Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening (NCT03945175), a na phase 3 study. The primary outcome is Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In.

2. Clinical Question

The clinical question is narrower than whether symptoms change during Mydayis treatment. The registered primary outcome is the AISRS total score at Week 2, at the end of the placebo lead-in. The record also lists secondary outcomes at the end of the lead-in and at the end of Mydayis treatment, including AISRS subscales, the Clinical Global Impression-Severity scale, and the 14-Hour Post-Dose Time-Sensitive Adult ADHD Symptom Scale. However, the registry record does not report numerical results for these outcomes.

The described sequence offers observations at different stages, but it is not a randomized comparison between people assigned to active treatment and people assigned to placebo. Since treatment order is fixed and all patients are described as receiving Mydayis after the lead-in, a change between periods would not alone separate a treatment effect from time-related change, expectations, or other influences. The registry record does not report an analysis addressing those possibilities. The study can therefore be understood from its record as an assessment of symptoms across a treatment sequence, but its registered primary endpoint is specifically a score at the end of the lead-in.

3. Trial Design

The registry identifies this as a Phase 3 study with a single-group model, allocation listed as NA, and masking listed as none. It records an enrollment of 52 and a completed status. The study dates are 2020-07-15 for start and 2022-05-11 for primary completion. NYU Langone Health is listed as the sponsor.

The treatment description says patients first underwent a two-week, single-blinded placebo lead-in and then all received four weeks of order-fixed Mydayis treatment. The intervention list includes both MYDAYIS and Placebo, but the registry does not describe a randomized, parallel-group allocation to these interventions. Its design fields instead identify a single group and no allocation. The narrative description of a single-blinded lead-in and the overall masking field are both part of the record; details that would reconcile their scope are not reported in the registry record.

The record describes an outpatient study for adults aged 18-60 with an ADHD diagnosis who met the inclusion criteria and did not meet exclusion criteria. It does not report the full eligibility criteria in the information summarized in the registry. Nor does it report details such as treatment adherence, dose levels, or the timing of every assessment beyond the named outcome timeframes.

The distinction between a lead-in and a control arm is important for interpretation. A lead-in is a period that precedes the active treatment described in the protocol; it is not equivalent to a concurrent control group unless the design and analysis establish such a comparison. Here, the record describes an order-fixed sequence and does not identify a like-for-like randomized control comparison. The posted record also lists 0 analyses, so it does not provide analysis-level estimates that would clarify how outcomes across the periods were compared.

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

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Adult ADHD Investigator Symptom Rating Scale (AISRS) Score at End of Placebo Lead-In, measured over Week 2 (End of Placebo Lead-In).

The primary endpoint is the Adult ADHD Investigator Symptom Rating Scale (AISRS) score at the end of the placebo lead-in, with the timeframe specified as Week 2. The record describes the AISRS as an 18-item questionnaire measuring aspects of ADHD in adults. Each item is ranked on a four-point Likert scale: 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The total is the sum of responses, ranges from 0 to 54, and higher scores indicate greater ADHD symptom severity.

A total score combines item-level responses into a continuous measure that can describe overall symptom burden. Reporting a mean and standard deviation, as specified for this outcome, would convey the group’s average score and the spread of individual scores around that average. The endpoint is clinically interpretable as a symptom-rating measure, but a score at one timepoint does not itself describe change, establish a treatment contrast, or show how precisely a treatment effect has been estimated.

The registry record does not report the primary endpoint’s mean or standard deviation. It therefore does not support a numerical description of the group’s AISRS score at the end of the lead-in. Since this is the primary outcome timepoint and it occurs before the described Mydayis treatment period, it should not be read as a direct estimate of the effect of Mydayis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a continuous score, and the registry specifies that it is to be summarized as a mean with a standard deviation. These statistics answer different descriptive questions. The mean is the arithmetic average of participants’ scores; the standard deviation describes how dispersed individual scores are around that average. A mean alone can obscure substantial variation, while a standard deviation alone does not indicate the group’s average symptom level.

