An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia (NCT01939548), a randomized phase 2 study. The primary outcome is Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline.

2. Clinical Question

3. Trial Design

The registry describes a randomized, double-blind, parallel-group phase 2 study of PF-02545920 as adjunctive treatment for outpatients with sub-optimally controlled schizophrenia symptoms. The study title specifies a 12-week treatment period and two active dose groups, PF-02545920 5 mg BID and PF-02545920 15 mg BID, compared with placebo. The registry records enrollment of 240 and lists the study status as terminated.

The study began in 2013-10, with primary completion recorded as 2014-10. Those registry dates describe the study timeline; they do not establish why the study was terminated or whether termination occurred earlier than planned. The reason for termination is not reported in the registry record.

Randomization and double masking are design features intended to reduce systematic differences between groups and expectations that could influence assessment. In a parallel-group design, each assigned group is considered separately rather than participants crossing between treatments. The record does not report the allocation ratio, the randomization sequence method, who was masked, or how masking was maintained.

Although the brief description says the study would use PANSS to assess change from baseline, the primary outcome posted in the results is PANSS total score at baseline. No primary treatment-period change result is included in the registry record for this analysis. The registry record also does not report the original sample-size justification, the intended primary analysis, or whether any interim analyses were planned. These omissions limit how fully the study's original design and its treatment-effect question can be reconstructed from the registry entry.

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:

Analysis population for the primary outcome, as defined in the registry: All participants who received study treatment.

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.

Population: All participants who received study treatment were included in the baseline characteristics summary.

6. Primary Endpoint

The registry lists the primary outcome as Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline, measured over Baseline.

The Positive and Negative Syndrome Scale (PANSS) is described as measuring positive symptoms, negative symptoms, and general psychopathology associated with schizophrenia. It contains 30 items, with each item rated from 1 (symptom not present) to 7 (symptoms extremely severe). The total is the sum of those item ratings and ranges from 30 to 210; higher scores indicate greater symptom severity.

The registry's primary outcome is PANSS total score at baseline, reported as a mean with standard deviation among participants who received study treatment. A baseline measure can describe the groups' symptom severity before the treatment period and help readers understand the starting point for later change analyses. By itself, however, it is not a measure of improvement or worsening over time. It cannot show whether a treatment group changed from baseline, or whether its change differed from placebo.

The brief study description refers to measuring change in PANSS from baseline, but such a change measure is not the primary result posted in the record. The registry record does not report a primary PANSS change-from-baseline result or a later PANSS total score. This distinction is central to interpreting the posted primary outcome: it provides a baseline group description rather than an estimate of the intended treatment-period symptom contrast.

7. Results Posted in the Registry

• PF-02545920 5 mg BID: mean 81.70 versus 80.80 on control; difference 0.90 (95% CI -2.66 to 4.46), standardized effect d = 0.08; z-test p = 0.621.
• PF-02545920 15 mg BID: mean 82.50 versus 80.80 on control; difference 1.70 (95% CI -1.83 to 5.23), standardized effect d = 0.15; z-test p = 0.345.

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.

Clinical Global Impression - Improvement (CGI-I) Total Score at Week 12

• 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:
  • PF-02545920 5 mg BID: mean 2.90 versus 2.90 on control; difference 0.00 (95% CI -0.39 to 0.39), standardized effect d = 0.00; z-test p = 1.000.
  • PF-02545920 15 mg BID: mean 2.70 versus 2.90 on control; difference -0.20 (95% CI -0.60 to 0.20), standardized effect d = -0.22; z-test p = 0.333.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between PF-02545920 5 mg BID and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between PF-02545920 15 mg BID and the control. The interval gives the range of effects that remain compatible with the data.

Number of Participants With Laboratory Test Abnormalities

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • PF-02545920 5 mg BID: 61.3% (46/75) versus 62.8% (49/78) on control; risk difference -1.5 percentage points (95% CI -16.9 to 13.9), risk ratio 0.98 (0.76–1.25); unadjusted two-proportion z-test p = 0.850.
  • PF-02545920 15 mg BID: 66.7% (54/81) versus 62.8% (49/78) on control; risk difference 3.8 percentage points (95% CI -11.0 to 18.7), risk ratio 1.06 (0.84–1.34); unadjusted two-proportion z-test p = 0.612.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between PF-02545920 5 mg BID and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between PF-02545920 15 mg BID and the control. The interval gives the range of effects that remain compatible with the data.

Absolute Values of Movement Disorder Burden Score - Dystonia (MDBS-D) Over Active Treatment Period

• 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:
  • PF-02545920 15 mg BID: mean 0.02 versus 0.00 on control; difference 0.02 (95% CI -0.02 to 0.06), standardized effect d = 0.16; z-test p = 0.301.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between PF-02545920 15 mg BID and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcomes span clinician-rated global improvement, laboratory abnormalities, and movement-disorder burden, alongside the broader secondary outcome list that includes social functioning, PANSS subscales, and safety measures. The displayed results therefore cover different kinds of outcomes and different assessment periods. They are not all measuring the same underlying construct as baseline PANSS total score.

