This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits (NCT01399827), a randomized phase 2 study. The primary outcome is Mean Change From Baseline to Endpoint on the BRIEF-A Emotional Control Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01399827 |
| Phase | Phase 2 |
| Condition | Attention Deficit Hyperactivity Disorder (ADHD), Deficient Emotional Self-Regulation (DESR) |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 2 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Massachusetts General Hospital |
| Results posted | Yes |
2. Clinical Question
Population
Adults aged 18-55 with attention deficit hyperactivity disorder (ADHD) and deficient emotional self-regulation (DESR) traits who were receiving stimulant treatment. The registry record describes the study population this way; the outcome record does not give additional participant characteristics.
Intervention
Omega-3 fatty acid supplementation added to ADHD medication. The omega-3 arm is described as receiving 1060 mg EPA Omega-3 Fatty Acids. The registry record does not give further dosing or treatment-adherence details.
Comparator
Placebo alongside ADHD medication. The registry record identifies the placebo arm but does not describe its ingredients or provide additional details about how medication use was managed across the arms.
Primary question
What mean change from baseline to 12 weeks was recorded on the BRIEF-A Emotional Control Scale in each arm? The scale assesses emotional control, one aspect of cognitive, emotional, and behavioral function. The posted outcome values are -7.0 for omega-3 and -33.0 for placebo, with n=1 in each arm. These observations do not establish a reliable comparative treatment effect.
3. Trial Design
The registry identifies this as a Phase 2, randomized, parallel-group trial with a placebo comparator. Its official title describes a double-blind trial, while the registry masking field says triple masking. The record does not identify which parties were masked, so the precise masking arrangement cannot be clarified from these details alone. The sponsor is Massachusetts General Hospital, and the trial status is completed.
The study was intended to assess omega-3 fatty acids as an addition to stimulant treatment in adults with ADHD and DESR traits. The brief summary describes a 12-week trial in adults aged 18-55. The active arm is named Omega-3 Fatty Acids and is described as 1060 mg EPA Omega-3 Fatty Acids; the comparator is named Placebo. Both arms are presented in the context of ADHD medication.
The registry lists enrollment as 2. For the primary outcome, the posted arm counts are n=1 for omega-3 and n=1 for placebo. These counts describe the outcome record; they do not supply further detail about recruitment, withdrawals, or the analysis population. The start date is recorded as 2012-02, primary completion as 2017-11, and overall status as completed.
The registry record does not report details of sequence generation, allocation concealment, treatment adherence, or the handling of ADHD medication during the study. It also does not report a protocol-level statistical analysis plan or sample-size justification. Those omissions limit how fully the intended design and conduct can be assessed.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Omega-3 Fatty Acids | Placebo |
|---|---|---|
| STARTED | 1 | 1 |
| COMPLETED | 1 | 1 |
| NOT COMPLETED | 0 | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Omega-3 Fatty Acids | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 1 | 1 | 2 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | 1 | 2 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 48 (SD NA) | 21 (SD NA) | 34.5 (SD 19.09) |
| Sex: Female, Male: Female | Participants | 1 | 1 | 2 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Race – White | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Race – Unknown or Not Reported | Participants | 0 | 1 | 1 |
| Region of Enrollment: United States | participants | 1 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Change From Baseline to Endpoint on the BRIEF-A Emotional Control Scale, measured over Baseline to 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | T-Score |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is mean change from baseline to 12 weeks on the BRIEF-A Emotional Control Scale, measured in T-scores. The BRIEF-A is described as a 75-item questionnaire assessing an adult’s cognitive, emotional, and behavioral functions within the past month. Participants rate items on a 3-point scale, and raw scores are used to generate T-scores across the instrument’s scales and summary indices.
The Emotional Control Scale focuses on emotional control rather than every aspect of ADHD or DESR. The record states that T-scores range from 30 to 100 and that scores of at least 65 indicate clinical impairment. It also states that a reduction in score indicates improvement. This makes change on the scale a way to describe whether the measured emotional-control score shifted over the trial period.
The endpoint is a change score, not a final score alone. Interpreting it fully would ordinarily require the number of participants contributing data, the spread of scores, and a comparative estimate with uncertainty. The posted arm values are -7.0 and -33.0, with n=1 in each arm, and no dispersion or confidence interval is reported. The record therefore offers very limited information about variability or the precision of a between-arm comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports mean change from baseline to endpoint on the BRIEF-A Emotional Control Scale as -7.0 in the Omega-3 Fatty Acids arm and -33.0 in the Placebo arm. Each arm has n=1 for this outcome. The endpoint description says that a reduction in T-score indicates improvement, so both posted values represent reductions. They are individual-arm summaries based on one participant apiece, not stable estimates of what would typically occur in either group.
