NCT01777048

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

2.1 years

First QC Date

January 16, 2013

Last Update Submit

June 23, 2015

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

  • Change in ADHD Rating Scale-IV total score

    Baseline, Week 6, and Week 12

Secondary Outcomes (1)

  • Change in Child Behaviour Checklist total score

    Baseline and Week 12

Study Arms (2)

Omega-3 Fatty Acids

EXPERIMENTAL

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

Omega-3 Placebo

PLACEBO COMPARATOR

1g of Omega-3 Placebo per day for 12 weeks: 2 capsules after breakfast and 2 capsules after dinner

Dietary Supplement: Omega-3 Placebo

Interventions

Omega-3 Fatty Acids SupplementationDIETARY_SUPPLEMENT
Omega-3 Fatty Acids
Omega-3 PlaceboDIETARY_SUPPLEMENT

Placebo capsules manufactured to mimic Omega-3 capsules

Omega-3 Placebo

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitäre Psychiatrische Kliniken (UPK) Basel

Basel, 4058, Switzerland

Location

Related Publications (1)

  • Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.

    PMID: 37058600DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Yoon Phaik Ooi, PhD

    University of Basel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 28, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations

CH(1)