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

  • Switzerland
      • 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:

  1. have been clinically diagnosed with ADHD by a physician
  2. meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
  3. are willing to participate in a randomized, double-blind, placebo-controlled trial, complete with written, informed parental consent,
  4. are on stable dosage of methylphenidate treatment before the start of the study
  5. are able to speak English or German

Exclusion Criteria:

  1. Participants who are younger than 6 years old or older than 12 years old
  2. Those who have not been clinically diagnosed with ADHD by a physician
  3. 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)
  4. Those without written parental consent
  5. Those with brain pathology such as serious head injury, epilepsy, and intellectual disability (IQ < 70)
  6. Those with titrated dosage of methylphenidate before the start of the study
  7. Those on neurofeedback training, and/or psychosocial intervention addressing attention problems
  8. Those with known hypersensitivity to the IMP under investigation
  9. Those who are unable to read and understand the parent/participant information
  10. 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
Dietary supplement: Omega-3 Fatty Acids Supplementation
Placebo Comparator: Omega-3 Placebo
1g of Omega-3 Placebo per day for 12 weeks: 2 capsules after breakfast and 2 capsules after dinner
Dietary supplement: Omega-3 Placebo
Placebo capsules manufactured to mimic Omega-3 capsules

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.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Universitäre Psychiatrische Kliniken (UPK) Basel

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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