Omega-3 Fatty Acids Supplementation in ADHD

Augmenting the Effects of Methylphenidate: A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids Supplementation in Children With Attention Deficit Hyperactivity Disorder

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01777048

Enrollment

Registered

2013-01-28

Start date

2013-04-30

Completion date

2015-05-31

Last updated

2015-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

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.

Interventions

DIETARY_SUPPLEMENTOmega-3 Fatty Acids Supplementation

DIETARY_SUPPLEMENTOmega-3 Placebo

Placebo capsules manufactured to mimic Omega-3 capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in ADHD Rating Scale-IV total score	Baseline, Week 6, and Week 12

Secondary

Measure	Time frame
Change in Child Behaviour Checklist total score	Baseline and Week 12

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026