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 Single Dose Intranasal Oxytocin and Cognitive Effects in Autism (NCT02493426), a randomized phase 2 study. The primary outcome is Reading the Mind in the Eyes Task (RMET).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02493426 |
| Phase | Phase 2 |
| Condition | Autism Spectrum Disorders |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Quadruple |
| Enrollment | 27 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Minnesota |
| Results posted | Yes |
2. Clinical Question
Population
People with autism spectrum disorders were eligible for this phase 2 study. The registry record reports enrollment of 27 participants but does not specify the enrolled participants’ ages or provide further details about the population included in the primary analysis.
Intervention
The intervention was a single dose of intranasal oxytocin, described as an oxytocin nasal spray. The study focused on cognitive rigidity and social perception tasks, with behavioral and physiological responses also mentioned in the study description.
Comparator
The comparator was a placebo described as a saline nasal spray designed to look and feel like the drug intervention. The study used a randomized, quadruple-masked crossover design.
Primary question
The primary outcome was performance on the Reading the Mind in the Eyes Task (RMET), reported as a total raw score. The clinical question was whether performance differed after intranasal oxytocin compared with placebo. The registry record does not report the outcome values or a statistical comparison, so it does not establish the direction or precision of any treatment difference.
3. Trial Design
This phase 2 study, NCT02493426, is listed as completed and sponsored by the University of Minnesota. It enrolled 27 participants with autism spectrum disorders. The registry record describes the study as randomized, quadruple-masked, and crossover. In a crossover design, participants receive more than one study condition, so comparisons can use measurements from the same person under different conditions. That structure can account for some stable differences between participants, but it also makes the timing and conduct of treatment periods relevant to interpretation.
The two interventions were intranasal oxytocin and placebo. The placebo was a saline nasal spray designed to resemble the drug intervention. The brief study description refers to two laboratory sessions in which participants would receive either single-dose intranasal oxytocin or placebo and perform tasks. The registry record does not report the treatment sequence, the interval between sessions, or whether a washout period was used. It also does not provide enough detail to reconstruct how the crossover periods were analyzed.
The listed primary outcome was the Reading the Mind in the Eyes Task, with a timeframe of 2 weeks. The registry record does not clarify how that timeframe maps to the treatment sessions or provide a more detailed assessment schedule. It lists three outcome measures overall, but does not report a primary outcome comparison. The record also lists no analyses. Thus, design features are available, but the statistical approach and the primary efficacy findings cannot be evaluated from the registry information presented.
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 | Placebo Then Intranasal Oxytocin | Intranasal Oxytocin Then Placebo |
|---|---|---|
| STARTED | 14 | 13 |
| COMPLETED | 14 | 12 |
| NOT COMPLETED | 0 | 1 |
Reasons for not completing this period:
| Reason | Placebo Then Intranasal Oxytocin | Intranasal Oxytocin Then Placebo |
|---|---|---|
| Withdrawal by Subject | 0 | 1 |
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 | All Participants |
|---|---|---|
| Participants analysed | 27 | |
| Age, Categorical: <=18 years | Participants | 22 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 24 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 19 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Reading the Mind in the Eyes Task (RMET), measured over 2 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | total raw score |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is performance on the Reading the Mind in the Eyes Task (RMET), a social cognition task. The recorded measure is the total raw score, defined in the registry as the number of correct responses. Its stated possible range is from 0 to 28, and a higher score is described as better performance. This makes the endpoint a continuous measure: it can take a range of numerical values rather than representing only whether an event occurred.
A task-based measure can provide a standardized way to assess performance on a specific aspect of social perception. In this study, the RMET was selected as the primary outcome in a trial examining cognitive effects of intranasal oxytocin. The score captures task performance, not every aspect of social cognition or everyday functioning. Its meaning therefore depends on the task, the assessment conditions, and the population studied.
The registry record identifies the measure, unit, direction, and timeframe of 2 weeks, but does not report the observed scores, a treatment contrast, or a confidence interval. Without those results, it is not possible to determine how scores compared between conditions or how precisely any difference was estimated. The endpoint’s description alone does not establish that either intervention changed task performance.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a relevant design question: whether RMET performance differs following a single dose of intranasal oxytocin compared with placebo in a randomized crossover study. However, it does not report the primary outcome values or a statistical comparison. It therefore supports a description of the question and design, but not a conclusion about the direction, size, or precision of a difference in scores.
