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Omega-3 Fatty Acids Supplementation in ADHD

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ClinicalTrials.gov Identifier: NCT01777048
Recruitment Status : Terminated (Low recruitment numbers)
First Posted : January 28, 2013
Last Update Posted : June 24, 2015
Sponsor:
Collaborator:
Universitäre Psychiatrische Kliniken (UPK) Basel
Information provided by (Responsible Party):
Yoon Phaik Ooi, University Hospital, Basel, Switzerland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
ADHD Dietary Supplement: Omega-3 Fatty Acids Supplementation Dietary Supplement: Omega-3 Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Augmenting the Effects of Methylphenidate: A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids Supplementation in Children With Attention Deficit Hyperactivity Disorder
Study Start Date : April 2013
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Change in ADHD Rating Scale-IV total score [ Time Frame: Baseline, Week 6, and Week 12 ]

Secondary Outcome Measures :
  1. Change in Child Behaviour Checklist total score [ Time Frame: Baseline and Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777048


Locations
Switzerland
Universitäre Psychiatrische Kliniken (UPK) Basel
Basel, Switzerland, 4058
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Universitäre Psychiatrische Kliniken (UPK) Basel
Investigators
Study Director: Yoon Phaik Ooi, PhD University of Basel

Responsible Party: Yoon Phaik Ooi, Researcher, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01777048     History of Changes
Other Study ID Numbers: 203/12
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders