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 Efficacy of Quetiapine for Pediatric Delirium (NCT02056171), a randomized phase 1, phase 2 study. The primary outcome is Time to First Resolution of Delirium.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02056171 |
| Phase | Phase 1, Phase 2 |
| Condition | Delirium |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 6 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Weill Medical College of Cornell University |
| Results posted | Yes |
2. Clinical Question
Population
Children with delirium were eligible for this study. The registry says all participants were included in the analysis, and records an enrollment of 6. It does not report further characteristics of the participants or eligibility details in the record summarized for this trial.
Intervention
The intervention was quetiapine, a drug, started as study treatment for delirium. The registry does not report the dose, schedule, route, or duration of treatment in the record summarized for this trial.
Comparator
The comparator was placebo. The arm description states that participants assigned to placebo did not receive quetiapine. Further details about placebo administration are not reported in the registry record.
Primary question
The primary outcome was time, in days, from study drug initiation to the first resolution of delirium. Resolution was defined as a Cornell Assessment of Pediatric Delirium score less than 9. The measure was assessed within the first 10 days after enrollment; a participant whose delirium did not resolve during that period was assigned a value of 10 days.
The clinical question is whether the recorded time to first resolution differed between the randomized quetiapine and placebo groups in this pediatric delirium study. The registry reports a mean of 8.0 days in the quetiapine group and 7.0 days in the placebo group. Each group contained 3 participants. The posted dispersion measure is the full range: 4.0 to 10.0 days for quetiapine and 2.0 to 10.0 days for placebo.
Those outcome summaries describe this small enrolled sample; they do not establish a treatment effect. The registry record does not report an inferential comparison, confidence interval, or p-value. It also does not provide information needed to assess whether the groups differed in important baseline features. The study's stated purpose included safety and efficacy, but the posted primary outcome is specifically time to first resolution of delirium. This distinction matters: the reported endpoint is a time measure with a fixed 10-day limit, not a general assessment of every aspect of delirium or treatment response.
3. Trial Design
NCT02056171, titled Efficacy of Quetiapine for Pediatric Delirium, is listed as a Phase 1 and Phase 2 study. It used randomized allocation, a parallel-group model, and quadruple masking. The registry identifies Weill Medical College of Cornell University as the sponsor. The study began in 2015-03, had a primary completion date of 2016-12, and is listed as terminated. The reason for termination is not reported in the registry record.
The recorded enrollment was 6. The results are organized into a quetiapine group of 3 participants and a placebo group of 3 participants. The intervention record identifies quetiapine as a drug and placebo as the comparator. The descriptions state that the quetiapine group received quetiapine as treatment for delirium, while the placebo group received placebo and not quetiapine. Dose, treatment schedule, route, duration, and details about concomitant care are not reported in the registry record.
Randomization is intended to allocate participants by chance, reducing the possibility that treatment assignment is determined by participant or clinician characteristics. Masking is intended to limit knowledge of assignment that could affect care, outcome assessment, or reporting. These are general design purposes; the registry does not describe how allocation was generated or concealed, who specifically was masked, or how masking was maintained.
A parallel-group design assigns participants to a study group and compares outcomes across groups. With only 3 participants in each group, the posted estimates are based on a very small set of observations. The registry does not report the planned enrollment target, the basis for the enrollment, or whether recruitment stopped for a particular reason. Nor does it report protocol deviations, participant flow, or details of the study's conduct beyond the listed design characteristics and dates. Termination status should therefore be read as a registry status, not as evidence about why the study ended or what investigators concluded.
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 | Quetiapine | Placebo |
|---|---|---|
| STARTED | 3 | 3 |
| COMPLETED | 3 | 3 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All participants are included in analysis.
