Escitalopram to Placebo in Patients With Localized Pancreatic Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Escitalopram to Placebo in Patients With Localized Pancreatic Cancer (NCT05289830), a randomized phase 2 study. The primary outcome is Change in the Rate of Depression.

2. Clinical Question

The clinical question concerns depression symptoms during cancer treatment, not a tumor response endpoint. The registry describes use of antidepressants in participants with localized pancreatic and periampullary cancer receiving neoadjuvant therapy. It specifies a 12-week assessment for the primary outcome, but does not report a complete set of evaluable outcome data at that time.

The posted primary result has a value for one participant receiving escitalopram and no value for the placebo group. The record also states that 1 participant in Arm 1 and 2 participants in Arm 2 were not evaluable at 12 weeks and did not complete the study. As a result, the posted data do not permit a meaningful estimate of the difference between the two groups. They also do not establish a group-level change from baseline.

3. Trial Design

This was a randomized, parallel-group Phase II trial comparing escitalopram with placebo. The registry lists enrollment of 4 participants. The trial record gives a start date of 2022-08-05, a primary completion date of 2023-08-27, and a status of terminated. The reason for termination is not reported in the registry record.

The official title describes the study as double-blind, while the structured masking entry says single. The record does not specify who was masked, so the difference between those descriptions cannot be resolved from the registry information. The allocation is listed as randomized, but the randomization method, concealment procedures, and intended allocation ratio are not reported in the registry record.

The listed intervention groups were participants receiving escitalopram and participants receiving placebo. Arm descriptions do not add details about treatment administration. The record identifies neoadjuvant therapy as the treatment context but does not report the cancer-treatment regimens, the timing of study treatment relative to those regimens, or whether those aspects were standardized across participants.

The primary completion date is a registry milestone; it does not mean that the planned outcome data were complete or that a between-group analysis was available. No statistical analyses are posted. The registry record does not report a sample-size justification, planned interim analyses, or a detailed statistical analysis plan. Accordingly, the design description establishes the broad comparison and setting, but not the full operational or analytical methods.

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: 1 participant in Arm 1 and 2 participants in Arm 2 were not evaluable at 12 weeks and did not complete the 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 Change in the Rate of Depression, measured over 12 weeks from the start of treatment.

The primary endpoint is titled “Change in the Rate of Depression” and uses the Quick Inventory of Depressive Symptoms (QIDS) score at 12 weeks from the start of treatment. The QIDS survey has 16 questions about depression symptoms. Responses use a four-point Likert scale from 0 to 3. The survey is divided into 9 domains, and the total score is calculated by adding the highest score from any question within each domain. The possible total ranges from 0 to 27; greater scores indicate greater symptoms of depression.

A symptom questionnaire can provide a structured way to assess patients’ reported experiences, using the same scoring approach across participants. For a change endpoint, interpretation ordinarily depends on having a defined score at an earlier assessment and a later score for the same participant. Comparing changes between randomized groups can then help distinguish an observed difference from changes that occur in either group over time. These are general features of change-score outcomes, not additional details about this trial’s analysis.

The registry does not post baseline scores or a complete 12-week result for both groups. Although one escitalopram participant has a posted value of 13 QIDS score, the record does not give enough information to treat that number as a baseline-to-follow-up change or to compare changes between groups.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation depends on what outcome is measured, how participants are assigned, what information is available, and how the comparison is analyzed. The registry identifies a randomized parallel-group design, a QIDS primary outcome, and a 12-week time frame. It does not report a detailed statistical analysis plan or any posted analysis results. The explanations below describe general statistical concepts and distinguish them from methods documented for this trial.

What does randomization contribute?

In general, random assignment is intended to make treatment groups comparable at the start of a study, on average, by reducing systematic allocation differences. It does not guarantee that groups will be alike in every characteristic, particularly when enrollment is very small. Here, the record says allocation was randomized and reports enrollment of 4. It does not describe the random sequence, how assignments were concealed, or how the randomization was implemented. Those details are not reported in the registry record.

Why is a between-group estimate needed?

A treatment comparison is ordinarily expressed as an estimate of the difference between groups on a defined outcome, with uncertainty around that estimate. For a change outcome, the data generally need to identify the relevant measurement at the start and the follow-up measurement, or otherwise specify the model used to estimate change. The registry supplies one arm-level entry with 1 participant and a score of 13, but no placebo outcome value. It does not report baseline scores, a calculated change, a difference between groups, or an uncertainty interval. Thus, the record does not support a recalculated two-arm effect.

How should a confidence interval be understood?

In general, a confidence interval reflects uncertainty in an estimate under the assumptions of the analysis method. A narrow interval indicates greater precision than a wide interval, while an interval spanning many plausible effect values signals substantial uncertainty. The interval is not a guarantee that the true effect lies within its limits. No confidence interval for the primary comparison is reported in the registry record, so precision cannot be judged from an interval.