General statistical explanation: a confidence interval expresses uncertainty around an estimate under the assumptions of the method used. Its width depends on the amount and variability of information and on the chosen method. A confidence interval for a treatment contrast would describe uncertainty about that contrast, not merely variation among participants. The registry record does not report a confidence interval for the primary endpoint or a treatment contrast, so its precision cannot be assessed from such an interval.

The AISRS total is formed from 18 item ratings. The registry describes each response as ranging from 0 (none) to 3 (severe), with a total score from 0 to 54 and higher scores indicating greater severity. Summing items is a way to represent overall symptom ratings in one measure. The interpretation remains tied to the instrument and its scoring; it should not be treated as a direct measure of every aspect of ADHD or executive function.

The endpoint’s timeframe is Week 2, at the end of the placebo lead-in. Because the endpoint is recorded before the subsequent Mydayis treatment period described in the study arm, it is a measurement at a particular stage of the sequence rather than an estimate of the change attributable to Mydayis. To estimate a change, an analysis would need at least the relevant outcome values at multiple timepoints and a defined comparison. To attribute a difference to treatment, the design and analysis would also need to address alternative explanations. Such primary outcome values and analyses are not reported in the registry record.

What does a single-group design imply?

General explanation: a single-group design observes participants in one treatment sequence rather than assigning them to concurrent randomized groups. Measurements at different times can describe how outcomes vary during the sequence, but the time contrast can be influenced by factors other than treatment. A concurrent randomized comparator can help distinguish treatment-related differences from changes that would have occurred over time, although the exact interpretation depends on the design and analysis. In this record, allocation is listed as NA, the model is single-group, and treatment order is fixed. The record specifically identifies the study as not being a randomized comparison with like-for-like control arms.

The existence of a placebo lead-in does not, by itself, make the study a placebo-controlled parallel-group trial. The arm description places placebo before Mydayis for all patients. The record does not describe random assignment to separate placebo and active-treatment groups. A within-sequence comparison, if conducted, would require careful interpretation and details of the analysis. The registry lists 0 analyses, and those details are not reported in the registry record.

How should planning calculations be read?

General explanation: sample-size calculations explore how much information a proposed design might need to detect a specified effect under stated assumptions. They depend on choices such as the significance level, allocation, and effect size. They are planning illustrations, not observations, and are not a measure of the probability that a completed study found a true effect. The planning assumptions associated with this record describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects expressed as fractions of an observed effect. Those assumptions describe a hypothetical planning calculation; they do not alter the registry’s single-group design or establish that the trial itself used those choices.

The sample-size assumptions also distinguish calculations for time-to-event outcomes from calculations for other outcomes: time-to-event calculations are expressed as total events, while other calculations are expressed as participants per arm. These are conventions for planning illustrations, not observed trial outcomes. No specific numerical planning result is reported in the registry information, and the registry record does not report a trial-specific sample-size justification. Any planning illustration should therefore be kept separate from observed enrollment and from the unreported primary endpoint results.

Why does over-dispersion matter?

General explanation: over-dispersion means that the observed variability is greater than a statistical model assumes. If a model understates variability, standard errors may be too small and uncertainty intervals may be too narrow. Model choice should reflect the outcome’s distribution and the study design. The primary AISRS outcome is described as a continuous score summarized by a mean and standard deviation, but the registry record does not report a fitted model or details that would allow assessment of distributional assumptions. Over-dispersion is therefore a general methodological consideration, not a reported feature of this study’s analysis.

