Omega-3 Fatty Acids Supplementation in ADHD

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Hospital, Basel, Switzerland
Sponsor:
Collaborator:
Universitäre Psychiatrische Kliniken (UPK) Basel
Information provided by (Responsible Party):
Yoon Phaik Ooi, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01777048
First received: January 16, 2013
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
ADHD
Dietary Supplement: Omega-3 Fatty Acids Supplementation
Dietary Supplement: Omega-3 Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Change in ADHD Rating Scale-IV total score [ Time Frame: Baseline, Week 6, and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Child Behaviour Checklist total score [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777048

Contacts
Contact: Sibylle Meier sibylle.meier@stud.unibas.ch

Locations
Switzerland
Universitäre Psychiatrische Kliniken (UPK) Basel Recruiting
Basel, Switzerland, 4058
Principal Investigator: Oliver Pick, Dr. med.         
Sub-Investigator: Klaus Schmeck, Dr. med Dip.-Psych.         
Sub-Investigator: Jens Gaab, PhD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Universitäre Psychiatrische Kliniken (UPK) Basel
Investigators
Study Director: Yoon Phaik Ooi, PhD University of Basel
  More Information

No publications provided

Responsible Party: Yoon Phaik Ooi, Researcher, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01777048     History of Changes
Other Study ID Numbers: 203/12
Study First Received: January 16, 2013
Last Updated: April 15, 2013
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014