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 | Quetiapine | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 3 | 3 | 6 | |
| Age, Categorical: <=18 years | Participants | 3 | 3 | 6 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 4 (3 to 18) | 3 (2 to 3) | 3 (2 to 18) |
| Sex: Female, Male: Female | Participants | 1 | 2 | 3 |
| Sex: Female, Male: Male | Participants | 2 | 1 | 3 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 1 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 2 | 2 | 4 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): White | Participants | 1 | 2 | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 3 | 3 | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Time to First Resolution of Delirium, measured over Within the first 10 days after study enrollment.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | days |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is time to first resolution of delirium, measured in days from study drug initiation. Participants were screened for delirium daily. Resolution was defined as a score less than 9 on the Cornell Assessment of Pediatric Delirium. The outcome timeframe was within the first 10 days after study enrollment. If delirium did not resolve within that period, the endpoint was assigned a value of 10 days.
A time-to-resolution measure captures how long it takes for a defined change to occur, rather than simply whether that change occurred at a single assessment. In general, time-based endpoints can be useful when the timing of an event is clinically relevant. Here, the daily screening schedule supplies the registry's stated approach to observing resolution. The fixed 10-day rule also means the outcome is limited to that observation window: participants without documented resolution in the window receive the maximum stated value, rather than an unbounded time or a separate category in the reported summary.
The registry reports the mean and full range for each group. The mean describes the average recorded time, while the range gives the lowest and highest recorded values. The posted quetiapine mean is 8.0 days, with a full range of 4.0 to 10.0 days; the placebo mean is 7.0 days, with a full range of 2.0 to 10.0 days. These summaries do not show each participant's observation or explain how unresolved cases were distributed. The registry does not report additional details about endpoint adjudication or handling of incomplete assessments.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome is a mean time to first delirium resolution of 8.0 days in the quetiapine group and 7.0 days in the placebo group. The full range is 4.0 to 10.0 days for quetiapine and 2.0 to 10.0 days for placebo. There were 3 participants in each group. These are descriptive summaries of the enrolled participants; the registry record does not report a statistical test or an inferential estimate for the between-group comparison.
The ranges overlap, and both extend to 10.0 days, the endpoint value assigned when delirium did not resolve within the specified 10-day period. The summaries do not reveal which participants reached resolution, which were assigned the 10-day value, or how observations were distributed between the endpoints of each range. Means and ranges can help describe the recorded outcomes, but they cannot by themselves indicate how uncertain a group comparison is. A confidence interval, if reported, would describe the precision of an estimate under the assumptions of its method; no confidence interval is reported in the registry record.
The observed group summaries should not be treated as proof of benefit, lack of benefit, or equivalence. With only 3 participants per group, a single participant's value can have substantial influence on the descriptive mean and range. General statistical interpretation also depends on the design, the completeness of outcome ascertainment, and a clear analysis plan. Details of the allocation procedure, missing outcome handling, and planned inferential analyses are not reported in the registry record.
The record lists 3 outcome measures and identifies Total ICU Days With Delirium as a secondary outcome, but it does not post results for that secondary outcome. The registry also lists 0 analyses. Thus, there is no posted analysis of the treatment contrast, no reported p-value, and no stated adjustment for multiple outcomes. The record gives the primary endpoint summaries without an inferential framework that would support a claim about a population-level difference.
These results are best read as a small descriptive dataset under a capped endpoint definition. The recorded values convey the average and observed spread in each randomized group, but they do not establish what would be expected in a larger population or under other treatment settings. The registry's terminated status and the small enrollment provide context for the limited amount of information available; the reason for termination is not reported in the registry record. No conclusion about the efficacy or safety of quetiapine should be drawn from these summaries alone.
9. Statistical Methods Explained
The registry describes a randomized, quadruple-masked, parallel-group study. Random allocation and masking are general design strategies for limiting bias. Randomization aims to make treatment assignment independent of participants' characteristics on average, while masking aims to reduce the influence of knowing an assignment. These design features do not guarantee balanced groups, especially in a very small study, and the record does not describe the particular procedures used to implement them.
What does the mean describe?
