Omega-3 Fatty Acids Supplementation in ADHD

ADHD Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01777048
• Other study ID #: 203/12
• Status: Terminated
• Phase: Phase 3
• First received: January 16, 2013
• Last updated: June 23, 2015
• Start date: April 2013
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Dietary Supplement:
• Omega-3 Fatty Acids Supplementation

• Omega-3 Placebo
Placebo capsules manufactured to mimic Omega-3 capsules

Locations

Country	Name	City	State
Switzerland	Universitäre Psychiatrische Kliniken (UPK) Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Universitäre Psychiatrische Kliniken (UPK) Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ADHD Rating Scale-IV total score		Baseline, Week 6, and Week 12	No
Secondary	Change in Child Behaviour Checklist total score		Baseline and Week 12	No