Does Acute Oxytocin Administration Enhance Social Cognition in Individuals With Schizophrenia?: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Does Acute Oxytocin Administration Enhance Social Cognition in Individuals With Schizophrenia? (NCT01312272), a randomized na study. The primary outcome is Social Cognition Composite Measure.

2. Clinical Question

The motivating hypothesis was that acute intranasal oxytocin might improve social cognition in individuals with schizophrenia. The registry describes social cognition as functions engaged during social interactions and notes its relevance to community functioning. The primary endpoint combined four social-cognition measures, including measures characterized as high-level and low-level. Results should be read as a comparison of mean changes on that composite, not as a direct measure of all social functioning or community outcomes.

The primary outcome timeframe was Visit 2 at baseline and Visit 3 one week following treatment. The registry does not report a threshold that would define a clinically important change in the composite. Nor does it report further details of eligibility, the exact timing of the acute dose relative to each assessment, or the intended role of each masking group. Those details are not needed to describe the posted comparison, but they limit how specifically the study question can be framed.

3. Trial Design

The study is listed as completed and randomized, with a parallel-group model and triple masking. Its enrollment is listed as 24. The sponsor was VA Greater Los Angeles Healthcare System. The registry lists the study phase as NA. The record gives a start date of 2011-04 and a primary completion date of 2012-08.

One group received intranasal oxytocin and the other received inactive nasal spray. The active regimen is described as one intranasal dose of 40 IU; the listed concentration is 40 units/ml. The inactive spray was described as lacking oxytocin while otherwise matching the active nasal spray, with mannitol, glycerin, and preserved water listed as its ingredients. Although the record says triple masking, it does not identify which participants, researchers, assessors, or other roles were masked. Further information about sequence generation, allocation concealment, treatment administration, or protocol adherence is not reported in the registry record.

The primary outcome was assessed at baseline and one week following treatment. The registry reports arm-level primary outcome summaries for 12 participants in the inactive-spray group and 11 in the oxytocin group. The registry enrollment count and these outcome-specific counts are different descriptions of the study; the record does not explain the relationship between them. It does not report the analysis population, reasons for any difference in available outcome counts, or whether missing outcome data were imputed.

The registry names five secondary outcomes: theory of mind, empathy, social perception, facial affect recognition, and the Positive and Negative Syndrome Scale total score. Numerical arm summaries are posted for three of those secondary outcomes. Results for the other two are not reported in the registry record. The registry record does not report the trial's original sample-size justification, a detailed statistical analysis plan, or whether any interim analyses were planned or conducted.

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

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 Social Cognition Composite Measure, measured over Visit 2 (baseline), Visit 3 (1 week following, post-treatment).

The primary endpoint is the Social Cognition Composite Measure, described as change in z-score between baseline at Visit 2 and Visit 3 one week following treatment. A z-score expresses a measure relative to a mean and standard deviation, allowing measures with different scales to contribute to a common composite. The study description says that four main social-cognition measures were used: two high-level and two low-level measures.

For each measure, the study description says scores were centered and scaled using the baseline mean and standard deviation of the whole sample. The four resulting z-scores were then averaged to create the composite at each time point. The primary endpoint therefore combines information across the four measures rather than relying on any one measure alone. This approach is useful when the component measures are on different scales and the research question concerns a broader construct represented by all of them.

The reported outcome is a mean change in the composite. A positive value indicates an increase in the standardized composite score over the stated timeframe; the registry does not provide a threshold for interpreting the size of a change as important. The posted arm means are 0.1 for inactive nasal spray and 0.23 for intranasal oxytocin. The unadjusted mean difference is 0.13, comparing oxytocin with inactive spray. The endpoint describes measured score change; by itself, it does not establish what that change means for daily functioning or for any individual participant.

7. Results Posted in the Registry

• Intranasal Oxytocin: mean 0.23 versus 0.10 on control; difference 0.13 (95% CI -0.16 to 0.42), standardized effect d = 0.37; z-test p = 0.381.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Theory of Mind Assessment (High Level Social Cognition)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Intranasal Oxytocin: mean 0.18 versus -0.01 on control; difference 0.19 (95% CI -0.37 to 0.75), standardized effect d = 0.29; z-test p = 0.504.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intranasal Oxytocin and the control. The interval gives the range of effects that remain compatible with the data.

