Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits

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: NCT01399827
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Craig B. Surman, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Attention Deficit Hyperactivity Disorder (ADHD)
Deficient Emotional Self-Regulation (DESR)
Interventions Drug: ADHD Medication
Drug: Omega-3 Fatty Acids
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description

1060 mg EPA Omega-3 Fatty Acids

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.

Omega-3 Fatty Acids: Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study.

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.
Period Title: Overall Study
Started 1 1
Completed 1 1
Not Completed 0 0
Arm/Group Title Omega-3 Fatty Acids Placebo Total
Hide Arm/Group Description

1060 mg EPA Omega-3 Fatty Acids

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.

Omega-3 Fatty Acids: Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study.

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication. Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
2
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 2 participants
48 [1]   (NA) 21 [1]   (NA) 34.5  (19.09)
[1]
There is no standard deviation because there was only one participant.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
1
 100.0%
1
 100.0%
2
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 1 participants 1 participants 2 participants
White
1
 100.0%
0
   0.0%
1
  50.0%
Unknown or Not Reported
0
   0.0%
1
 100.0%
1
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1 1 2
1.Primary Outcome
Title Mean Change From Baseline to Endpoint on the BRIEF-A Emotional Control Scale
Hide Description The BRIEF-A is a 75-item questionnaire that assesses and adult’s cognitive, emotional, and behavioral functions within the past month. The subject rates each question on a 3-point scale (1=Never, 2=Sometimes, 3=Often). Raw scores are calculated and used to generate T-scores for 8 scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials), 2 summary index scales (Behavioral Regulation Index and Metacognition Index), and one scale reflecting overall functioning (Global Executive Composite). T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement.
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:

1060 mg EPA Omega-3 Fatty Acids

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.

Omega-3 Fatty Acids: Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study.

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: T-Score
-7 -33
2.Secondary Outcome
Title Efficacy Measured by Mean Change From Baseline to Endpoint on Adult ADHD Investigator Rating Scale (AISRS) Total Score
Hide Description The Adult ADHD Investigator Rating Scale (AISRS) measures ADHD symptoms in adults. This scale is an investigator rated scale. Higher scores on this scale indicate more severe ADHD-like symptoms. Patients symptoms are rated as "never", "rarely", "sometimes", "often", or "very often" by the investigator. Total score ranges from 0 to 54. T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement.
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:

1060 mg EPA Omega-3 Fatty Acids

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.

Omega-3 Fatty Acids: Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study.

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: T-Score
-14 -23
3.Secondary Outcome
Title Efficacy Measured by Mean Change From Baseline to Endpoint on Clinical Global Impression (CGI) Scale
Hide Description The Clinical Global Impression (CGI) is a 3-item observer-rated scale that measures illness severity (CGIS), global improvement or change (CGIC) and therapeutic response (CGIE). Scores range from 0 to 7 on each subscale. Total scores range from 0 to 21. T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement.
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:

1060 mg EPA Omega-3 Fatty Acids

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.

Omega-3 Fatty Acids: Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study.

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: T-Score
5 1
4.Secondary Outcome
Title Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales
Hide Description The BRIEF-A is a 75-item questionnaire that assesses and adult’s cognitive, emotional, and behavioral functions within the past month. The subject rates each question on a 3-point scale (1=Never, 2=Sometimes, 3=Often). Raw scores are calculated and used to generate T-scores for 8 scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials), 2 summary index scales (Behavioral Regulation Index and Metacognition Index), and one scale reflecting overall functioning (Global Executive Composite). T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement.
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:

1060 mg EPA Omega-3 Fatty Acids

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.

Omega-3 Fatty Acids: Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study.

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: units on a scale
Change in BRIEF-A Inhibit Scale T-Scores from Base -14 -28
Change in BRIEF-A Shift Scale T-Scores from Baseli 0 -13
Change in BRIEF-A Self Monitor Scale T-Scores from 0 -13
Change in BRIEF-A Initiate Scale T-Scores from Bas -17 -9
Change in BRIEF-A Working Memory Scale T-Scores fr -11 -30
Change in BRIEF-A Plan/Organize Scale T-Scores fro -11 -19
Change in BRIEF-A Task Monitor Scale T-Scores from -5 -32
Change in BRIEF-A Organization of Materials Scale -6 -22
Change in BRIEF-A BRI Scale T-Scores from Baseline -7 -29
Change in BRIEF-A MI Scale T-Scores from Baseline -12 -46
Change in BRIEF-A GEC Scale T-Scores from Baseline -11 -29
5.Secondary Outcome
Title Efficacy Measured by Mean Change From Baseline to Endpoint on the Global Assessment of Functioning (GAF) Scale
Hide Description The Global Assessment of Functioning (GAF) scale is used to rate how serious a mental illness may be. Lower scores on this scale indicate a lower level of functioning and higher severity of symptoms. Total scores range from 0 to 100.
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:

1060 mg EPA Omega-3 Fatty Acids

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.

Omega-3 Fatty Acids: Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study.

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: units on a scale
11 8
Time Frame Baseline to 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description

1060 mg EPA Omega-3 Fatty Acids

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.

Omega-3 Fatty Acids: Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study.

ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.
All-Cause Mortality
Omega-3 Fatty Acids Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)      0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Omega-3 Fatty Acids Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/1 (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 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/1 (100.00%)    
Eye disorders     
Eye Discomfort   1/1 (100.00%)  3 0/1 (0.00%)  0
Puffiness at eye   1/1 (100.00%)  1 0/1 (0.00%)  0
Gastrointestinal disorders     
Nausea   0/1 (0.00%)  0 1/1 (100.00%)  1
Low appetite   0/1 (0.00%)  0 1/1 (100.00%)  3
General disorders     
Fish Body Odor   1/1 (100.00%)  3 0/1 (0.00%)  0
Headaches   1/1 (100.00%)  1 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Facial discomfort   1/1 (100.00%)  2 0/1 (0.00%)  0
Jittery   0/1 (0.00%)  0 1/1 (100.00%)  1
Psychiatric disorders     
Personality Differences   1/1 (100.00%)  2 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Viral illness   1/1 (100.00%)  1 0/1 (0.00%)  0
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
Layout table for Results Point of Contact information
Name/Title: Craig Surman, MD
Organization: Massachusetts General Hospital
Phone: 617-726-8392
EMail: csurman@partners.org
Layout table for additonal information
Responsible Party: Craig B. Surman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01399827     History of Changes
Other Study ID Numbers: 2010-P-002435
First Submitted: July 20, 2011
First Posted: July 22, 2011
Results First Submitted: May 17, 2018
Results First Posted: October 23, 2018
Last Update Posted: October 23, 2018