At a broad level, the secondary summaries do not fill the central gap in the primary results: the posted primary PANSS measure is at baseline, while the study description concerns symptom change during treatment. Some secondary outcomes are reported at Week 12 or over the active treatment period, but these do not become a substitute for a reported primary PANSS change estimate. The outcomes may help characterize other aspects of the trial, but their interpretation remains specific to their own measure, time point, and analysis population.

Unadjusted secondary results carry less weight as a collection because the registry lists many outcome measures and analyses. When many outcomes are examined, some results can appear notable by chance even if no underlying effect exists. The registry record does not report whether multiplicity was controlled, whether a hierarchy of outcomes was prespecified, or which secondary comparisons were intended as confirmatory. Their findings are therefore best treated as exploratory or descriptive unless an analysis plan establishes otherwise.

Counts available for a given secondary outcome can differ from the baseline group summaries. The reason for those differences and the handling of missing follow-up measurements are not reported in the registry record. Readers should interpret each secondary result in its own denominator and avoid combining endpoints into a single overall judgment.

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

• Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Total Score
• Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales
• Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores
• Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)
• Clinical Global Impression - Improvement (CGI-I) Total Score at Week 12
• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)
• Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
• Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: PANSS total score is a numerical scale, and the registry reports each group's mean and standard deviation. A mean describes the group's average score, while a standard deviation describes how spread out individual scores are around that average. The two summaries answer different questions. Similar means can coexist with substantial variation among participants, and the standard deviation is not the uncertainty interval for the group mean.

The comparison figures are simple unadjusted re-calculations from the posted group summaries. A mean difference expresses the active-group mean relative to the placebo mean, using the order stated for each comparison. A positive value means the active-group mean was higher at baseline; a negative value would mean it was lower. Since higher PANSS scores indicate greater severity, the sign has a scale interpretation, but these are baseline contrasts, not contrasts in change during treatment.

A confidence interval gives a range of estimates compatible with the data and the method used to construct the interval. For the baseline comparisons, both reported 95% intervals cross zero. In general, when a confidence interval for a difference includes zero, the data are compatible with no difference as well as with differences in either direction within the interval. That does not prove the groups are identical. The interval's width also matters: wider intervals indicate less precision about the size and direction of the contrast.

The reported p-values for these primary comparisons are unadjusted. A p-value describes how unusual data at least as incompatible with a specified null model would be, under the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not measure clinical importance. Because these are unadjusted calculations from summary statistics, they should not be confused with a sponsor-reported model-based treatment analysis. The registry record does not report an inferential primary analysis of PANSS change.

For general statistical context, an unadjusted two-group comparison does not account for covariates or other design features unless those are explicitly incorporated. The original adjustment strategy is not reported in the registry record. The planning illustrations are also distinct from the trial's reported estimates: they use a normal approximation, equal allocation between two arms, a two-sided significance level of 0.05, and an effect set to a stated fraction of the observed effect. These are stated planning assumptions, not a description of the trial's original design calculations.

Several secondary outcomes are continuous, such as the CGI-I total score and the movement-disorder scale measure. Their group summaries are means and standard deviations; their comparisons are mean differences. Other outcomes are counts of participants, such as laboratory abnormalities. A risk difference compares the proportion with the event in one group with the proportion in the other. In general, proportions and risk differences depend on both the event count and the denominator, so denominators should be read alongside the counts.

For general statistical context, binary outcomes may also be expressed using a risk ratio or odds ratio, but those measures are not interchangeable with a risk difference. The posted tables include several forms of comparison for some binary outcomes. Their uncertainty intervals can be broad, and interpretation should consider the event counts and denominators rather than focusing on one point estimate.

Over-dispersion is a general concern when count data vary more than a model assumes; it can make model-based standard errors too small if ignored. No count-model analysis for over-dispersion is described in the registry record. That issue does not alter the interpretation of the posted continuous PANSS baseline summaries, but it illustrates why the analysis method should be matched to the type and distribution of each outcome.

The record lists the primary analysis population as all participants who received study treatment. It does not report enough detail to determine how missing observations were handled, whether all randomized participants were included in every outcome analysis, or how the analyses were adjusted. Those decisions can affect estimates, particularly for outcomes measured after baseline. The posted baseline results should therefore be read as descriptive summaries with simple unadjusted comparisons, not as a complete account of the original statistical analysis plan.