What does a p-value answer?

In general, a p-value measures how unusual the observed data, or more extreme data, would be under a specified null hypothesis and model. It does not measure the probability that a treatment works, the size of an effect, or whether an effect matters clinically. Interpretation requires the estimate, its uncertainty, the analysis assumptions, and the prespecified testing approach. No primary-outcome p-value or test result is posted, and the registry does not describe the planned hypothesis test.

Why do missing observations matter?

Missing outcome data reduce the information available and can affect interpretation. The consequences depend on why measurements are missing and on the relationship between missingness and outcomes. General statistical approaches may rely on assumptions about those relationships, and conclusions can change if the assumptions are not plausible. The registry reports that 1 participant in Arm 1 and 2 participants in Arm 2 were not evaluable at 12 weeks and did not complete the study. It does not report reasons for those missing observations or a method for handling them.

What does over-dispersion mean?

For count outcomes, over-dispersion means that observed variability exceeds what a chosen count model assumes. If it is ignored, standard errors and tests can be misleading. This is a general concept; the registry does not report an over-dispersion assessment or a count-model analysis for the primary endpoint. The posted outcome is described in QIDS score units, with a score definition and range, but no fitted model or dispersion estimate.

How should planning illustrations be read?

Sample-size planning asks how many participants may be needed to detect a chosen effect under specified assumptions. It is distinct from analyzing the enrolled participants, and a planning calculation is not observed power. The record describes planning illustrations based on a stated fraction of the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also states that time-to-event illustrations use total events, while other illustrations use participants per arm. These assumptions describe planning illustrations, not the trial’s documented design justification. The registry does not report its own sample-size justification. Because the primary data do not provide an evaluable two-arm effect, the record cannot support a reliable interpretation of a planning calculation as evidence about the trial’s observed treatment effect.

10. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study evaluates multiple outcomes, time points, treatment contrasts, or statistical tests. In general, conducting many tests can increase the chance of at least one apparently unusual result under a null model. Prespecified testing strategies can address that issue, but the registry record does not report a multiplicity adjustment, a testing hierarchy, or a detailed plan for choosing primary and secondary analyses. The listed primary outcome is change in the rate of depression; the record also lists a secondary quality-of-life outcome using the FACT-Hep survey.

The registry reports 2 outcome measures and 0 posted analyses. The details needed to determine which measures were analyzed, how they were scored, and whether all planned outcomes were reported are not reported in the registry record. No conclusion about selective reporting or adjustment for multiple testing can be drawn from the available information.

Missingness is a central limitation for the primary endpoint. The record states that 1 participant in Arm 1 and 2 participants in Arm 2 were not evaluable at 12 weeks and did not complete the study. It does not report why they were not evaluable, whether missingness occurred before or after treatment exposure, or how missing values were handled. No analysis population definitions—such as an intention-to-treat or per-protocol population—are reported in the registry record.

In general, an intention-to-treat analysis retains participants in their assigned groups, while other analysis populations may apply additional eligibility or follow-up criteria. Those labels alone do not solve missing outcome problems; the treatment of unavailable measurements still needs to be specified. Since the registry provides no primary analysis and no missing-data method, the effects of missingness on the intended comparison cannot be assessed.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: diarrhea (50.0%), nausea (50.0%), acidosis (50.0%), vomiting (50.0%), thromboembolic event (50.0%).

The registry reports serious adverse event figures separately for the escitalopram and placebo groups. In each group, 2 participants are listed as at risk for serious adverse events and 1 as affected. For other adverse events, 2 participants are listed at risk and 2 affected in each group. Deaths are reported as 0 in both groups.

These are counts in a very small trial record. They should not be treated as a stable estimate of how often an event occurs in a broader population, and the counts alone do not establish whether an event was caused by a study treatment. The registry lists diarrhea, nausea, acidosis, vomiting, thromboembolic event, and disease progression among the top serious event terms, each with 50.0%. The posted information does not provide enough detail to establish the relationship of each term to a particular participant, timing, or treatment attribution.

Serious adverse event counts and other adverse event counts are distinct reporting categories. They should not be added together or interpreted as unique people across categories without participant-level information. The safety figures also do not resolve the missing primary outcome data or provide a between-group efficacy analysis.

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

The record documents a randomized comparison of escitalopram and placebo in a Phase II trial for participants with localized pancreatic or periampullary cancer receiving neoadjuvant therapy. It also documents a QIDS-based primary outcome planned for assessment 12 weeks from the start of treatment, a total enrollment of 4, and a terminated status. The available primary outcome entry is limited to 1 participant in the escitalopram arm with a value of 13; the placebo arm has no evaluable value recorded.