The reported arm values do not support a dependable estimate of the difference between treatment strategies. No dispersion, confidence interval, or inferential test is posted for the primary endpoint. With one observation in each arm, the within-arm variability cannot be estimated from these outcome data. The registry also flags that values are missing or not estimable for a two-arm comparison for this count-other endpoint. Accordingly, there is no suitable comparative estimate to interpret as a treatment effect.
These numbers should not be read as evidence that either arm performs better overall. The pattern is a description of the two posted changes, not a precise comparison that accounts for sampling variability. It also cannot establish whether the observed scores would be reproducible in a larger group. The registry’s reported endpoint values take precedence over any attempt to calculate a contrast from summaries that do not support a valid two-arm analysis.
The record lists four secondary outcomes: mean change in Adult ADHD Investigator Rating Scale (AISRS) Total Score, Clinical Global Impression (CGI) Scale, BRIEF-A subscales, and Global Assessment of Functioning (GAF) Scale. The registry indicates four secondary outcomes posted, but no numerical outcome results or analyses for them are included in the registry record for this analysis. Their presence in the outcome list does not add evidence to the primary comparison.
General statistical context: a confidence interval describes a range of estimates compatible with the observed data under the method’s assumptions. It communicates precision, not certainty about an individual outcome. No confidence interval is reported for this endpoint, and an interval cannot be recovered from the posted arm counts and mean changes alone. The absence of an interval matters because the arm means by themselves do not show how much uncertainty surrounds the estimates.
The registry lists the study as completed, but completion does not resolve the limitations of the posted results. The primary outcome record is too sparse for a meaningful assessment of comparative efficacy. The result is best understood as a small set of descriptive observations, with substantial uncertainty about how they relate to the broader population described in the study summary.
9. Statistical Methods Explained
Several statistical ideas help distinguish what the registry reports from what can be concluded. The main endpoint is a continuous score change: each participant’s baseline score is compared with their endpoint score, and the arm-level result is reported as a mean change. A mean summarizes the center of a set of values. It does not show whether individual values cluster near the mean or vary widely. For this endpoint, the reported arm count is n=1 in each arm, so the mean in each arm is based on one participant and there is no within-arm spread to summarize.
What does randomization contribute?
In general, random assignment is intended to make treatment groups comparable, on average, with respect to factors that could influence an outcome. It supports a causal comparison when the trial is adequately conducted and analyzed. Randomization cannot ensure balance in a very small realized sample, and it does not substitute for outcome data or a suitable analysis. Here, the registry identifies randomized allocation, but the outcome counts are n=1 per arm. That leaves little basis for assessing group comparability or estimating how results vary among participants.
The registry record does not describe the randomization sequence, allocation concealment, or other implementation details. Those methods affect whether assignment could be predicted or influenced. Their absence from the record means readers cannot assess those features from the posted information. This is different from concluding that they were not used; they are simply not reported in the registry record.
What does masking mean for interpretation?
In general, masking is intended to reduce the influence of knowledge about assigned treatment on participant reports, clinical assessments, or other trial procedures. The official title calls this trial double-blind, while the masking field identifies triple masking. The record does not specify which people were masked or how masking was maintained. The differing descriptions therefore cannot be resolved from the registry information alone.
Masking is particularly relevant when an outcome is based on questionnaire ratings, because expectations may influence responses or assessment. That general concern does not establish that bias occurred in this trial. It explains why clear reporting of who was masked and how outcomes were obtained helps readers judge the risk of measurement bias.
Why is a mean change not enough?
A mean change gives a concise description of direction and average magnitude in the recorded arm. A comparative analysis ordinarily needs an estimate of the contrast between arms and a measure of its uncertainty. Standard errors, confidence intervals, or suitable model-based uncertainty measures serve that role. The posted primary outcome values include neither a spread measure nor a confidence interval, and the registry indicates that a two-arm comparison is not estimable for this count-other endpoint. No additional contrast should be inferred from the two arm values.
General statistical context: over-dispersion occurs when outcome variability is greater than a model assumes. If a model underestimates variability, its uncertainty estimates may be too narrow. That issue cannot be evaluated from the primary outcome record because no variability estimate or model result is reported. More generally, statistical methods need to match both the outcome type and the available data; a numeric arm summary alone does not supply enough information to choose or validate a comparative model.
What can sample-size planning say?
Sample-size planning is a forward-looking exercise: it considers how many participants might be needed to detect a specified effect under chosen assumptions. It is distinct from an analysis of the observed data. The registry record does not report the trial’s own sample-size justification or statistical planning details. A planning illustration based on an observed effect, when available, would be hypothetical and would not describe observed power or repair the lack of a reliable comparative estimate in these outcome data.