The primary endpoint is summarized by a mean in days. In general, a mean is the arithmetic average of the recorded values and offers a compact description of the group's central outcome. It does not show how values are distributed, whether observations cluster near the mean, or whether one observation has a strong influence. The quetiapine mean is 8.0 days and the placebo mean is 7.0 days. Because there are 3 participants in each group, the mean represents a small collection of observations rather than a stable estimate established by a large sample.
What does the full range add?
The full range reports the smallest and largest observed values. In this study, the reported range is 4.0 to 10.0 days for quetiapine and 2.0 to 10.0 days for placebo. A range shows the extent of observed variation, but not the frequency of values between its endpoints. It also does not quantify uncertainty in the mean or in a treatment contrast. The registry reports full range as the dispersion measure and does not report another measure of spread, such as a standard deviation or interquartile range.
How does the 10-day rule affect interpretation?
The endpoint is bounded by the stated 10-day observation period. Participants whose delirium did not resolve within that period were assigned 10 days. In general, a fixed cap makes an outcome straightforward to summarize within the specified window, but it combines the actual timing of resolution with a rule-based value for cases without resolution in the window. Consequently, a mean of the capped values is not a complete description of the underlying time to resolution beyond that period. The registry does not report how many participants reached resolution during the window or how many received the 10-day assignment.
The registry says participants were screened daily and defines the event using a Cornell Assessment of Pediatric Delirium score less than 9. The record does not report details about missing daily assessments, timing of assessments relative to treatment, or procedures for resolving uncertain endpoint classifications. Those details would help readers understand how the event time was assigned. They are not reported in the registry record.
Why are no inferential results available?
The registry reports 0 analyses. It provides group-level values for the primary endpoint but no p-value, confidence interval, model estimate, or formal comparison. In general, a confidence interval communicates the precision of an estimate across values compatible with the data and method. A hypothesis test addresses how compatible the data are with a specified null model. Neither can be reconstructed responsibly from the posted mean and range alone, particularly without participant-level data and the planned analysis method. No statistical test or confidence interval should be inferred from the descriptive summaries.
Likewise, the registry does not report whether an adjusted model was planned, whether any interim analyses were conducted, or whether any covariates were specified. These aspects of the statistical plan are not reported in the registry record. The absence of a posted analysis is not evidence that a particular method was used or that a particular result was obtained.
How should planning illustrations be understood?
Any sample-size planning illustrations associated with these results are based on a stated set of assumptions: a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect to detect expressed as a fraction of the observed effect. The registry notes that these are planning illustrations computed from the observed effect, not the trial's own design. They are hypothetical planning quantities, not observed power and not evidence that the trial was designed to detect those effects. The registry does not report its own sample-size justification.
In general, a planning calculation estimates what sample size would be needed under chosen assumptions. Its output depends on the target effect, variability assumptions, statistical method, and error-rate choices. When the observed effect comes from a very small study, using it as the basis for planning can produce an unstable illustration. The planning assumptions do not validate the observed estimate, replace a prespecified design calculation, or show that the study had adequate precision. The registry does not report additional design assumptions or a protocol-based sample-size calculation.
For time-to-event outcomes, a planning approach may focus on the number of events, whereas other endpoints may use participants per arm. The registry states that its time-to-event planning displays give total events and other displays give participants per arm. These are planning conventions, not a statement that a particular number of events or participants was observed beyond the enrollment and arm counts reported. No claim about observed power follows from a planning illustration.
10. Multiplicity, Missing Data and Analysis Populations
The registry reports 3 outcome measures and names Total ICU Days With Delirium as a secondary outcome. The primary outcome is time to first resolution of delirium. The remaining outcome identities and their detailed measurement descriptions are not reported in the registry record summarized for this study. No results are posted for the named secondary outcome. The registry lists 0 analyses.
