Trial Outcomes & Findings for Omega-3 Supplementation to ADHD Medication in Children (NCT NCT02204410)

NCT ID: NCT02204410

Last Updated: 2017-06-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

Baseline and 12 Weeks

Results posted on

2017-06-29

Participant Flow

IRB-approved flyers were posted in the general community and throughout Massachusetts General Hospital between June 2014 and April 2016.

Participant milestones

Participant milestones
Measure	Omega-3 Fatty Acids and Stimulant Treatment 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.
Overall Study STARTED	21
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Omega-3 Fatty Acids and Stimulant Treatment 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.
Overall Study Lost to Follow-up	5
Overall Study Physician Decision	2
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Omega-3 Supplementation to ADHD Medication in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omega-3 Fatty Acids and Stimulant Treatment n=10 Participants 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.
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	10.6 years STANDARD_DEVIATION 2.6 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 Weeks

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

Outcome measures

Outcome measures
Measure	Omega-3 Fatty Acids and Stimulant Treatment n=10 Participants 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.
Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) Emotional Control Subscale T Score Baseline	65.3 units on a scale Standard Deviation 10.2
Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) Emotional Control Subscale T Score Endpoint	58.4 units on a scale Standard Deviation 13.0

PRIMARY outcome

Timeframe: Baseline and 12 Weeks

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

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

Outcome measures

Outcome measures
Measure	Omega-3 Fatty Acids and Stimulant Treatment n=10 Participants 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.
Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR) CGI Improvement for DESR Baseline	4.6 units on a scale Standard Deviation 0.7
Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR) CGI Improvement for DESR Endpoint	3.0 units on a scale Standard Deviation 0.9

Adverse Events

Omega-3 Fatty Acids and Stimulant Treatment

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Omega-3 Fatty Acids and Stimulant Treatment n=12 participants at risk 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.
Psychiatric disorders Agitated/Tearful	16.7% 2/12 • Number of events 2 • Adverse events were collected from 10/1/2014 to 6/1/2016. Twelve subjects began taking taking open-label treatment with Omega-3 Fatty Acids. All of these subject's are included in adverse event reporting. Ten participants completed a minimum of 6 weeks of the 12 week trial. These 10 participants are included in the data analysis.
General disorders Cold/Infection/Allergy	25.0% 3/12 • Number of events 4 • Adverse events were collected from 10/1/2014 to 6/1/2016. Twelve subjects began taking taking open-label treatment with Omega-3 Fatty Acids. All of these subject's are included in adverse event reporting. Ten participants completed a minimum of 6 weeks of the 12 week trial. These 10 participants are included in the data analysis.
Psychiatric disorders Decreased Energy	8.3% 1/12 • Number of events 1 • Adverse events were collected from 10/1/2014 to 6/1/2016. Twelve subjects began taking taking open-label treatment with Omega-3 Fatty Acids. All of these subject's are included in adverse event reporting. Ten participants completed a minimum of 6 weeks of the 12 week trial. These 10 participants are included in the data analysis.
Nervous system disorders Insomnia	8.3% 1/12 • Number of events 1 • Adverse events were collected from 10/1/2014 to 6/1/2016. Twelve subjects began taking taking open-label treatment with Omega-3 Fatty Acids. All of these subject's are included in adverse event reporting. Ten participants completed a minimum of 6 weeks of the 12 week trial. These 10 participants are included in the data analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal	8.3% 1/12 • Number of events 1 • Adverse events were collected from 10/1/2014 to 6/1/2016. Twelve subjects began taking taking open-label treatment with Omega-3 Fatty Acids. All of these subject's are included in adverse event reporting. Ten participants completed a minimum of 6 weeks of the 12 week trial. These 10 participants are included in the data analysis.
Psychiatric disorders Suicidal Ideation	8.3% 1/12 • Number of events 1 • Adverse events were collected from 10/1/2014 to 6/1/2016. Twelve subjects began taking taking open-label treatment with Omega-3 Fatty Acids. All of these subject's are included in adverse event reporting. Ten participants completed a minimum of 6 weeks of the 12 week trial. These 10 participants are included in the data analysis.
Psychiatric disorders Increased Anxiety	8.3% 1/12 • Number of events 1 • Adverse events were collected from 10/1/2014 to 6/1/2016. Twelve subjects began taking taking open-label treatment with Omega-3 Fatty Acids. All of these subject's are included in adverse event reporting. Ten participants completed a minimum of 6 weeks of the 12 week trial. These 10 participants are included in the data analysis.
Metabolism and nutrition disorders Weight Gain/Increased Appetite	8.3% 1/12 • Number of events 1 • Adverse events were collected from 10/1/2014 to 6/1/2016. Twelve subjects began taking taking open-label treatment with Omega-3 Fatty Acids. All of these subject's are included in adverse event reporting. Ten participants completed a minimum of 6 weeks of the 12 week trial. These 10 participants are included in the data analysis.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • Adverse events were collected from 10/1/2014 to 6/1/2016. Twelve subjects began taking taking open-label treatment with Omega-3 Fatty Acids. All of these subject's are included in adverse event reporting. Ten participants completed a minimum of 6 weeks of the 12 week trial. These 10 participants are included in the data analysis.

Additional Information

Dr. Timothy Wilens

Massachusetts General Hospital

Phone: (617)643-3481

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place