General statistical context: power is the probability that a specified analysis will detect an effect of a stated size under its assumptions. It is not a measure of how likely the observed result is to be true, and it should not be calculated after a trial as a substitute for an effect estimate and its uncertainty. No observed-power interpretation is warranted from the posted values.
How should the change score be understood?
The outcome is defined as change from baseline to endpoint, with a timeframe of baseline to 12 weeks. The registry’s endpoint description says a lower score indicates improvement. The posted negative mean changes therefore describe lower endpoint scores relative to baseline in the recorded participants. Because only one participant is represented in each arm, these values do not reveal the distribution of individual changes or the likely response across the target population.
For a fuller statistical interpretation, the record would need clearly reported analysis populations, missing-data handling, and comparative estimates with measures of precision. None of those details can be recovered from the arm-level change values. The registry identifies five outcome measures and four posted secondary outcomes, but lists zero analyses in the registry record for this analysis. No statistical test, adjustment method, or model specification is reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome and four secondary outcomes. The secondary outcomes concern AISRS Total Score, CGI Scale, BRIEF-A subscales, and GAF Scale. Considering several outcomes can raise a multiplicity issue: when many hypotheses are tested, the chance of at least one apparently notable result can increase. Statistical plans sometimes address this by designating a primary outcome, adjusting tests, or interpreting secondary findings as exploratory. The registry record does not report a multiplicity strategy or a hierarchy among secondary outcomes beyond identifying the primary endpoint.
The primary outcome details include one mean change for each arm, but no comparative analysis is reported. The record indicates zero analyses and states that values are missing or not estimable for a two-arm comparison for this count-other endpoint. There is no reported test statistic, p-value, confidence interval, or analysis model to interpret. The record also does not give numerical results for the listed secondary outcomes in the registry record used for this analysis.
Missing-data handling and analysis populations are not reported in the registry record. The outcome counts of n=1 in each arm do not, by themselves, explain whether the enrollment count and outcome count align through complete follow-up, exclusions, or another reason. The record does not describe withdrawals, imputation, or any rule for including participants in the analysis. It is therefore not possible to judge whether missing observations affected the reported endpoint or how robust the results are to alternative assumptions.
These are reporting gaps, not proof that a particular procedure was omitted during trial conduct. Without the analysis plan and corresponding results, readers cannot determine how multiplicity, missing data, or population definitions were handled.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Omega-3 Fatty Acids | 0 | 1 | 0.0% |
| Placebo | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Omega-3 Fatty Acids | 0 of 1 |
| Placebo | 0 of 1 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Omega-3 Fatty Acids | 1 of 1 |
| Placebo | 1 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Omega-3 Fatty Acids | Placebo |
|---|---|---|---|
| Facial discomfort | Musculoskeletal and connective tissue disorders | 1 of 1 | 0 of 1 |
| Fish Body Odor | General disorders | 1 of 1 | 0 of 1 |
| Headaches | General disorders | 1 of 1 | 0 of 1 |
| Personality Differences | Psychiatric disorders | 1 of 1 | 0 of 1 |
| Eye Discomfort | Eye disorders | 1 of 1 | 0 of 1 |
| Viral illness | Respiratory, thoracic and mediastinal disorders | 1 of 1 | 0 of 1 |
| Puffiness at eye | Eye disorders | 1 of 1 | 0 of 1 |
| Nausea | Gastrointestinal disorders | 0 of 1 | 1 of 1 |
| Low appetite | Gastrointestinal disorders | 0 of 1 | 1 of 1 |
| Jittery | Musculoskeletal and connective tissue disorders | 0 of 1 | 1 of 1 |
The registry reports serious adverse events for one participant at risk in each arm: zero serious adverse events in the Omega-3 Fatty Acids arm and zero in the Placebo arm. It reports one participant at risk for other adverse events in each arm, with one affected participant in each arm. The deaths count is zero in both arms. No top serious adverse-event terms are listed.
These are counts, not rates, and the denominator in each arm is one participant at risk. Such sparse counts provide very limited information about the frequency or range of adverse events. Zero recorded serious adverse events in an arm does not establish that serious events cannot occur, while the reported other-adverse-event count does not by itself indicate severity, cause, or relation to assigned treatment.
The record does not provide event descriptions for the other adverse events, timing, duration, or an assessment of relatedness. It also does not report further safety analyses in the registry record for this analysis. These figures should therefore be read as a limited description of the events recorded during the trial, not as a broad comparison of safety between treatment strategies.
12. What the Result Does, and Does Not, Mean
The primary outcome record documents mean BRIEF-A Emotional Control T-score changes of -7.0 for omega-3 and -33.0 for placebo from baseline to 12 weeks. The endpoint description says that a reduction in score indicates improvement. The arm counts are n=1 each, so the values describe the recorded observations rather than a dependable estimate of an average response in the population of adults with ADHD and DESR traits.