Because the numerical outcome results and analysis details are not reported, the registry record does not permit an assessment of the calculation method, model assumptions, standard errors, confidence intervals, or sensitivity analyses for the primary endpoint. The descriptive definitions of mean and standard deviation clarify what the planned summary would mean, but they cannot fill in the absent values.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Placebo, Then Mydayis")
n   <- c(18)
m   <- c(37.2)
sp  <- c(11.4)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Placebo, Then Mydayis  18  37.200  11.400  31.531  42.869

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 66 outcome measures and 0 analyses. Multiple outcomes can create a multiplicity issue when several statistical tests are used to support conclusions: the more claims considered, the greater the chance of at least one apparently notable result arising by chance if no adjustment or prespecified hierarchy is used. This is a general statistical concern, not evidence that a particular multiplicity problem occurred in this study. The record does not report a testing hierarchy, a multiplicity adjustment, or the statistical analysis plan; these details are not reported in the registry record.

Outcome names and timeframes do not show which measures were analyzed, which results were intended to be confirmatory, or whether any adjustment was applied. The registry’s count of 0 analyses means no analysis entries are listed in the record; it does not establish what analyses may have been conducted outside the registry. The registry record does not report corresponding numerical estimates or tests for the named secondary outcomes.

Missing-data handling is also not reported in the registry record. There is no reported description of how missing questionnaire items or missing visits were handled, whether participants were included according to a defined analysis population, or whether sensitivity analyses were used. The registry enrollment is 52, whereas the posted safety group lists 18 people at risk for its adverse-event counts. Those figures describe different entries in the record; the reason for the safety denominator and its relationship to enrollment are not reported. They should not be reconciled by assumption.

The registry record does not report interim analyses, stopping rules, or details of analysis populations. Without those details, it is not possible to assess how incomplete observations, multiplicity, or analysis-set definitions may have affected the reported findings. These are unknown reporting details, not grounds to infer that a particular method was or was not used.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The posted safety group is titled “Placebo, Then Mydayis.” It lists 18 people at risk for serious adverse events, 0 with a serious adverse event, 18 at risk for other adverse events, 14 with other adverse events, and 0 deaths. The record lists no top serious adverse-event terms. These are counts for the posted group, not a comparison between randomized treatment groups.

“At risk” is the denominator used for the corresponding event count in this record. The registry lists an enrollment of 52, but the reason the safety figures use 18 as the at-risk count is not reported in the registry record. No explanation for the relationship between these figures should be inferred from the counts alone.

General explanation: a count of 0 serious events means none were recorded among the listed at-risk group in the posted safety data. It does not establish that the risk is absent, and the count does not show how risk would compare with another treatment. Likewise, the count of participants with other adverse events does not, on its own, establish that an event was caused by the study drug. The registry record does not provide a randomized control comparison, event-level timing, or attribution details in the information.

The sequence description places the placebo lead-in before Mydayis, but the adverse-event figures are presented for the combined “Placebo, Then Mydayis” group. The registry does not separate the counts by treatment period in the posted safety figures. The counts should therefore be read as descriptive safety information for the listed group, not as a period-specific or comparative estimate.

13. What the Result Does, and Does Not, Mean

The registry record identifies a completed Phase 3 study of a fixed sequence: a placebo lead-in followed by Mydayis treatment. It specifies a primary AISRS score at the end of the lead-in and lists several additional symptom and severity measures at the end of both periods. It also reports adverse-event counts for a group titled “Placebo, Then Mydayis.” These details describe the study structure and the available posted safety counts.

The primary score’s numerical results are not reported in the registry record. Consequently, the record does not show the group’s mean AISRS score or its standard deviation at the primary timepoint. It does not provide a numerical primary treatment effect, a confidence interval for such an effect, or a p-value. The absence of a posted result cannot be interpreted as evidence that the score was unchanged or that treatment had no effect.

The primary measurement occurs at the end of the placebo lead-in, before the Mydayis period described in the arm information. It therefore does not directly answer whether symptoms changed during active treatment. Although the record names outcomes at the end of Mydayis treatment, their numerical results and an analysis comparing timepoints are not reported in the registry record. In addition, the single-group, order-fixed design does not provide a randomized like-for-like control comparison in the registry description.

The safety figures can be read as counts among the listed at-risk group, but they are not a comparative risk estimate and do not by themselves establish causality. The difference between the registry enrollment and safety denominator is unexplained in the record. It would be inappropriate to treat those entries as if they necessarily refer to the same analysis population.