The outcome is a continuous raw score, and the registry describes higher scores as better performance. For a treatment comparison, the estimated difference would need to be considered alongside its uncertainty. A confidence interval conveys a range of values compatible with the data under the analysis assumptions. A narrow interval would indicate greater precision than a wide interval; neither the estimate nor its interval is reported in the registry record. A p-value is also not reported. No conclusion about statistical evidence for a difference can be drawn from the available outcome information.
The crossover structure matters. Because the same participants may contribute measurements under both conditions, an appropriate analysis would generally account for the within-participant relationship rather than treating all observations as independent. The registry record does not report the treatment sequence, period-specific results, or analysis method, so it is not possible to assess whether within-person pairing, period effects, or possible carryover were addressed. These are considerations for interpreting crossover results, not claims about what the investigators did.
Enrollment was 27, but that number alone does not indicate how many participants contributed usable primary outcome data or how precise a comparison would be. The primary analysis population, missing outcome data, and handling of incomplete participation are not reported in the registry record. The record lists zero analyses and does not provide a primary outcome comparison. Accordingly, the available record cannot support an efficacy conclusion or an estimate of the treatment effect.
Safety information is reported separately: no serious adverse events and no deaths are recorded in either intervention group, while other adverse events are recorded in both. These counts describe the registry entries, not the primary cognitive outcome. They should not be used to infer whether oxytocin changed RMET scores. Overall, the posted information documents the trial’s design and selected endpoint, but leaves the primary result and its statistical uncertainty unreported.
9. Statistical Methods Explained
The primary measure is a continuous outcome: an RMET total raw score. For continuous outcomes, analysts commonly describe the distribution using a mean and a measure of spread, such as the standard deviation. The mean indicates the average score in a group or condition; the standard deviation describes how dispersed individual scores are around that average. These summaries do not show every feature of the score distribution, and they do not by themselves estimate a treatment effect.
A treatment comparison requires a contrast between conditions. In a crossover design, each participant can have an outcome under more than one condition. A paired analysis uses the within-participant relationship between those measurements. This can be useful because stable characteristics of a participant are shared across conditions. A suitable analysis still needs to account for the study’s structure and assumptions. The registry record does not report the primary outcome means, standard deviations, treatment contrast, or analysis method, so the actual statistical procedure cannot be identified.
A confidence interval is a way to express uncertainty around an estimated contrast. It helps readers judge which effect sizes remain compatible with the data and the analysis assumptions. It is not a guarantee that the true effect lies in the interval, nor does it replace consideration of the study design and measurement. The registry record does not report a confidence interval for the primary outcome. A p-value, which measures how incompatible the observed data are with a specified null model under its assumptions, is not reported either. Neither quantity can be inferred from the enrollment count or from the endpoint description.
Masking is intended to limit the influence of knowledge about treatment assignment on study conduct, assessment, or reporting. The registry lists quadruple masking, but does not specify which roles were masked or describe whether masking was assessed. Randomization is intended to reduce systematic differences in treatment assignment. The registry lists randomized allocation, but does not report the allocation procedure or sequence details.
In crossover studies, interpretation can depend on period effects, treatment order, and whether effects from one condition persist into a later period. A washout interval may be relevant when carryover is possible. These are general design considerations; the registry record does not report the treatment sequence, interval between sessions, washout arrangements, or whether the analysis considered period or carryover effects. No claim can therefore be made about how these issues were handled.
Over-dispersion is a general concern when count outcomes vary more than an assumed statistical model allows. It is not a direct description of the primary endpoint here, which is a bounded score rather than a count of events over exposure time. Analysts may still need to consider whether a model’s distributional assumptions fit the observed score data. The registry record does not report the score distribution or model diagnostics, so no conclusion about distributional fit is available.
The registry record provides sample-size planning assumptions in general terms: a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and planning illustrations based on fractions of an observed effect. Such illustrations are planning tools, not evidence that the study had a particular probability of detecting an effect. They are not observed power. The record does not report a trial-specific sample-size justification, and no planning result can establish the precision of the unreported primary comparison.