Those details do not establish the size or direction of a treatment effect. A single participant’s score cannot characterize the group, and the record does not post the measurements needed to estimate a change or a comparison between randomized groups. No confidence interval or primary-outcome test is reported. The available information therefore cannot show whether symptoms changed, whether any change differed between groups, or how precise such a difference might be.

The record also does not show that escitalopram is effective or ineffective for depression symptoms in this cancer-treatment setting. Lack of a reported comparison is not evidence that the groups had the same outcomes. Likewise, the trial’s termination does not explain why it ended; a reason is not reported in the registry record. The safety figures describe reported event counts but do not determine treatment causality or substitute for the missing outcome analysis.

In general, results from randomized trials are interpreted by considering the estimated effect, its uncertainty, the study conduct, and the completeness of the data. Here, the sparse primary outcome data and absence of posted analyses prevent that fuller assessment. Any broader clinical or biological conclusion would go beyond what this registry record establishes.

13. Why This Trial Matters Statistically

This trial illustrates an important statistical distinction: a randomized design can define a useful comparison, but the design alone does not produce an interpretable treatment-effect estimate. The registry identifies escitalopram and placebo groups and a patient-reported depression measure. Yet the posted primary outcome has a result for only 1 participant in one group and no value in the other. Without an evaluable contrast, the central statistical question remains unanswered by the posted results.

The record also shows why enrollment and outcome completeness are different concepts. Enrollment is 4, but the primary endpoint information is not complete for both groups at the stated 12-week assessment. A trial’s planned assessment and recorded result can therefore differ substantially in how much information they offer for inference. The record does not provide the reasons for missing assessments, which limits evaluation of whether the observed data could represent the intended study population.

Another important issue is the boundary between planning and evidence. Sample-size planning is based on assumptions about effects, variability, and design. It does not establish what happened in the trial, and it is not a substitute for an observed estimate with uncertainty. The registry does not report the trial’s own sample-size justification or a complete analysis plan.

Finally, the record contains a difference between the official title’s double-blind description and the structured single-masking entry. That discrepancy illustrates why trial design details should be interpreted with attention to how the registry records them; the information available does not identify who was masked. Together, these features make the trial statistically informative as an example of the limits imposed by sparse and incomplete outcome reporting, rather than as a basis for a precise treatment comparison.

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 primary limitation is the lack of an evaluable result in both groups. The escitalopram arm has a single participant with a recorded QIDS value, while the placebo arm has no value. The registry further states that 1 participant in Arm 1 and 2 participants in Arm 2 were not evaluable at 12 weeks and did not complete the study. There is no posted group comparison, uncertainty interval, or hypothesis test.

The score of 13 cannot be interpreted as a change from baseline because the record does not provide baseline measurements or explain how the posted value relates to the change endpoint. Reasons for non-evaluation and non-completion are not reported in the registry record. Nor does the record specify missing-data methods or analysis-population definitions.

Enrollment was 4, which sharply limits the amount of information available even apart from missing outcomes. Randomization cannot ensure balanced groups in a very small study. The registry does not report baseline characteristics, treatment adherence, participant-level data, or details of the neoadjuvant regimens, so these aspects cannot be assessed.

Other design and analysis details are also limited: the official title calls the trial double-blind, while the structured masking entry says single; who was masked is not reported. The randomization procedure, sample-size justification, interim analyses, and statistical analysis plan are not reported in the registry record. The reason for termination is also not reported. These limitations preclude a detailed assessment of conduct, analysis choices, and the reasons for the sparse result.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Escitalopram to Placebo in Patients With Localized Pancreatic Cancer — NCT05289830.
• Registry record last updated 2025-12-10; status last verified 2025-10.
• Results first posted 2025-12-10.
• 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.

18. Record Summary

NCT05289830 is a randomized, parallel-group Phase II trial comparing escitalopram with placebo in participants with localized pancreatic or periampullary cancer receiving neoadjuvant therapy. Enrollment was 4. The registry lists a start date of 2022-08-05, primary completion on 2023-08-27, and status as terminated.

The primary outcome was change in depression symptoms measured with the QIDS score at 12 weeks from treatment start. The posted outcome includes 1 escitalopram participant with a value of 13 and no placebo value. The record says that 1 participant in Arm 1 and 2 participants in Arm 2 were not evaluable at 12 weeks and did not complete the study. No statistical analyses are posted, and the registry record does not provide an evaluable two-arm primary-outcome comparison.

Serious adverse events affected 1 participant in each group, with 2 participants at risk in each group; deaths were 0 in both groups. The reason for termination and a detailed statistical analysis plan are not reported in the registry record.