
    Investigator-rated global impression of ADHD symptom severity
    Clinical Global Impression-Severity Scale
    Investigator-rated global impression of ADHD symptom severity

    Full Information

    First Posted
    April 29, 2010
    Last Updated
    October 12, 2010
    Sponsor
    Göteborg University
    Collaborators
    Vifor Pharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01219309
    Brief Title
    Omega-3/Omega-6 Fatty Acids for Attention-Deficit/Hyperactivity Disorder (ADHD): A Trial in Children and Adolescents
    Official Title
    Omega-3/Omega-6 Fatty Acids for ADHD. A Randomized Placebo-controlled Trial in Children and Adolescents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2004 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Göteborg University
    Collaborators
    Vifor Pharma

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ADHD, Reading/Writing Disorder
    Keywords
    Attention-deficit/hyperactivity disorder, Omega 3/6 fatty acids, Developmental coordination disorder, Reading/writing difficulties.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    82 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Omega 3/6 treatment
    Arm Type
    Active Comparator
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Omega 3/6 fatty acids
    Other Intervention Name(s)
    eyeq
    Intervention Description
    3 capsules bid orally
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo (olive oil)
    Intervention Description
    3 capsules bid orally
    Primary Outcome Measure Information:
    Title
    ADHD-Rating Scale, Investigator-rated
    Description
    The scale comprises the 18 DSM-IV items included in the ADHD diagnosis, and each item is assessed on a 0-3 point scale
    Time Frame
    From 0-3 months
    Title
    ADHD-Rating Scale, Investigator-rated
    Description
    The scale comprises the 18 DSM-IV items included in the ADHD diagnosis, and each item is assessed on a 0-3 point scale
    Time Frame
    From 3-6 months
    Secondary Outcome Measure Information:
    Title
    Clinical Global Impression-Severity Scale
    Description
    Investigator-rated global impression of ADHD symptom severity
    Time Frame
    From 0-3 months
    Title
    Clinical Global Impression-Severity Scale
    Description
    Investigator-rated global impression of ADHD symptom severity
    Time Frame
    From 3-6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mats Johnson, MD
    Organizational Affiliation
    Göteborg University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22753087
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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