Attention Deficit Hyperactivity DisorderPhase 4NCT02204410

Omega-3 Supplementation to ADHD Medication in Children

A Phase 4 study testing Omega-3 Fatty Acid and ADHD Medication in people with Attention Deficit Hyperactivity Disorder and Deficient Emotional Self-Regulation, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder, Deficient Emotional Self-Regulation
What is being tested?: Omega-3 Fatty Acid and ADHD Medication
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Jul 2014to Aug 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female children ages 6-17 years
Living at home
A diagnosis of ADHD (inattentive, hyperactive/impulsive, or combined type) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) based on clinical assessment
Having a score outside the normal (a T-score of 60 or greater) on the Emotional Control subscale of the Behavior Rating Inventory of Executive Function (parent-report version) or a score outside the normal range (cumulative of 180 or greater) on the Anxious/Depressed, Attention Problems, and Aggressive Behavior subscales of the Child Behavior Checklist for ages (6-18)
Currently on FDA approved traditional stimulant medication (such as Concerta of Adderall XR) or non-stimulant medication (such as Strattera or Tenex) for their ADHD for at least one month
Beings able to come to weekly/monthly study visits for 12 weeks
Having a parent or guardian with a level of understanding of the study

Who cannot join

Having unstable medical illness as determined by the clinician investigator
Having a current diagnosis of schizophrenia or bipolar disorder
Having delusions or hallucinations
Having a bleeding disorder
Taking any other ongoing non-ADHD psychotropic medications other than stable, effective serotonin reuptake inhibitors such as fluoxetine (Prozac), citalopram (Celexa) or medications used on an as-needed basis
Pregnant or nursing females

Show all 13Show fewer

IQ < 70 by previous testing or as judged by the clinician investigator
Illegal substance use
Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
Presence of suicidal risk, or homicidality
Unwilling/unable to comply with study procedures
Allergies to fish or shellfish or omega 3 fish oils; multiple adverse drug reactions
Poor command of the English language

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: A Pilot Study of Omega-3 Fatty Acid Supplementation to ADHD Medication in Children With ADHD and Deficits in Emotional Self-Regulation

This study is a 12-week open-label trial to assess the effectiveness of Omega-3 fatty acids for deficient emotional self-regulation (DESR) as a supplement to Attention Deficit/Hyperactivity Disorder (ADHD) treatment in children and adolescents with Attention Deficit/Hyperactivity Disorder. Subjects will be between the ages of 6-17 and will currently be on medication for their Attention Deficit/Hyperactivity Disorder but still experience DESR traits.

Conditions: Attention Deficit Hyperactivity Disorder, Deficient Emotional Self-Regulation
Being tested: Omega-3 Fatty Acid, ADHD Medication
Keywords: ADHD, Attention Deficit Hyperactivity Disorder, DESR, Deficient Emotional Self-Regulation, Emotional Dysregulation, Omega-3 Fatty Acids, Fish Oil
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omega-3 Fatty AcidDietary supplement
Also called Fish Oil, Nordic Naturals Pro-Omega Junior Omega-3 Fatty Acid, Nordic Omega-3 Fishies
ADHD MedicationDrug
Also called Stimulant, Concerta, Ritalin, Focalin

Study groups in NCT02204410
Study group	Role	What they receive
Omega-3 Fatty Acids and Stimulant Treatment	Experimental	Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment. Receives: Dietary Supplement: Omega-3 Fatty Acid; Drug: ADHD Medication

What is being measured

The primary outcome is the main question the study is designed to answer.

Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)
The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored "Never," "Sometimes," or "Often." Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation.
Measured: Baseline and 12 Weeks
Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)
The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as:
1. Very much improved
2. Much improved
3. Minimally improved
4. No change
5. Minimally worse
6. Much worse
7. Very much worse
Measured: Baseline and 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Aug 2016

First posted30 Jul 2014 (estimated)
Study startJul 2014
Primary completionMay 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02204410
Sponsor's protocol ID: 2014-P-000015
Status last verified: May 2017
First submitted: 28 Jul 2014
Last updated: 29 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD

All Attention Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Omega-3 Fatty Acid Supplementation to ADHD Medication in Children With ADHD and Deficits in Emotional Self-Regulation
ClinicalTrials.gov ID: NCT02204410
Acronym / sponsor ID: 2014-P-000015
Conditions: Attention Deficit Hyperactivity Disorder, Deficient Emotional Self-Regulation
Keywords: ADHD, Attention Deficit Hyperactivity Disorder, DESR, Deficient Emotional Self-Regulation, Emotional Dysregulation, Omega-3 Fatty Acids, Fish Oil
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: Jul 2014
Primary completion: May 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 30 Jul 2014 (estimated)
Results: Posted 29 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Omega-3 Fatty Acids and Stimulant Treatment	Experimental	Dietary Supplement: Omega-3 Fatty Acid, Drug: ADHD MedicationParticipants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

Male or female children ages 6-17 years
Living at home
A diagnosis of ADHD (inattentive, hyperactive/impulsive, or combined type) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) based on clinical assessment
Having a score outside the normal (a T-score of 60 or greater) on the Emotional Control subscale of the Behavior Rating Inventory of Executive Function (parent-report version) or a score outside the normal range (cumulative of 180 or greater) on the Anxious/Depressed, Attention Problems, and Aggressive Behavior subscales of the Child Behavior Checklist for ages (6-18)
Currently on FDA approved traditional stimulant medication (such as Concerta of Adderall XR) or non-stimulant medication (such as Strattera or Tenex) for their ADHD for at least one month

Key exclusion criteria (13 listed)

Having unstable medical illness as determined by the clinician investigator
Having a current diagnosis of schizophrenia or bipolar disorder
Having delusions or hallucinations
Having a bleeding disorder
Taking any other ongoing non-ADHD psychotropic medications other than stable, effective serotonin reuptake inhibitors such as fluoxetine (Prozac), citalopram (Celexa) or medications used on an as-needed basis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omega-3 Fatty AcidAlso: Fish Oil, Nordic Naturals Pro-Omega Junior Omega-3 Fatty Acid, Nordic Omega-3 Fishies	Dietary supplement	Omega-3 Fatty Acids and Stimulant Treatment
ADHD MedicationAlso: Stimulant, Concerta, Ritalin, Focalin	Drug	Omega-3 Fatty Acids and Stimulant Treatment

Primary outcome

Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)
Time frame: Baseline and 12 Weeks
The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored "Never," "Sometimes," or "Often." Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation.
Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)
Time frame: Baseline and 12 Weeks
The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse

Results and safety

Results posted to the registry on 29 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omega-3 Fatty Acids and Stimulant Treatment	21	10

Primary outcome: Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)

Time frame: Baseline and 12 Weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Omega-3 Fatty Acids and Stimulant Treatment n = 10
Emotional Control Subscale T Score Baseline	65.3 (10.2)
Emotional Control Subscale T Score Endpoint	58.4 (13.0)

Population analysed: Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.

Primary outcome: Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)

Time frame: Baseline and 12 Weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Omega-3 Fatty Acids and Stimulant Treatment n = 10
CGI Improvement for DESR Baseline	4.6 (0.7)
CGI Improvement for DESR Endpoint	3.0 (0.9)

Population analysed: Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.

Adverse events

Time frame: Adverse events were collected from 10/1/2014 to 6/1/2016.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omega-3 Fatty Acids and Stimulant Treatment	0 of 12 (0%)	9 of 12 (75%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Attention Deficit Hyperactivity Disorder

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Timothy E. Wilens, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) (time frame: Baseline and 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02204410.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.