Finally, the registry lists three outcome measures but zero analyses, and the primary outcome is not reduced to a single comparison in the posted results. The analysis plan, model specification, approach to missing data, and analysis population are not reported in the registry record. These omissions prevent independent evaluation of the statistical methods actually used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures, while identifying the RMET as the primary outcome. The posted results do not provide a single primary comparison, and the registry record lists zero analyses. It does not report whether multiple outcomes, tasks, time points, or subgroup comparisons were considered in the analysis, or whether any adjustment for multiple testing was planned or applied. Without that information, the extent to which multiplicity was addressed cannot be assessed.
Multiplicity matters because interpreting several statistical tests can raise the chance of a misleading positive finding if results are selected or evaluated without an appropriate plan. This is a general statistical concern, not evidence that the study conducted unreported tests. The registry record does not report an analysis plan or interim analyses, so neither their presence nor their absence can be established from the record.
Missing-data handling is also not reported. The record gives enrollment of 27 but does not state how many participants completed each condition, how many RMET scores were available, or how incomplete observations were treated. It does not identify the primary analysis population or describe whether the analysis followed an intention-to-treat principle. In a crossover study, missing measurements in one period can affect which paired observations are available; the record does not explain how such cases were handled.
These gaps matter because the estimated treatment contrast and its uncertainty can depend on which participants and observations are included and on the assumptions used for missing values. The available information is insufficient to assess those choices. No missing-data method or multiplicity procedure should be attributed to the investigators unless it is reported in the registry record.
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 |
|---|---|---|---|
| Placebo | 0 | 27 | 0.0% |
| Intranasal Oxytocin | 0 | 27 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 0 of 27 |
| Intranasal Oxytocin | 0 of 27 |
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 |
|---|---|
| Placebo | 14 of 27 |
| Intranasal Oxytocin | 13 of 27 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Intranasal Oxytocin |
|---|---|---|---|
| Greater calmness | Nervous system disorders | 4 of 27 | 2 of 27 |
| Less anxiety | Nervous system disorders | 3 of 27 | 1 of 27 |
| Fatigue | General disorders | 1 of 27 | 1 of 27 |
| Lightheadedness | General disorders | 1 of 27 | 1 of 27 |
| Less flexibility | General disorders | 1 of 27 | 1 of 27 |
| Loss of appetite | General disorders | 1 of 27 | 1 of 27 |
| Headache | General disorders | 0 of 27 | 1 of 27 |
| Bloody nose | Injury, poisoning and procedural complications | 0 of 27 | 1 of 27 |
| Mouth pain | Injury, poisoning and procedural complications | 0 of 27 | 1 of 27 |
| Greater awakeness | General disorders | 0 of 27 | 1 of 27 |
The registry lists 27 participants at risk for serious adverse events in the placebo group and 27 in the intranasal oxytocin group. It records zero serious adverse events in each group. It also records zero deaths in each group. For other adverse events, the record lists 14 affected in the placebo group and 13 in the intranasal oxytocin group, with 27 at risk in each group.
These figures are counts in the registry record. They do not identify the types, timing, severity, or relatedness of the other adverse events; the record does not list top serious adverse event terms. The groups belong to a crossover study, but the registry information does not explain how adverse-event exposure or event attribution was handled across treatment periods. The counts should therefore be read as posted, not as an independently reconstructed comparison of risk between treatments.
Zero recorded serious adverse events does not establish that a treatment is free of risk. The adverse-event entries are a separate part of the record and do not answer the primary question about RMET performance. They also do not replace the missing primary outcome comparison.
12. What the Result Does, and Does Not, Mean
The record documents a randomized, quadruple-masked crossover study of single-dose intranasal oxytocin versus a saline nasal spray placebo in autism spectrum disorders. Its primary endpoint is the RMET total raw score, a social cognition task measure for which higher scores are described as better performance. These details establish what the study set out to compare and how its primary outcome was defined.
