Omega-3 Fatty Acids Supplementation in ADHD

Phase 3

Terminated

• Conditions: ADHD
• Interventions: Dietary Supplement: Omega-3 Fatty Acids Supplementation; Dietary Supplement: Omega-3 Placebo

• Registration Number: NCT01777048
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Study Start: 2013-04
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega-3 Fatty Acids	Omega-3 Fatty Acids Supplementation	1g of Omega-3 per day \[400mg DHA \& 600mg EPA\] for 12 weeks: 2 capsules after breakfast and 2 capsules after dinner
Omega-3 Placebo	Omega-3 Placebo	1g of Omega-3 Placebo per day for 12 weeks: 2 capsules after breakfast and 2 capsules after dinner

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Child Behaviour Checklist total score	Baseline and Week 12

Trial Locations

Locations (1)

Universitäre Psychiatrische Kliniken (UPK) Basel; 🇨🇭 Basel, Switzerland