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 Sinusitis and Facial Pain Disorders Anti-Depression Trial (NCT00754793), a randomized phase 4 study. The primary outcome is Sino-Nasal Outcome Test-20 (SNOT-20).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00754793 |
| Phase | Phase 4 |
| Condition | Chronic Sinusitis, Facial Pain Disorder, Depression |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | Double |
| Enrollment | 3 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Washington |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with depression together with chronic sinusitis or a facial pain disorder. The registry record does not report further eligibility details, such as how these conditions were defined, how depression was assessed, or what age range was eligible. Enrollment is listed as 3.
Intervention
The intervention is escitalopram, described in one arm as 10mg - 30mg daily. The study summary says the drug was intended as an addition to a standard treatment regimen. The details of that regimen and how the escitalopram dose was selected or adjusted are not reported in the registry record.
Comparator
The comparator is placebo. The summary describes a double-blind, placebo-controlled study, and the arm descriptions list escitalopram and placebo. The placebo arm’s additional treatment details and the procedures used to maintain masking are not reported in the registry record.
Primary question
The stated hypothesis asks whether adding an antidepressant to the standard regimen is associated with lower reported chronic sinusitis or facial pain symptom severity among people who also have depression. The named primary outcome is the Sino-Nasal Outcome Test-20 (SNOT-20), assessed at baseline, 1 month, and 3 months. No outcome values or comparison between groups are reported in the registry record, so the hypothesis cannot be evaluated from its posted results.
3. Trial Design
The registry identifies this as a phase 4 study sponsored by the University of Washington. Its status is terminated, and enrollment is listed as 3. The registry gives a start date of 2009-01 and a primary completion date of 2010-08. Those dates describe the record, but do not explain why the study was terminated or whether the planned follow-up was completed.
The allocation is recorded as randomized and masking as double. The study summary further describes a stratified, randomized, double-blind, placebo-controlled study. It presents escitalopram as treatment for depression in people with depression and chronic sinusitis or depression and facial pain disorders. The summary describes a 12-week study with a screening visit, weekly phone follow-up for four weeks, and bi-weekly follow-up for 8 weeks.
There is an inconsistency in the design metadata: the registry labels the model SINGLE GROUP, while the allocation, intervention list, arm descriptions, and summary describe randomized comparison of escitalopram and placebo. The record does not resolve this discrepancy, so the single-group label should not be treated as a sufficient description of the study’s intended comparison.
The escitalopram arm is described as receiving 10mg - 30mg daily. The second arm is labeled placebo, but its description is blank. The registry does not report the randomization procedure, allocation concealment, stratification factors, masking procedures, or reasons for termination. These omissions prevent a fuller assessment of how the intended design was carried out.
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.
Before assignment: No adverse events. No exclusions post enrollment.
Overall Study
| Stage | Active Drug (Lexapro) | Placebo |
|---|---|---|
| STARTED | 1 | 2 |
| COMPLETED | 1 | 1 |
| NOT COMPLETED | 0 | 1 |
Reasons for not completing this period:
| Reason | Active Drug (Lexapro) | Placebo |
|---|---|---|
| voluntary withdrawn from study | 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 | Active Drug (Lexapro) | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 1 | 2 | 3 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | 1 | 2 |
| Age, Categorical: >=65 years | Participants | 0 | 1 | 1 |
| Age, Continuous | years | 45 (SD 45) | 50 (SD 50) | 48 (SD 48) |
| Sex: Female, Male: Female | Participants | 1 | 1 | 2 |
| Sex: Female, Male: Male | Participants | 0 | 1 | 1 |
| Region of Enrollment: United States | participants | 1 | 2 | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Sino-Nasal Outcome Test-20 (SNOT-20), measured over baseline, 1 month, 3 months.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is named as the Sino-Nasal Outcome Test-20 (SNOT-20), with assessments scheduled at baseline, 1 month, and 3 months. The registry record does not describe the instrument’s scoring, the meaning of a higher or lower score, the method of administration, or the specific outcome contrast intended for analysis. It also does not give results at any of the listed time points.
In general, a patient-reported outcome can capture a participant’s experience of symptoms and their effects in a way that may not be represented fully by clinical observations alone. An outcome focused on sinonasal concerns is relevant to the study’s stated question about chronic sinusitis symptom severity. The study also includes people with facial pain disorders, but the registry does not clarify how the SNOT-20 relates to those participants’ symptoms or whether separate outcome definitions were planned for the two clinical groups.
Repeated assessment can describe change over time, but a treatment comparison requires a defined analysis: for example, a comparison at a chosen follow-up or a comparison of change from baseline. The registry lists multiple assessment times and does not identify one reduced comparison. No numerical endpoint results or analysis are reported in the registry record. Consequently, the outcome name and schedule alone do not establish the direction, size, or precision of any treatment-group difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available record supports a description of the study’s intended question and design, not an estimate of treatment effect. The primary endpoint is identified as SNOT-20, and the record lists baseline, 1 month, and 3 months as assessment times. It does not report endpoint scores, changes from baseline, a contrast between randomized groups, confidence intervals, or a statistical test for that outcome. The posted results therefore do not establish whether the groups differed, how large any difference might have been, or how precisely it could be estimated.