They do not establish whether scores were higher, lower, or similar between conditions. The registry record does not report primary outcome values, a treatment contrast, a confidence interval, or a p-value. Consequently, neither the direction nor the magnitude nor the precision of an effect can be described from the posted results. Enrollment of 27 participants does not fill that gap: enrollment is not the same as the number with usable outcome data, and it does not reveal the uncertainty around an estimate.
The endpoint measures performance on a particular task. It is not, by itself, a measure of every social behavior or of everyday functioning. Any interpretation would need to remain tied to the assessment and population studied, and to the analysis actually conducted. The registry record does not report enough outcome or analysis detail to make that interpretation for this trial.
The adverse-event entries report no serious adverse events or deaths in either group and report other adverse events in both. These observations provide limited descriptive safety information, but they do not establish a comparative safety profile. Taken together, the registry record describes the study design, endpoint, and some adverse-event counts, while leaving the central cognitive outcome result unreported. It therefore cannot establish that oxytocin improved performance, that it had no effect, or that any observed difference was clinically important.
13. Why This Trial Matters Statistically
This trial is statistically interesting because it uses a crossover design to study a task-based cognitive outcome. In such a design, comparisons can draw on measurements from the same participant under different conditions. That feature can help separate treatment-condition differences from stable variation between participants, provided the analysis reflects the paired structure and the design’s timing is appropriate.
The study also illustrates why a clearly defined endpoint and a reported estimate are both necessary for interpretation. The RMET outcome is described as a total raw score, with a defined direction and range. But an endpoint definition cannot substitute for observed values, an estimated contrast, and uncertainty. Without those results, readers cannot judge the size or precision of a possible difference, regardless of the study’s masking or randomization.
The registry’s limited reporting makes the distinction between a planned question and an answer especially important. The record identifies the comparison of oxytocin and placebo, but it does not report a single primary outcome comparison or any analyses. It also leaves the analysis population, missing-data handling, and crossover-specific statistical details unreported. These omissions prevent readers from assessing how design features were reflected in the analysis.
The adverse-event counts show another reason to keep outcomes distinct: event counts and task scores answer different questions. The former are descriptive safety entries; the latter would address the primary cognitive endpoint. Neither can stand in for the other. The trial’s statistical value to readers therefore lies in its documented design and endpoint, alongside the clear limits imposed by the absence of a posted primary result.
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 direct limitation of the available record is that it does not report the primary RMET scores or a treatment comparison. No effect estimate, confidence interval, or p-value is available for interpretation. The registry also lists zero analyses, leaving the statistical method used for the primary outcome unreported.
Important details for a crossover study are not reported: treatment order, the interval between sessions, washout arrangements, and whether the analysis considered period or carryover effects. The record does not state how many participants completed each condition or contributed outcome data. It also does not describe missing-data methods, the primary analysis population, or a trial-specific sample-size justification.
The registry lists three outcome measures but does not provide a single primary comparison. It does not report whether multiplicity was addressed, whether interim analyses occurred, or what statistical plan was followed. These details cannot be inferred from the trial’s phase, enrollment, or masking designation.
For safety, the record gives adverse-event counts but does not report the types, timing, severity, or relatedness of other adverse events. The design and record also do not provide enough detail to determine how the listed adverse-event groups correspond to exposure across crossover periods. These reporting limitations constrain interpretation; they do not establish that unreported procedures or analyses were absent from the conduct of the study.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Single Dose Intranasal Oxytocin and Cognitive Effects in Autism — NCT02493426.
- Registry record last updated 2023-01-23; status last verified 2023-01.
- Results first posted 2023-01-23.
- 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.
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18. Record Summary
NCT02493426 is a completed phase 2 randomized, quadruple-masked crossover study sponsored by the University of Minnesota. It enrolled 27 participants with autism spectrum disorders and compared a single dose of intranasal oxytocin with a saline nasal spray placebo. The primary outcome was the RMET total raw score, assessed with a stated timeframe of 2 weeks.
The registry record does not report primary outcome values, a single treatment comparison, or statistical analyses. It also does not report the analysis population, missing-data approach, sample-size justification, or key crossover details such as treatment sequence and washout. Safety entries list zero serious adverse events and zero deaths in each group, with other adverse events recorded in both groups. These entries do not provide the missing primary efficacy result.