Empathy

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Intranasal Oxytocin: mean 0.61 versus 0.24 on control; difference 0.37 (95% CI -0.20 to 0.94), standardized effect d = 0.53; z-test p = 0.206.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intranasal Oxytocin and the control. The interval gives the range of effects that remain compatible with the data.

Social Perception Assessment (Low Level Social Cognition)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Intranasal Oxytocin: mean 0.00 versus 0.15 on control; difference -0.15 (95% CI -0.76 to 0.46), standardized effect d = -0.20; z-test p = 0.632.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intranasal Oxytocin and the control. The interval gives the range of effects that remain compatible with the data.

The registry names five secondary outcomes: theory of mind, empathy, social perception, facial affect recognition, and PANSS total score. Numerical arm summaries and unadjusted comparisons are posted for theory of mind, empathy, and social perception. Results for facial affect recognition and PANSS total score are not reported in the registry record. The secondary results that are available do not form a uniformly positive pattern: some point estimates favor higher change with oxytocin, while another favors higher change with inactive spray. Their confidence intervals include zero, and their unadjusted p-values do not establish clear group differences.

That mixed direction is broadly consistent with the primary result in one important respect: the posted summaries do not provide a precise, consistent separation between groups across the measured outcomes. It does not prove that there was no effect, nor does it show that every component of social cognition behaves the same way. The primary composite and the separate secondary measures address related but nonidentical aspects of cognition and symptoms. Their results should not be combined informally into a single overall claim.

Unadjusted secondary results carry less weight because several outcomes are examined. General statistical explanation: when many hypotheses are tested, the chance of seeing at least one apparently unusual result can increase even if there is no underlying effect. A multiplicity procedure can address that issue, but the registry record does not report such a procedure or a prespecified hierarchy for the secondary outcomes. Thus, individual secondary p-values are exploratory descriptions rather than a reliable basis for declaring a distinct effect.

The available secondary summaries can help show whether the primary pattern appears alongside related measures, but incomplete numerical reporting and uncertain multiplicity handling limit that role. No conclusion about the two secondary outcomes without posted numerical results can be drawn from the fact that they are named in the registry.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Theory of Mind Assessment (High Level Social Cognition)
• Empathy
• Social Perception Assessment (Low Level Social Cognition)
• Facial Affect Recognition (Low Level Social Cognition)
• Positive and Negative Syndrome Scale (PANSS) for Schizophrenia Total Score

9. Statistical Interpretation

10. Statistical Methods Explained

The statistical quantities in the posted results describe continuous outcomes. For a continuous measure, an arm mean summarizes the average value among participants with available results, while a standard deviation describes how spread out individual measurements are around that mean. These summaries are descriptive: they do not show the full distribution of scores or reveal whether an average is driven by a few unusually high or low values.

What does a mean difference represent?

The primary comparison is the mean change in the oxytocin group minus the mean change in the inactive-spray group. The posted means are 0.23 and 0.1, respectively, and the resulting difference is 0.13. A positive difference indicates a higher average change in the oxytocin group on this outcome. The direction describes the comparison as coded; it does not by itself establish a meaningful benefit or a causal effect.

General statistical explanation: a difference in means is an estimate of the contrast between group averages. It is expressed in the outcome's units, which for this primary endpoint are change in z-score. A standardized composite has a scale defined by the scoring procedure, so interpretation should remain tied to that construction. The registry record does not report a threshold for a clinically important difference.

How should the confidence interval be read?

General statistical explanation: a confidence interval describes the uncertainty associated with an estimate under the assumptions of the method used to construct it. A wider interval indicates less precision; an interval that includes zero is compatible with no average difference as well as with differences on either side of zero. The primary interval includes zero. Its exact endpoints are not needed to understand that feature, and the registry record does not state a threshold that would distinguish a clinically meaningful difference from a small one.

General statistical explanation: a confidence interval is not a range containing a known proportion of individual participants' outcomes. It concerns uncertainty in the estimated group contrast. It also does not correct for design limitations or account automatically for analyses that were not reported. Here, the registry record does not identify the inferential method used in an original sponsor analysis, so the interval should be read as part of the unadjusted summary-based comparison.

What does the p-value add?

The unadjusted p-value for the primary comparison is 0.381. General statistical explanation: a p-value describes how unusual data at least as incompatible with a specified null hypothesis would be under a statistical model in which that null hypothesis is true. It is not the probability that the null hypothesis is true, the probability that a result occurred by chance, or a measure of clinical importance. It should be considered alongside the estimated difference and its interval, rather than used alone to label the result.