In short, the record permits a description of the planned sequence, endpoint definitions, and posted safety counts. It does not permit a conclusion about the size or precision of an effect on the primary outcome, a causal treatment comparison, or the reasons for the safety denominator. Those questions require results and analysis details that are not reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically notable for the distinction between an active-treatment sequence and a randomized control comparison. The registry lists a single-group model and allocation as NA, while its treatment description places a placebo lead-in before Mydayis for all patients. Understanding that structure is necessary before interpreting any potential change across time: a before-and-after contrast is not automatically equivalent to a controlled treatment effect.

The primary outcome’s timing is also consequential. It is the AISRS total at the end of the placebo lead-in, not a stated change from the lead-in to the end of Mydayis treatment. The endpoint is a recognized type of symptom-rating summary within the record’s description, with a defined score range and direction. Yet the registry record does not report its numerical mean or standard deviation, so even the descriptive result at that primary timepoint cannot be characterized from the posted information.

The study also illustrates the difference between outcome registration and outcome reporting. The record lists 66 outcome measures, including measures at more than one treatment stage, but lists 0 analyses. Listing outcomes identifies what was intended for assessment; it does not show observed values, effect estimates, uncertainty, or how multiple outcomes were handled. Those gaps limit statistical interpretation independently of the clinical topic.

Finally, planning calculations and observed evidence serve different purposes. A sample-size illustration based on an assumed effect and a hypothetical allocation does not describe the design actually registered, prove that the study was adequately powered, or replace reported results. Keeping those distinctions clear helps prevent planning assumptions, design descriptions, and safety counts from being treated as evidence about an unreported primary outcome.

15. 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 central limitation for interpreting efficacy is that the registry record does not report numerical results for the primary AISRS endpoint. Without a mean and standard deviation, or a treatment contrast and its uncertainty, the primary outcome cannot be characterized quantitatively. The registry lists 0 analyses, and no primary confidence interval, p-value, or model estimate is reported.

The registered primary endpoint is measured at the end of the placebo lead-in, while the described Mydayis treatment follows that period. This timing means the primary endpoint is not itself a measure of change during Mydayis treatment. Although the record names secondary measures at the end of treatment, their numerical results and an analysis comparing the periods are not reported.

The study is registered as single-group with allocation NA, and the treatment sequence is described as order-fixed. Thus, the registry does not describe a randomized comparison with like-for-like control arms. Any comparison across periods would need to account for possible time-related influences, and the relevant analysis is not reported in the registry record.

The record also leaves important analysis and reporting details unresolved. Missing-data procedures, analysis populations, multiplicity handling, interim analyses, and trial-specific sample-size justification are not reported in the registry record. Enrollment is listed as 52, while the safety group’s at-risk counts are 18; the reason for this difference is not reported. The safety figures are not separated by treatment period in the posted information, limiting period-specific interpretation. These limitations concern what the registry record reports and do not establish what analyses or procedures may have occurred outside it.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening — NCT03945175.
• Registry record last updated 2024-03-08; status last verified 2024-03.
• Results first posted 2023-06-29.
• 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.

19. Record Summary

The record describes NCT03945175, a completed Phase 3 study sponsored by NYU Langone Health. It lists enrollment of 52, a single-group model, allocation NA, and masking none. The study start is recorded as 2020-07-15 and primary completion as 2022-05-11.

The described sequence is a two-week, single-blinded placebo lead-in followed by four weeks of order-fixed Mydayis treatment for all patients. The primary outcome is the AISRS total score at the end of the placebo lead-in, specified as Week 2. The registry record does not report its numerical results. It lists 66 outcome measures and 0 analyses.

The posted safety group, “Placebo, Then Mydayis,” lists 18 at risk for serious adverse events, 0 serious adverse events, 18 at risk for other adverse events, 14 with other adverse events, and 0 deaths. The record does not explain why the safety denominator differs from enrollment or provide a randomized comparison.