When a study evaluates multiple outcomes or conducts multiple statistical tests, the chance of at least one apparently unusual result can increase. General approaches to multiplicity include specifying a primary outcome in advance, controlling an overall error rate, or treating secondary results as exploratory. The registry record does not report a multiplicity strategy, a hierarchy of tests, or any analysis of secondary endpoints. Therefore, there is no basis for describing the posted primary result as adjusted for multiple testing or for interpreting unreported secondary outcomes.
The primary outcome description states that all participants are included in analysis. This gives the registry's stated analysis population, but the record does not provide participant-level disposition, exclusions, protocol deviations, or a detailed account of how missing measurements were handled. It does not report whether any endpoint observations were missing. The 10-day assignment for participants whose delirium did not resolve within the observation period is part of the endpoint definition; it should not be confused with a reported missing-data procedure.
In general, missing-data methods rely on assumptions about why measurements are unavailable and how that relates to observed or unobserved outcomes. Those assumptions and any imputation or sensitivity analyses are not reported in the registry record. With no posted analysis details, readers cannot assess whether analysis choices could have affected the group summaries or how robust the results are to alternative handling of incomplete observations.
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 |
|---|---|---|---|
| Quetiapine | 0 | 3 | 0.0% |
| Placebo | 1 | 3 | 33.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Quetiapine | 0 of 3 |
| Placebo | 0 of 3 |
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 |
|---|---|
| Quetiapine | 0 of 3 |
| Placebo | 0 of 3 |
Most frequent serious adverse event terms
| Event term | Organ system | Quetiapine | Placebo |
|---|---|---|---|
| movement disorder | Musculoskeletal and connective tissue disorders | 0 of 3 | 1 of 3 |
Serious events with the highest arm-level rate: movement disorder (33.3%).
The registry reports serious adverse events for 0 of 3 participants in the quetiapine group and 1 of 3 participants in the placebo group. It reports 0 other adverse events in each group and 0 deaths in each group. These are counts from a study with 3 participants per arm, so they describe the recorded events in this enrolled sample and do not provide a precise estimate of event frequency in a broader population.
The registry lists movement disorder as the top serious adverse event term, with 33.3%. The posted summary does not identify the arm associated with that term or provide further event-level detail, so the term should not be assigned to a particular group on the basis of this record. The total serious-event counts and the listed term are different kinds of information: the counts describe how many participants were recorded as affected, while the term names an event category.
In general, serious adverse event counts do not by themselves establish that a study treatment caused an event. Interpretation also depends on timing, clinical context, definitions, exposure, and comparative uncertainty. Further information on those matters is not reported in the registry record. The small group sizes also mean that the observed counts cannot reliably characterize uncommon harms. These figures should therefore be read as limited safety reporting, not as a definitive comparison between treatments.
12. What the Result Does, and Does Not, Mean
The registry shows that this study enrolled 6 participants and reports a mean time to first resolution of 8.0 days for quetiapine and 7.0 days for placebo. Each group had 3 participants. The full ranges were 4.0 to 10.0 days and 2.0 to 10.0 days, respectively. The endpoint used a defined resolution threshold and assigned 10 days to participants whose delirium did not resolve within the stated window. These details describe what was recorded under the study's endpoint definition.
The results do not establish that quetiapine improves, worsens, or has the same effect on time to delirium resolution compared with placebo. The registry reports no inferential comparison, confidence interval, or p-value. The descriptive summaries do not show participant-level data, and the small number of participants makes them particularly sensitive to individual observations. There is also no posted result for the named secondary outcome, Total ICU Days With Delirium.
The findings do not establish a general safety profile. The record reports serious adverse events in 0 of 3 quetiapine participants and 1 of 3 placebo participants, no other adverse events in either group, and no deaths. Such counts are too limited to characterize risks beyond the study participants, and the registry does not provide enough detail to attribute an event to treatment.
