Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Omega-3 Supplementation to ADHD Medication in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02204410
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
Timothy Wilens, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Attention Deficit Hyperactivity Disorder
Deficient Emotional Self-Regulation
Interventions Dietary Supplement: Omega-3 Fatty Acid
Drug: ADHD Medication
Enrollment 21
Recruitment Details IRB-approved flyers were posted in the general community and throughout Massachusetts General Hospital between June 2014 and April 2016.
Pre-assignment Details  
Arm/Group Title Omega-3 Fatty Acids and Stimulant Treatment
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 21
Completed 10
Not Completed 11
Reason Not Completed
Lost to Follow-up             5
Physician Decision             2
Protocol Violation             1
Withdrawal by Subject             3
Arm/Group Title Omega-3 Fatty Acids and Stimulant Treatment
Hide Arm/Group Description 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 Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
10
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
10.6  (2.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)
Hide Description 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.
Time Frame Baseline and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.
Arm/Group Title Omega-3 Fatty Acids and Stimulant Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Emotional Control Subscale T Score Baseline 65.3  (10.2)
Emotional Control Subscale T Score Endpoint 58.4  (13.0)
2.Primary Outcome
Title Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)
Hide Description

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
Time Frame Baseline and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.
Arm/Group Title Omega-3 Fatty Acids and Stimulant Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
CGI Improvement for DESR Baseline 4.6  (0.7)
CGI Improvement for DESR Endpoint 3.0  (0.9)
Time Frame Adverse events were collected from 10/1/2014 to 6/1/2016.
Adverse Event Reporting Description

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.

 
Arm/Group Title Omega-3 Fatty Acids and Stimulant Treatment
Hide Arm/Group Description 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.
All-Cause Mortality
Omega-3 Fatty Acids and Stimulant Treatment
Affected / at Risk (%)
Total   0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Omega-3 Fatty Acids and Stimulant Treatment
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Omega-3 Fatty Acids and Stimulant Treatment
Affected / at Risk (%) # Events
Total   9/12 (75.00%)    
Gastrointestinal disorders   
Vomiting   1/12 (8.33%)  1
General disorders   
Cold/Infection/Allergy   3/12 (25.00%)  4
Metabolism and nutrition disorders   
Weight Gain/Increased Appetite   1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal   1/12 (8.33%)  1
Nervous system disorders   
Insomnia   1/12 (8.33%)  1
Psychiatric disorders   
Agitated/Tearful   2/12 (16.67%)  2
Decreased Energy   1/12 (8.33%)  1
Suicidal Ideation   1/12 (8.33%)  1
Increased Anxiety   1/12 (8.33%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Timothy Wilens
Organization: Massachusetts General Hospital
Phone: (617)643-3481
Responsible Party: Timothy Wilens, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02204410     History of Changes
Other Study ID Numbers: 2014-P-000015
First Submitted: July 28, 2014
First Posted: July 30, 2014
Results First Submitted: April 26, 2017
Results First Posted: June 29, 2017
Last Update Posted: June 29, 2017