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Omega-3 Polyunsaturated Fatty Acids in Youth With ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder, ADHD

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
n-3 Polyunsaturated fatty acid
Placebo
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, n-3 polyunsaturated fatty acids, children, adolescents

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • DSM-5 diagnosed ADHD
  • Age 6-18 years old at time of enrolment
  • Conner's rating scares (CPRS) with scores >= 2 standard deviations
  • drug native or no medication use for past 6 months
  • Signed informed consent

Exclusion Criteria:

  • Intelligence quotient <70
  • Comorbid other psychiatric disorders, such as autism spectrum disorders, anxiety disorders, conduct disorders, schizophrenia, major depressive disorders and bipolar spectrum disorders
  • Comorbid physical disorders, such as thyroid dysfunction, cerebral palsy
  • Current using omega-3 supplements
  • Allergy to omega-3

Sites / Locations

  • China Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

N-3 polyunsaturated fatty acids

Placebo

Arm Description

n-3 polyunsaturated fatty acids dosage of 1g of Eicosapentaenoic acid(EPA)

olive oil ethyl esters

Outcomes

Primary Outcome Measures

Changes in Continuous Performance Test Raw Scores at 12 weeks
Correct Detection: This indicates the number of times the client responded to the target stimulus. Higher rates of correct detections indicate better attentional capacity. Reaction times: This measures the amount of time between the presentation of the stimulus and the client's response. Omission errors: This indicates the number of times the target was presented, but the client did not respond/click the mouse. High omission rates indicate that the subject is either not paying attention (distractibility) to stimuli or has a sluggish response. Commission errors: This score indicates the number of times the client responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors, indicates inattention in general.

Secondary Outcome Measures

Changes in SNAP-IV Scores for Inattention, Hyperactivity and Total ADHD Symptom Severity
Inattention: items 1-9 Hyperactivity: items 10-18 Total ADHD: items 1-18 the greater the scores on SNAP-IV indicate the greater the severity of ADHD symptoms

Full Information

First Posted
May 20, 2018
Last Updated
June 13, 2018
Sponsor
China Medical University Hospital
Collaborators
National Science Council, Taiwan, King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT03542643
Brief Title
Omega-3 Polyunsaturated Fatty Acids in Youth With ADHD
Official Title
A Double-blind Randomised Controlled Trial of N-3 PUFAs in Children With Attention Deficit Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 7, 2016 (Actual)
Primary Completion Date
December 11, 2017 (Actual)
Study Completion Date
December 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
Collaborators
National Science Council, Taiwan, King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
N-3 polyunsaturated fatty acids(N-3 PUFAs) is important in balancing the immune function and crucial for the developing brain. Deficiency in n-3 PUFAs might be linked to the poor cognitive performances resulting in inattention and hyperactivity in youth with attention deficit hyperactivity disorder (ADHD). N-3 PUFAs appears to be a promising treatment that is safe, beneficial to youth with ADHD. In this proposal, investigators aim the test the hypothesis that n-3 polyunsaturated fatty acids will be more effective than placebo in improving cognitive function in youth with ADHD after 12 weeks of intervention.
Detailed Description
This is a 1-year study and a randomized, double-blind, and placebo controlled Clinical the study. investigators plan to enrol 100 subjects from Child and Adolescent Psychiatry Outpatient Clinic of China Medical University Hospital.Participants will be randomized into omega-3 polyunsaturated fatty acids or placebo group.The intervention period is 12 weeks. Evaluation of the cognitive function ( using Continuous Performance Test 3rd Edition ) of the subjects who are enrolled into the study will take place at baseline and after the 12th week. The symptom severity of ADHD will be measured with Swanson, Nolan, Pelham Questionnaire (SNAP-IV) at baseline, 2,4,8, and 12 weeks. The plasma level of n-3 polyunsaturated fatty acids, blood and salivary inflammatory markers will also be measured at the beginning and at the end of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, ADHD
Keywords
ADHD, n-3 polyunsaturated fatty acids, children, adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N-3 polyunsaturated fatty acids
Arm Type
Active Comparator
Arm Description
n-3 polyunsaturated fatty acids dosage of 1g of Eicosapentaenoic acid(EPA)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
olive oil ethyl esters
Intervention Type
Dietary Supplement
Intervention Name(s)
n-3 Polyunsaturated fatty acid
Intervention Description
1g of Eicosapentaenoic acid (EPA)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Olive oil ethyl esters
Primary Outcome Measure Information:
Title
Changes in Continuous Performance Test Raw Scores at 12 weeks
Description
Correct Detection: This indicates the number of times the client responded to the target stimulus. Higher rates of correct detections indicate better attentional capacity. Reaction times: This measures the amount of time between the presentation of the stimulus and the client's response. Omission errors: This indicates the number of times the target was presented, but the client did not respond/click the mouse. High omission rates indicate that the subject is either not paying attention (distractibility) to stimuli or has a sluggish response. Commission errors: This score indicates the number of times the client responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors, indicates inattention in general.
Time Frame
Week 0 and Week 12
Secondary Outcome Measure Information:
Title
Changes in SNAP-IV Scores for Inattention, Hyperactivity and Total ADHD Symptom Severity
Description
Inattention: items 1-9 Hyperactivity: items 10-18 Total ADHD: items 1-18 the greater the scores on SNAP-IV indicate the greater the severity of ADHD symptoms
Time Frame
Week 0, 2,4,8,12
Other Pre-specified Outcome Measures:
Title
Changes in Blood PUFAs levels at 12 Weeks
Description
measurement of blood PUFAs levels
Time Frame
Week 0 and Week 12
Title
Changes in Blood Inflammatory Markers at 12 Weeks
Description
measurements of blood inflammatory markers
Time Frame
Week 0 and Week 12
Title
Changes in Salivary Cortisol at 12 Weeks
Description
measurements of salivary cortisol
Time Frame
Week 0 and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-5 diagnosed ADHD Age 6-18 years old at time of enrolment Conner's rating scares (CPRS) with scores >= 2 standard deviations drug native or no medication use for past 6 months Signed informed consent Exclusion Criteria: Intelligence quotient <70 Comorbid other psychiatric disorders, such as autism spectrum disorders, anxiety disorders, conduct disorders, schizophrenia, major depressive disorders and bipolar spectrum disorders Comorbid physical disorders, such as thyroid dysfunction, cerebral palsy Current using omega-3 supplements Allergy to omega-3
Facility Information:
Facility Name
China Medical University
City
Taichung
ZIP/Postal Code
404
Country
Taiwan

12. IPD Sharing Statement

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Omega-3 Polyunsaturated Fatty Acids in Youth With ADHD

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