11. Confidence Intervals and Precision

The baseline mean-difference estimates are 0.9 for PF-02545920 5 mg BID versus placebo and 1.7 for PF-02545920 15 mg BID versus placebo. Their 95% confidence intervals are -2.665 to 4.465 and -1.827 to 5.227, respectively. Each interval includes zero, leaving uncertainty about the direction and size of the baseline difference. The intervals do not demonstrate that the group means are exactly equal.

Precision is about how tightly an estimate is located, not whether its value is important. A confidence interval gives a range of values compatible with the data and statistical method; it is not a guarantee that the true value lies within that particular interval. The standard deviations describe variation among participants, while the confidence intervals describe uncertainty in the group contrast. They should not be interpreted as the same quantity.

These intervals concern baseline scores only. They cannot be used to judge precision for a treatment-period change because the registry record does not report the corresponding primary change estimate. The posted p-values are also unadjusted re-calculations from summary statistics, rather than a replacement for an original model-based primary analysis, which is not reported in the registry record.

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.

The sample-size illustrations express required numbers as participants per arm for 80% power or participants per arm for 90% power. They are not total sample sizes and are not counts of total events. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect set to the stated fraction of the observed effect. For time-to-event outcomes, the stated convention would instead be total events, but these illustrations are participant-per-arm figures.

The 80% power column describes a planning scenario in which the assumed effect would be detected by the specified test in 80% of repeated studies under the assumptions used. The 90% column uses a higher probability of detection under those same assumptions. Greater planned power generally requires more participants for a given assumed effect. Smaller effects need more participants because they are harder to distinguish from random variation.

The rows for a stated fraction of the observed effect let readers see how the planning requirement changes if the effect to detect is smaller than the observed estimate. These are planning illustrations computed from the observed effect, not the trial's original sample-size justification; that original justification is not reported in the registry record. They are not observed power. The registry's enrollment figure and the numbers used in outcome summaries should not be interpreted as validating these illustrations or as evidence that the trial was adequately powered for a treatment-period endpoint.

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 = 0.900; pooled standard deviation σ = 11.424.
2. n = 2 × (1.96 + 0.842)² × 11.424² / 0.900² = 2,529.4, rounded up to 2,530 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 <- 0.900000000000006                      # observed difference in means
sigma <- 11.4244040129576                     # 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(1939548)
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 = 2,530 (80% power), 3,387 (90% power)
 75% of observed effect: n per arm = 4,497 (80% power), 6,020 (90% power)
 50% of observed effect: n per arm = 10,118 (80% power), 13,545 (90% power)
power.t.test: 2530.4 
Simulated power at n = 2,530 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 multiple secondary outcomes and analyses, but the approach to multiplicity is not reported in the registry record. It is therefore not possible to determine whether the study used an adjustment for testing multiple outcomes, a prespecified hierarchy, or another strategy to distinguish confirmatory from exploratory analyses. Unadjusted p-values across many outcomes do not have the same interpretation as a single prespecified test; repeated testing increases the chance of at least one apparently unusual result by chance.

The missing-data strategy is also not reported in the registry record. The available summaries do not establish whether missing observations were excluded, imputed, handled by a repeated-measures model, or treated in another way. Reasons for missing follow-up data and their distribution across treatment groups are not reported. This matters especially for outcomes measured after baseline, because the available observations may not represent all participants who began treatment.

The primary outcome population is described as all participants who received study treatment. The record does not report whether that population corresponds to all randomized participants, nor does it state the analysis population used for each secondary outcome. It also does not report an intention-to-treat analysis definition, a per-protocol population, or the rules for including participants in individual analyses.

The statistical plan for the original primary treatment comparison is not reported in the registry record. In particular, the record does not specify the planned model, covariate adjustment, treatment contrast, missing-data assumptions, or interim-analysis approach. The baseline re-calculations are consequently useful as descriptive comparisons, but they should not be presented as a reconstruction of the original treatment-effect analysis.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: acute myocardial infarction (1.3%), paranoia (1.3%), intestinal obstruction (1.2%), alcohol poisoning (1.2%), injury (1.2%).

The serious adverse event summaries report 2 participants in the PF-02545920 5 mg BID group, 0 in the 15 mg BID group, and 6 in the placebo group with serious adverse events. The corresponding numbers at risk are 78, 82, and 80. The registry also lists other adverse events in each group; these counts are separate from the serious adverse event counts and should not be conflated with them.

The record lists serious-event terms with percentages, including acute myocardial infarction and paranoia at 1.3%, and intestinal obstruction, alcohol poisoning, injury, and toxicity to various agents at 1.2%. These entries do not establish that study treatment caused the events, and they should not be treated as comparative group-specific risks without the relevant context and denominators.

Deaths are not reported in the registry record. The summaries do not by themselves establish comparative safety, particularly because event counts are limited and the registry does not report further detail about event timing, attribution, exposure duration, or the analysis method.