In general, a randomized design can support a comparative interpretation when the conduct, outcomes, and analysis are sufficiently documented and the data are informative. Here, randomization and quadruple masking are recorded design features, but key details of implementation and statistical analysis are not reported in the registry record. The terminated status does not explain why the study ended. Accordingly, the posted results are a small descriptive record, not a conclusive estimate of the treatment effect or a basis for clinical advice.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the difference between having randomized groups and having enough information to estimate a treatment contrast precisely. Random allocation and quadruple masking are important design features, but the recorded enrollment was 6, with 3 participants in each arm. The posted outcome values can be described, yet the study record does not include an inferential comparison or measures of uncertainty.
The endpoint also shows how an operational definition shapes an analysis. Resolution depended on a Cornell Assessment of Pediatric Delirium score less than 9, with daily screening and a 10-day limit. Assigning 10 days when resolution did not occur within the window creates a capped outcome. That rule makes the summary interpretable within a defined period, but it also means the reported mean does not describe timing beyond that period. Knowing how many participants reached the threshold and how many received the capped value would help readers understand the summaries; those counts are not reported.
The record is also a useful example of why secondary outcomes, analysis methods, and study status need context. One secondary outcome is named, but its results are not posted, and the registry lists 0 analyses. The reason for termination and the study's own sample-size justification are not reported. A planning illustration derived from the observed effect is not a substitute for the trial's design rationale or an inferential result.
These features do not make the descriptive data meaningless. They do define what can responsibly be said: the registry documents group means, ranges, and limited adverse-event counts in a very small study. It does not provide the precision or analysis details needed for a robust comparative conclusion. Recognizing that boundary is central to sound statistical reading.
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 most immediate limitation is the small enrollment: 6 participants, with 3 in each group. Group summaries based on so few observations are highly dependent on the specific participants enrolled. The means and ranges do not reveal the participant-level pattern, and the registry reports no confidence interval or formal comparison to convey uncertainty.
The endpoint is limited to a 10-day window, with 10 days assigned when delirium did not resolve within that period. The record does not report how many participants resolved during the window or how many received that assigned value. This limits interpretation of the means as descriptions of event timing. Details about incomplete daily screening, missing endpoint measurements, and the handling of such cases are not reported in the registry record.
The registry does not report the dose, schedule, duration, allocation-generation method, allocation concealment, or masking procedures. It also does not provide participant characteristics, baseline balance, participant flow, protocol deviations, or details of concomitant care. The reason the study was terminated is not reported. These omissions limit assessment of study conduct and the context in which the results arose.
Statistical reporting is limited: the record lists 0 analyses, does not report an inferential comparison, and does not post results for the named secondary outcome. A multiplicity strategy, missing-data approach, interim analyses, and protocol-based sample-size justification are not reported in the registry record. The serious-event summary is also sparse and does not assign the listed movement disorder term to an arm. Together, these limitations mean the results should be treated as descriptive and should not be generalized as a definitive treatment or safety estimate.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy of Quetiapine for Pediatric Delirium — NCT02056171.
- Registry record last updated 2017-12-13; status last verified 2017-12.
- Results first posted 2017-12-13.
- 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
NCT02056171 is a randomized, quadruple-masked, parallel-group Phase 1 and Phase 2 study of quetiapine versus placebo for pediatric delirium. The sponsor is Weill Medical College of Cornell University. The study began in 2015-03, had primary completion in 2016-12, and is listed as terminated; the reason is not reported in the registry record.
Enrollment was 6, with 3 participants in each group. The primary endpoint was time to first resolution of delirium, in days, within the first 10 days after enrollment. The mean was 8.0 days for quetiapine and 7.0 days for placebo; the full ranges were 4.0 to 10.0 days and 2.0 to 10.0 days. The registry reports 0 analyses and no inferential comparison. Serious adverse events affected 0 of 3 participants in the quetiapine group and 1 of 3 in the placebo group; no deaths were reported. These results are descriptive and limited by the small enrollment and sparse analysis reporting.