The word unadjusted matters because the value does not account for testing multiple outcomes or comparisons. The registry record does not report a multiplicity adjustment or a detailed analysis plan. The record also lists no reported analyses in its analysis listing. Accordingly, the unadjusted p-value should not be treated as a complete account of the trial's statistical procedure.

Why do standard deviations and sample size matter?

General statistical explanation: the variability of scores and the number of observations both influence the precision of a group comparison. Greater variability tends to make it harder to estimate a mean difference precisely, while more observations generally allow a more stable estimate. The primary arm summaries report standard deviations of 0.35 and 0.36, with 12 and 11 participants, respectively. Those summaries help explain why the comparison carries considerable uncertainty, but they do not reveal the score distribution or any possible effects of missing observations.

The registry record describes the primary composite as an average of four standardized measures. Standardization is intended to put component scores on a common scale before combining them. General statistical explanation: averaging components can represent a broader construct, but interpretation depends on the measures chosen and the scoring procedure. The record does not report component weights other than describing an average, nor does it report an assessment of how well the composite measures the intended construct.

What does over-dispersion mean in general?

General statistical explanation: over-dispersion arises when observed variability is larger than a model assumes. It can make standard errors too small and statistical evidence appear more certain than it is if the model does not allow for the extra variability. Over-dispersion is mainly a concern for outcomes such as counts and event rates, rather than a default description of a continuous composite mean. The primary outcome is continuous, and the registry record does not report a model check or an over-dispersion assessment. It would therefore be inappropriate to claim that over-dispersion was present or that a particular adjustment was used.

The distinctions among the estimate, its uncertainty, and the p-value are useful for reading these results. The estimate gives the direction and size of the observed average contrast, the confidence interval conveys its precision, and the p-value relates the data to a null hypothesis under statistical assumptions. None of these quantities alone resolves questions about missing data, multiplicity, the original analysis plan, or the clinical meaning of the composite change.

11. Confidence Intervals and Precision

The primary mean difference is 0.13, with an unadjusted confidence interval that includes zero. This means the posted estimate is not precise enough to rule out no average difference under the interval's statistical assumptions. Because the interval extends to both positive and negative differences, the result also leaves uncertainty about the direction of the underlying average contrast. The unadjusted p-value is 0.381, which is consistent with the interval's lack of a clear separation from zero.

Precision is limited in part by the small outcome-specific groups: 12 participants contributed to the inactive-spray summary and 11 to the oxytocin summary. The standard deviations are 0.35 and 0.36. General statistical explanation: when there are few observations and individual scores vary, estimates of the group means and their difference tend to be uncertain. The interval is therefore more informative than the positive point estimate alone.

The interval addresses uncertainty in the average difference, not the range of possible individual responses. It also does not indicate whether a difference would matter in practice. The registry record does not report a clinically important threshold, a precision target, or the original sample-size justification. Without those details, the result cannot be evaluated against a stated target for useful precision.

The interval and p-value are unadjusted. The registry record does not report whether the primary comparison was adjusted for other variables or whether the analysis accounted for the set of secondary outcomes. These limits do not change the numerical result; they affect how completely the registry record documents the inferential context. The most defensible interpretation is that the estimated difference is positive but uncertain, and that the posted results do not establish a precise direction or magnitude.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

Each planning figure refers to participants per arm, not total events. The planning assumptions listed for these illustrations are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set as the stated fraction of the observed effect: 100%, 75%, or 50%. These are planning illustrations computed from the observed effect, rather than the trial's original design assumptions, which are not reported in the registry record.

The 80% power column gives the estimated participants per arm for a design that would have an 80% chance of detecting the specified effect under the listed assumptions, if that effect were the true one and the model assumptions held. The 90% power column gives the corresponding planning target for a 90% chance. In either case, power is a property of a hypothetical design under specified assumptions; it is not a measure of what happened in this completed study. These figures are not observed power.

The effect fractions are anchored to the effect observed in this small trial. They should not be treated as established estimates of an effect likely to recur in another study. Smaller target effects require more participants per arm to reach the same planned power, because a smaller difference is harder to distinguish from random variation. The planning values are therefore sensitive to the observed effect used as their starting point. The registry record does not report an independent target effect or the trial's original sample-size justification, so these illustrations should not be read as evidence about the adequacy of the original enrollment.

