Trial Outcomes & Findings for Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits (NCT NCT01399827)

Last Updated: 2018-10-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Baseline to 12 weeks

Results posted on

2018-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Omega-3 Fatty Acids 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.	Placebo 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 Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omega-3 Fatty Acids n=1 Participants 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.	Placebo n=1 Participants 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 n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	48 years STANDARD_DEVIATION NA • n=93 Participants	21 years STANDARD_DEVIATION NA • n=4 Participants	34.5 years STANDARD_DEVIATION 19.09 • n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Race · White	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Race · Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Outcome measures

Outcome measures
Measure	Omega-3 Fatty Acids n=1 Participants 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.	Placebo n=1 Participants 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.
Mean Change From Baseline to Endpoint on the BRIEF-A Emotional Control Scale	-7 T-Score	-33 T-Score

SECONDARY outcome

Timeframe: baseline to 12 weeks

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.

Outcome measures

Outcome measures
Measure	Omega-3 Fatty Acids n=1 Participants 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.	Placebo n=1 Participants 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.
Efficacy Measured by Mean Change From Baseline to Endpoint on Adult ADHD Investigator Rating Scale (AISRS) Total Score	-14 T-Score	-23 T-Score

SECONDARY outcome

Timeframe: baseline to 12 weeks

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.

Outcome measures

Outcome measures
Measure	Omega-3 Fatty Acids n=1 Participants 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.	Placebo n=1 Participants 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.
Efficacy Measured by Mean Change From Baseline to Endpoint on Clinical Global Impression (CGI) Scale	5 T-Score	1 T-Score

SECONDARY outcome

Timeframe: baseline to 12 weeks

Outcome measures

Outcome measures
Measure	Omega-3 Fatty Acids n=1 Participants 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.	Placebo n=1 Participants 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.
Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales Change in BRIEF-A Inhibit Scale T-Scores from Base	-14 units on a scale	-28 units on a scale
Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales Change in BRIEF-A Shift Scale T-Scores from Baseli	0 units on a scale	-13 units on a scale
Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales Change in BRIEF-A Self Monitor Scale T-Scores from	0 units on a scale	-13 units on a scale
Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales Change in BRIEF-A Initiate Scale T-Scores from Bas	-17 units on a scale	-9 units on a scale
Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales Change in BRIEF-A Working Memory Scale T-Scores fr	-11 units on a scale	-30 units on a scale
Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales Change in BRIEF-A Plan/Organize Scale T-Scores fro	-11 units on a scale	-19 units on a scale
Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales Change in BRIEF-A Task Monitor Scale T-Scores from	-5 units on a scale	-32 units on a scale
Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales Change in BRIEF-A Organization of Materials Scale	-6 units on a scale	-22 units on a scale
Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales Change in BRIEF-A BRI Scale T-Scores from Baseline	-7 units on a scale	-29 units on a scale
Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales Change in BRIEF-A MI Scale T-Scores from Baseline	-12 units on a scale	-46 units on a scale
Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales Change in BRIEF-A GEC Scale T-Scores from Baseline	-11 units on a scale	-29 units on a scale

SECONDARY outcome

Timeframe: baseline to 12 weeks

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.

Outcome measures

Outcome measures
Measure	Omega-3 Fatty Acids n=1 Participants 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.	Placebo n=1 Participants 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.
Efficacy Measured by Mean Change From Baseline to Endpoint on the Global Assessment of Functioning (GAF) Scale	11 units on a scale	8 units on a scale

Adverse Events

Omega-3 Fatty Acids

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Omega-3 Fatty Acids n=1 participants at risk 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.	Placebo n=1 participants at risk 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.
Musculoskeletal and connective tissue disorders Facial discomfort	100.0% 1/1 • Number of events 2 • Baseline to 12 weeks	0.00% 0/1 • Baseline to 12 weeks
General disorders Fish Body Odor	100.0% 1/1 • Number of events 3 • Baseline to 12 weeks	0.00% 0/1 • Baseline to 12 weeks
General disorders Headaches	100.0% 1/1 • Number of events 1 • Baseline to 12 weeks	0.00% 0/1 • Baseline to 12 weeks
Psychiatric disorders Personality Differences	100.0% 1/1 • Number of events 2 • Baseline to 12 weeks	0.00% 0/1 • Baseline to 12 weeks
Eye disorders Eye Discomfort	100.0% 1/1 • Number of events 3 • Baseline to 12 weeks	0.00% 0/1 • Baseline to 12 weeks
Respiratory, thoracic and mediastinal disorders Viral illness	100.0% 1/1 • Number of events 1 • Baseline to 12 weeks	0.00% 0/1 • Baseline to 12 weeks
Eye disorders Puffiness at eye	100.0% 1/1 • Number of events 1 • Baseline to 12 weeks	0.00% 0/1 • Baseline to 12 weeks
Gastrointestinal disorders Nausea	0.00% 0/1 • Baseline to 12 weeks	100.0% 1/1 • Number of events 1 • Baseline to 12 weeks
Gastrointestinal disorders Low appetite	0.00% 0/1 • Baseline to 12 weeks	100.0% 1/1 • Number of events 3 • Baseline to 12 weeks
Musculoskeletal and connective tissue disorders Jittery	0.00% 0/1 • Baseline to 12 weeks	100.0% 1/1 • Number of events 1 • Baseline to 12 weeks

Additional Information

Craig Surman, MD

Massachusetts General Hospital

Phone: 617-726-8392

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place