- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01777048
Omega-3 Fatty Acids Supplementation in ADHD
June 23, 2015 updated by: Yoon Phaik Ooi, University Hospital, Basel, Switzerland
Augmenting the Effects of Methylphenidate: A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids Supplementation in Children With Attention Deficit Hyperactivity Disorder
The overarching aim of the proposed study is to assess whether omega-3 fatty acids supplementation can augment the effects of methylphenidate in children with ADHD.
The investigators hypothesized that omega-3 fatty acids supplementation will be associated with improved ADHD symptoms.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Basel, Switzerland, 4058
- Universitäre Psychiatrische Kliniken (UPK) Basel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Participants between ages 6 and 12 years who:
- have been clinically diagnosed with ADHD by a physician
- meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
- are willing to participate in a randomized, double-blind, placebo-controlled trial, complete with written, informed parental consent,
- are on stable dosage of methylphenidate treatment before the start of the study
- are able to speak English or German
Exclusion Criteria:
- Participants who are younger than 6 years old or older than 12 years old
- Those who have not been clinically diagnosed with ADHD by a physician
- Those who did not meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
- Those without written parental consent
- Those with brain pathology such as serious head injury, epilepsy, and intellectual disability (IQ < 70)
- Those with titrated dosage of methylphenidate before the start of the study
- Those on neurofeedback training, and/or psychosocial intervention addressing attention problems
- Those with known hypersensitivity to the IMP under investigation
- Those who are unable to read and understand the parent/participant information
- Those receiving medications other than methylphenidate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omega-3 Fatty Acids
1g of Omega-3 per day [400mg DHA & 600mg EPA] for 12 weeks: 2 capsules after breakfast and 2 capsules after dinner
|
|
Placebo Comparator: Omega-3 Placebo
1g of Omega-3 Placebo per day for 12 weeks: 2 capsules after breakfast and 2 capsules after dinner
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Placebo capsules manufactured to mimic Omega-3 capsules
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in ADHD Rating Scale-IV total score
Time Frame: Baseline, Week 6, and Week 12
|
Baseline, Week 6, and Week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Child Behaviour Checklist total score
Time Frame: Baseline and Week 12
|
Baseline and Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Yoon Phaik Ooi, PhD, University of Basel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
January 16, 2013
First Submitted That Met QC Criteria
January 23, 2013
First Posted (Estimate)
January 28, 2013
Study Record Updates
Last Update Posted (Estimate)
June 24, 2015
Last Update Submitted That Met QC Criteria
June 23, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 203/12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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