General statistical explanation: a planning curve relating effect size to sample size shows the same trade-off: detecting a smaller difference while maintaining a chosen power generally requires a larger planned sample. Such calculations depend on the assumed variability, allocation, significance level, and analysis method. The registry's stated assumptions identify a normal approximation and equal allocation, but do not supply a separate design rationale for this trial.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.130; pooled standard deviation σ = 0.355.
2. n = 2 × (1.96 + 0.842)² × 0.355² / 0.130² = 116.9, rounded up to 117 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.13                      # observed difference in means
sigma <- 0.354797058021839                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1312272)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 117 (80% power), 157 (90% power)
 75% of observed effect: n per arm = 208 (80% power), 279 (90% power)
 50% of observed effect: n per arm = 468 (80% power), 627 (90% power)
power.t.test: 117.9 
Simulated power at n = 117 per arm: 0.800 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The record lists one primary composite and five secondary outcomes, creating multiple possible outcome comparisons. The registry record does not report a multiplicity adjustment, a testing hierarchy, or a statistical analysis plan explaining how the primary and secondary tests were to be interpreted together. The p-values associated with the posted comparisons are unadjusted. They should therefore be read as outcome-specific summaries, not as evidence that the probability of a false positive across all tested outcomes was controlled.

The registry record does not report interim analyses or whether any interim decision rules were planned or used. It also does not report whether outcomes were selected for posting according to a prespecified plan. These omissions do not establish that particular procedures were absent; they mean the record does not document them. The primary result remains the main comparison identified by the record, while the secondary results warrant greater caution because they are multiple and unadjusted.

Missing-data handling is also not reported in the registry record. The enrollment count is 24, while the primary arm summaries include 12 and 11 participants. The record does not explain why those outcome counts differ from the enrollment count, whether any participants lacked an outcome, or how such cases were handled. No imputation method, sensitivity analysis, or missingness assessment is reported. It would be inappropriate to infer either the cause or the consequences of the difference in counts.

The analysis population is not reported in the registry record. It is not stated whether the posted summaries represent all randomized participants, participants who completed treatment, participants with observed endpoint data, or another group. The record also does not report an intention-to-treat analysis or a per-protocol analysis. These details matter because the population included and the handling of missing values can affect the interpretation of a randomized comparison. The posted group summaries remain useful descriptions, but the analytic population and the assumptions behind it cannot be reconstructed from the registry record.

15. Safety Results

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

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 serious adverse event figures show 0 serious adverse events among the 12 participants listed at risk in the inactive-spray group and 0 among the 11 listed at risk in the oxytocin group. These figures describe the serious adverse events recorded for the groups in the registry entry; they do not establish that no serious event could occur, or that the groups have equivalent safety profiles. The number of participants is limited, and the record does not give further details about safety monitoring or the period covered by the adverse-event summaries.

For other, non-serious adverse events, the record lists 2 affected participants in each group: 2 of 12 in the inactive-spray group and 2 of 11 in the oxytocin group. These are counts of affected participants, not counts of all event episodes. The registry record does not identify the specific non-serious events in these summaries. It also does not report death counts; those figures are not reported in the registry record.

These numbers should be read as descriptive reporting, not as a formal comparison of safety risks. A zero count in a small group is compatible with uncertainty about uncommon events, and the posted record does not provide an inferential safety analysis.

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

The primary result is a positive unadjusted mean difference of 0.13 in change on the social-cognition composite, comparing intranasal oxytocin with inactive nasal spray. The interval includes zero, and the unadjusted p-value is 0.381. Taken together, these statistics describe an estimated group difference with substantial uncertainty; they do not establish a clear difference between the groups.

Equally, the result should not be read as proof that the groups were the same. A nonsignificant or uncertain comparison can arise when an effect is small, when measurements vary, or when the available sample is too limited to estimate the contrast precisely. The record does not provide enough information to distinguish among those possibilities. It also does not provide a clinically important threshold that would allow the point estimate or its uncertainty to be judged against a practical benchmark.

The result concerns an average change in a standardized composite measured at baseline and one week following treatment. It does not establish whether any change persisted beyond that visit, generalized to everyday social interactions, or reflected improvement in any one component measure. It cannot be used to infer how an individual participant would respond. The registry record does not report individual-level results or a longer-term outcome for this endpoint.