The record does not provide an estimable two-arm comparison, uncertainty intervals, or a statistical test for this endpoint. It does not show how much change might vary among participants, nor whether any apparent difference between the recorded arm values would persist with more observations. The result therefore cannot establish a treatment effect, its size, or its precision. It also does not support a conclusion that one treatment strategy is better or worse.
The study question is clinically focused on omega-3 supplementation added to ADHD medication and emotional self-regulation. However, this primary endpoint measures a specific BRIEF-A Emotional Control score; it does not directly measure every aspect of ADHD, DESR, daily functioning, or treatment tolerability. The registry lists other outcomes, but numerical findings for them are not reported in the registry record for this analysis. Their titles alone cannot establish effects on those domains.
General statistical context: a trial can generate useful information even when its posted results do not permit a precise comparative estimate, but interpretation must stay within what the data support. Here, the most defensible reading is descriptive and cautious. The registry records a completed Phase 2 study and very limited primary outcome observations. Further information on participant flow, analysis methods, outcome variability, and secondary results would be needed for a fuller assessment.
The result does not establish whether the observed changes were caused by assigned treatment, whether they are reproducible, or how they apply to people outside the study population described in the record. It should not be treated as proof of benefit, lack of benefit, or safety.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the gap between a well-framed clinical question and the amount of outcome information needed to answer it. The registry describes random assignment, a placebo comparator, masking, and a defined 12-week primary endpoint. Yet the posted primary outcome has n=1 in each arm and no reported dispersion or comparative estimate. Design labels alone cannot provide precision when the outcome record is this limited.
The endpoint is a change in a patient-reported scale, which makes clear definitions and complete reporting important. The registry explains the scale’s purpose, score range, impairment threshold, and interpretation of lower scores. Those details make the measure understandable, but they do not reveal how consistent the observed changes were or how much uncertainty surrounds them.
The record also illustrates why distinguishing descriptive arm summaries from comparative evidence matters. Two arm values may appear to invite a direct contrast, but the registry explicitly indicates that a two-arm comparison is not estimable for this outcome format. Respecting that limitation prevents an unsupported calculation from being mistaken for a trial result.
Finally, the registry’s outcome list raises questions about multiplicity, missing data, and analysis populations that cannot be answered from the posted statistical details. These are not merely technical details: they help readers understand what was tested, who contributed data, and how confidently results can be interpreted. The trial matters statistically because it highlights the need for results reporting that pairs outcome values with denominators, uncertainty, analysis methods, and transparent participant flow.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary outcome data are extremely sparse: the registry reports n=1 in each arm. The posted arm values have no dispersion estimates or confidence intervals, and the registry indicates that a two-arm comparison is not estimable. This prevents assessment of sampling variability and makes the arm summaries unsuitable as precise estimates of treatment response.
The registry record does not report a statistical analysis plan, sample-size justification, analysis populations, missing-data procedures, or participant-flow details. It does not describe how allocation was generated or concealed. These details are needed to assess the analysis and potential sources of bias; their absence from the record does not show that the methods were not used.
The official title describes double masking, while the masking field says triple masking, and the record does not identify who was masked. This limits interpretation of how masking may have affected treatment delivery or outcome assessment. The primary endpoint is one BRIEF-A subscale, so it does not capture every study aim described in the summary. Numerical secondary outcome results are not included in the registry record for this analysis, despite the registry listing four secondary outcomes.
The registry’s safety counts are also based on one participant at risk in each arm, with no reported serious adverse events, one other adverse event in each arm, and zero deaths. The record provides no further event detail. Together, these limitations mean the posted information supports only a narrow descriptive account, not a robust comparative assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits — NCT01399827.
- Registry record last updated 2018-10-23; status last verified 2018-09.
- Results first posted 2018-10-23.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed Phase 2 randomized, parallel-group, placebo-controlled trial of omega-3 fatty acids added to ADHD medication among adults with ADHD and DESR traits. The brief summary describes a 12-week study in adults aged 18-55. The active arm is described as 1060 mg EPA Omega-3 Fatty Acids. The official title calls the trial double-blind, while the masking field says triple masking.
The primary outcome is mean change from baseline to 12 weeks on the BRIEF-A Emotional Control Scale. The posted changes are -7.0 for omega-3 and -33.0 for placebo, with n=1 in each arm. No dispersion or precision estimate is reported, and a two-arm comparison is not estimable in the registry record. Four secondary outcomes are listed, but numerical results for them are not included in the registry record for this analysis. Safety counts are limited to one participant at risk per arm. The record does not report the analysis plan, missing-data methods, or analysis populations.