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

The posted primary outcome supports a limited conclusion about the recorded baseline PANSS scores: the group means were close in scale terms, and the simple unadjusted comparisons have confidence intervals that include zero. Those statistics describe baseline differences and their uncertainty. They do not show that PF-02545920 improved symptoms, failed to improve symptoms, or differed from placebo during the treatment period.

The distinction between baseline and change is important. A baseline score is measured before the intervention can produce a treatment-period response. To assess change, an analysis would need a follow-up score, a change-from-baseline measure, or an appropriate longitudinal comparison. Such a primary result is not reported in the registry record, even though the study description says PANSS would be used to measure change.

The posted secondary and safety results offer additional information about the outcomes recorded, but they do not resolve the missing primary treatment-period comparison. Secondary analyses may be affected by multiplicity, missing follow-up observations, and analysis-population choices; those details are not reported in the registry record. Safety counts should similarly be read as event summaries rather than proof of causation or a complete assessment of risk.

The registry lists the study as terminated, but the reason is not reported. Termination does not, by itself, indicate the direction or quality of the results. Nor should the planning illustrations be treated as evidence that the study was underpowered or that a particular effect exists: they are hypothetical sample-size calculations based on the observed estimates and stated assumptions, not the original design rationale.

Accordingly, the available record is informative about the trial's design, baseline PANSS summaries, selected secondary results, and adverse-event counts. It does not support a definitive conclusion about the efficacy of either dose on the treatment-period PANSS question. Such a conclusion would require relevant treatment-period estimates and their analysis details.

17. Why This Trial Matters Statistically

This trial illustrates why the name and timing of an endpoint matter as much as its measurement scale. The stated study aim focuses on evaluating symptom change over treatment, yet the primary outcome posted in the registry is PANSS total score at baseline. A well-known clinical scale can be measured accurately while still answering a different question from the one readers expect when they see a treatment-efficacy study.

It also shows why estimates need context. A mean difference and confidence interval can be calculated from group summaries, but the resulting comparison remains tied to the time point and analysis represented by those summaries. Baseline contrasts are not treatment effects. A p-value cannot repair that mismatch, and statistical significance is not a substitute for identifying the clinical question an endpoint actually addresses.

The record further highlights the role of transparent analysis plans. With multiple outcomes, different assessment times, and unreported details about multiplicity and missing data, readers have limited ability to distinguish confirmatory findings from exploratory ones. Clear reporting of planned populations, estimands, models, and missing-data handling would make the evidence easier to assess.

Finally, planning illustrations can demonstrate how assumptions about effect size influence the number of participants needed, but they cannot stand in for the trial's original justification. This distinction helps prevent retrospective calculations from being mistaken for design evidence or observed power. The statistical lesson is to keep endpoint, analysis, and interpretation aligned.

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 most important limitation of the posted primary results is that they describe PANSS at baseline, whereas the study description refers to change during treatment. A primary treatment-period PANSS estimate and its analysis are not reported in the registry record. Thus, the posted primary result cannot directly answer the central efficacy question stated in the study description.

The registry lists the trial as terminated, but does not report why. It records enrollment of 240, while participant counts vary across outcome summaries. Those counts should be read in the context of each outcome; the reasons for differing analysis counts, including any missing follow-up information, are not reported in the registry record.

The record does not report the original sample-size justification, the full statistical analysis plan, multiplicity procedures, or missing-data methods. The simple unadjusted calculations are not substitutes for an original model-based analysis. They also do not account for any covariate adjustment or other design features that may have been in a planned analysis.

Some secondary outcomes are reported at particular follow-up periods, but their populations and analysis details are not fully described. The record also does not give further context for adverse-event timing or attribution, and deaths are not reported in the registry record. These limitations constrain both efficacy and safety interpretation without establishing that any particular treatment effect or harm occurred.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia — NCT01939548.
• Registry record last updated 2016-08-22; status last verified 2016-07.
• Results first posted 2016-08-22.
• 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

The registry describes a randomized, double-blind, parallel-group phase 2 outpatient study of PF-02545920 5 mg BID and 15 mg BID versus placebo for sub-optimally controlled schizophrenia symptoms. The study period is described as 12 weeks; enrollment is recorded as 240, and status is terminated.

The primary outcome posted is baseline PANSS total score. The registry describes PANSS as a 30-item scale ranging from 30 to 210, with higher scores indicating greater severity. The posted baseline comparisons are unadjusted calculations and do not estimate treatment-period change. Although the study description refers to PANSS change, that primary change result is not reported in the registry record.

Secondary outcomes and adverse-event summaries are also recorded. The reason for termination, the original sample-size justification, and key details of the statistical and missing-data plans are not reported in the registry record.