Omega-3/Omega-6 Fatty Acids for Attention-Deficit/Hyperactivity Disorder (ADHD): A Trial in Children and Adolescents
NCT ID: NCT01219309
Last Updated: 2010-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
82 participants
INTERVENTIONAL
2004-08-31
2007-04-30
Brief Summary
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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
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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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Omega 3/6 treatment
Omega 3/6 fatty acids
3 capsules bid orally
Placebo
Placebo (olive oil)
3 capsules bid orally
Interventions
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Omega 3/6 fatty acids
3 capsules bid orally
Placebo (olive oil)
3 capsules bid orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Met DSM-IV criteria for a diagnosis of ADHD of any subtype
Exclusion Criteria
* 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
8 Years
18 Years
ALL
No
Sponsors
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Vifor Pharma
INDUSTRY
Göteborg University
OTHER
Responsible Party
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Department of Child Psychiatry, Göteborg University
Principal Investigators
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Mats Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
Göteborg University
References
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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.
Other Identifiers
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Ö761-03
Identifier Type: -
Identifier Source: org_study_id