The study's hypothesis and design address acute intranasal administration in individuals with schizophrenia, but the posted outcome summary is not a complete account of all planned analyses. The analysis population, original statistical plan, missing-data handling, and multiplicity procedure are not reported in the registry record. Those gaps limit the strength and scope of interpretation.

Overall, the posted data support a cautious description: the average primary composite change was higher in the oxytocin group than in the inactive-spray group, but the estimated difference is imprecise and the comparison does not establish a group separation. This statistical interpretation is not a treatment recommendation and does not answer broader questions about clinical benefit or harm.

17. Why This Trial Matters Statistically

This trial is statistically instructive because it illustrates the difference between a point estimate and the evidence supporting that estimate. The primary mean difference is positive, but the confidence interval includes zero and the unadjusted p-value is 0.381. Looking only at the direction of the point estimate would overlook how uncertain the comparison remains. Reading the estimate alongside its interval gives a fuller account of what the posted data can and cannot resolve.

The endpoint also demonstrates how a composite can place measures on different scales into one outcome. The registry describes centering and scaling each component using baseline sample statistics, then averaging the four z-scores. This creates a common metric for summarizing several social-cognition measures, while making interpretation dependent on the selected components and the standardization procedure. The record does not report a threshold for a meaningful composite change.

The small outcome-specific groups make precision especially important. The planning illustrations show how sample-size needs depend on the target effect and stated assumptions, while not documenting the original design rationale. That distinction prevents a planning calculation based on an observed effect from being mistaken for evidence that the completed trial was adequately powered or that a particular effect size is reliable.

Finally, the record highlights why transparent reporting matters. Without documented analysis populations, missing-data methods, multiplicity handling, or an original analysis plan, readers cannot fully assess how the posted summaries relate to the intended analysis. Those uncertainties do not erase the descriptive results, but they define the limits of conclusions that can be drawn from them.

18. 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 outcome-specific primary summaries include 12 participants in one arm and 11 in the other, while enrollment is listed as 24. The registry record does not explain this difference or report the analysis population. As a result, it is not possible to determine from the registry record how many randomized participants contributed to each analysis, why any outcome data may be absent, or how the available-case summaries relate to the original randomized groups.

The primary comparison is unadjusted and the registry record does not report a detailed analysis plan, covariate adjustment, or inferential method used by the sponsor. It also does not report whether the data were examined under alternative assumptions. The reported interval and p-value are therefore best interpreted as unadjusted calculations based on the posted arm summaries, rather than as a fully documented trial analysis.

The sample is small, and the resulting primary interval includes zero and differences in either direction. The record does not provide a clinically important difference threshold, a prespecified target effect, or the original sample-size justification. Thus, neither the practical importance of the estimated difference nor the study's intended precision can be evaluated against a stated benchmark.

The primary outcome combines four measures, but the registry record does not report evidence about the composite's measurement properties or the contribution of each component to the overall result. Five secondary outcomes are named, while numerical results are posted for three; this incomplete reporting limits a broader assessment across related domains. The record also does not report multiplicity handling for the several outcomes.

Finally, the endpoint timeframe is limited to baseline and one week following treatment. Longer-term results for the primary outcome are not reported in the registry record. The record does not describe further details of masking roles, allocation procedures, or protocol adherence, which limits assessment of those design features.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Does Acute Oxytocin Administration Enhance Social Cognition in Individuals With Schizophrenia? — NCT01312272.
• Registry record last updated 2014-05-02; status last verified 2014-03.
• Results first posted 2014-05-02.
• 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.

22. Record Summary

This completed randomized, triple-masked, parallel-group study compared a single intranasal oxytocin dose with inactive nasal spray in individuals with schizophrenia. The registry lists enrollment of 24. Its primary endpoint was change in a social-cognition composite from baseline to one week following treatment.

The posted primary group means were 0.1 for inactive spray and 0.23 for oxytocin, with an unadjusted mean difference of 0.13. The unadjusted p-value was 0.381, and the confidence interval includes zero. The result is therefore an uncertain estimate rather than a clear separation between groups.

Numerical summaries are posted for three named secondary outcomes; results for the other two are not reported in the registry record. The record does not report the original sample-size justification, detailed analysis plan, analysis population, missing-data handling, or multiplicity procedure. Serious adverse event counts were 0 in each group. Overall, the registry supports a descriptive account of a small, short-term comparison but leaves important aspects of analysis and precision undocumented.