ADHDPhase 3NCT01219309
Omega-3/Omega-6 Fatty Acids for Attention-Deficit/Hyperactivity Disorder (ADHD): A Trial in Children and Adolescents
A Phase 3 study testing Omega 3/6 fatty acids in people with ADHD and Reading/Writing Disorder, run by Göteborg University.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- ADHD, Reading/Writing Disorder
- What is being tested?
- Omega 3/6 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Apr 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 8-18 years
- Met DSM-IV criteria for a diagnosis of ADHD of any subtype
Who cannot join
- Autism
- Psychosis
- Bipolar disorder
- Mental retardation
- Uncontrolled seizure disorder
- Hyper- or hypothyroidism
Show all 9Show fewer
- 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
About this study
Official title: Omega-3/Omega-6 Fatty Acids for ADHD. A Randomized Placebo-controlled Trial in Children and Adolescents
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.
Read the 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
- Conditions
- ADHD, Reading/Writing Disorder
- Being tested
- Omega 3/6 fatty acids, Placebo (olive oil)
- Keywords
- Attention-deficit/hyperactivity disorder, Omega 3/6 fatty acids, Developmental coordination disorder, Reading/writing difficulties.
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3/6 fatty acidsDietary supplement
Also called eyeq
3 capsules bid orally
Placebo (olive oil)Dietary supplement
3 capsules bid orally
| Study group | Role | What they receive |
|---|---|---|
| Omega 3/6 treatment | Active comparator | Not described Receives: Dietary Supplement: Omega 3/6 fatty acids |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo (olive oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From 0-3 months
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
Measured: From 3-6 months
Secondary outcomes (2)
Clinical Global Impression-Severity Scale
Investigator-rated global impression of ADHD symptom severity
Measured: From 0-3 months
Clinical Global Impression-Severity Scale
Investigator-rated global impression of ADHD symptom severity
Measured: From 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startAug 2004
- Primary completionJun 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Investigators
- Mats Johnson, MD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219309
- Sponsor's protocol ID
- Ö761-03
- Status last verified
- Apr 2010
- First submitted
- 29 Apr 2010
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22753087
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3/Omega-6 Fatty Acids for ADHD. A Randomized Placebo-controlled Trial in Children and Adolescents
- ClinicalTrials.gov ID
- NCT01219309
- Acronym / sponsor ID
- Ö761-03
- Conditions
- ADHD, Reading/Writing Disorder
- Keywords
- Attention-deficit/hyperactivity disorder, Omega 3/6 fatty acids, Developmental coordination disorder, Reading/writing difficulties.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- Aug 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega 3/6 treatment | Active comparator | Dietary Supplement: Omega 3/6 fatty acids |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (olive oil) |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients aged 8-18 years
- Met DSM-IV criteria for a diagnosis of ADHD of any subtype
Key exclusion criteria (9 listed)
- Autism
- Psychosis
- Bipolar disorder
- Mental retardation
- Uncontrolled seizure disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3/6 fatty acidsAlso: eyeq3 capsules bid orally | Dietary supplement | Omega 3/6 treatment |
| Placebo (olive oil)3 capsules bid orally | Dietary supplement | Placebo |
Primary outcome
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
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
2 secondary outcomes
Clinical Global Impression-Severity Scale
Time frame: From 0-3 months
Clinical Global Impression-Severity Scale
Time frame: From 3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
- Derived from this study: PubMed 22753087Johnson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mats Johnson, MD principal investigator
Göteborg University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega 3/6 fatty acids in people with ADHD and Reading/Writing Disorder, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD-Rating Scale, Investigator-rated (time frame: From 0-3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01219309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2010.