The record lists 3 participants enrolled and marks the study terminated. That enrollment is important context for interpreting what is available, but it does not by itself describe how many participants were assigned to each arm, whether all enrolled participants began treatment, or how many contributed primary-outcome data. Those details are not reported in the registry record. No conclusion about completion or follow-up can be drawn from the dates alone.
The design description contains a conflict: randomization and two intervention arms are recorded, while the model is labeled SINGLE GROUP. The study summary says the design was stratified, randomized, double-blind, and placebo-controlled. The registry does not explain the model label, so the underlying design cannot be reconstructed with confidence from that entry alone. The discrepancy should be kept visible rather than resolved by assumption.
There are no posted analyses, according to the registry record. In particular, no adjusted or unadjusted endpoint comparison is reported. This means there is no inferential result to interpret and no basis for describing statistical significance or nonsignificance. The absence of an analysis is not evidence that groups had the same outcomes; it means the record does not provide an estimate with which to assess a difference.
Any sample-size planning illustration is distinct from the observed trial record. The stated planning framework uses a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such calculations are hypothetical planning aids, not observed power and not a replacement for missing trial results. The record does not report a trial-specific sample-size justification. No numerical treatment effect or sample-size illustration should be interpreted as an outcome of this terminated study.
9. Statistical Methods Explained
There are no analysis records reported in the registry. That limits statistical interpretation to the design information and endpoint schedule. The study’s brief summary describes a randomized, double-blind, placebo-controlled comparison, but the model field is recorded as SINGLE GROUP. The record does not reconcile those descriptions. Statistical methods should therefore not be inferred from the design label alone.
What randomization is intended to do
General: Random allocation is used to make treatment assignment less dependent on participants’ characteristics or clinicians’ choices. If implemented as planned, it can support a fair comparison between groups by balancing known and unknown prognostic factors on average. It does not guarantee that the groups will look alike in a small study, and it does not compensate for missing outcome data, deviations from assigned treatment, or incomplete reporting. The registry describes stratified randomization, but the factors used for stratification, sequence-generation method, allocation concealment, and implementation details are not reported in the registry record.
What masking can and cannot establish
General: Double masking aims to limit the influence of treatment knowledge on participants’ reports and on study assessments or care. Masking is a design feature, not a statistical result. The registry marks masking as double and calls the study double-blind, but does not state which roles were masked or how masking was maintained. The record also does not report whether masking was assessed after treatment began.
What an endpoint comparison would require
General: A group comparison needs a clearly specified outcome, time point or time-course estimand, analysis population, and method for handling baseline values and missing observations. The SNOT-20 is named as the primary outcome, and its timing is listed as baseline, 1 month, and 3 months. But the registry does not specify whether the intended comparison concerned the follow-up score, change from baseline, or a pattern across multiple visits. It does not describe a model, covariate adjustment, or decision rule for drawing an inferential conclusion.
A confidence interval, when reported, expresses uncertainty around an estimated effect under the assumptions of the analysis. It would help readers judge which effect sizes remain compatible with the data, rather than relying only on a significance test. No estimate or confidence interval for the primary outcome is reported in the registry record. A p-value is also not reported; therefore, neither statistical significance nor a lack of statistical significance can be inferred.
Why repeated measurements and multiple questions matter
General: Repeated measurements can be analyzed in different ways, and choosing among visits or outcome contrasts can affect interpretation. Testing multiple outcomes or time points also creates multiplicity: with more opportunities to identify an apparently unusual result, the chance of a false-positive finding can increase unless the analysis plan addresses that issue. The record names one primary outcome but lists multiple assessment times. It does not report a multiplicity strategy, a hierarchy among time points, or a prespecified primary contrast.
How to read planning calculations
The registry’s planning assumptions describe an illustration based on the observed effect, not the study’s own design justification. The listed assumptions are a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; the effect to detect is expressed as the stated fraction of the observed effect. The record does not report a sample-size justification for the trial. A planning estimate under assumptions is not observed power and cannot establish what the completed study could reliably detect. Without a reported effect estimate and analysis, such planning quantities should not be read as evidence about efficacy.
General: Power calculations depend on assumptions about the target effect, variability, error rate, allocation, and analysis. If the assumed effect is larger than the effect of interest, a planning exercise can understate the sample size needed for a more modest effect. An illustration based on an observed effect can also be unstable when that effect is estimated imprecisely. These are general considerations; the record does not report enough outcome information to assess them for this study.
What the analysis record leaves unresolved
The registry reports no analyses. It does not provide treatment-group endpoint summaries, participant flow, analysis populations, missing-data methods, protocol deviations, or details of any interim analysis. None of these methods should be filled in by assumption. For this record, the appropriate statistical conclusion is that the intended comparison is described but the result is not reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies SNOT-20 as the primary outcome and lists baseline, 1 month, and 3 months as assessment times. It does not specify which follow-up contrast was primary, whether the repeated measurements were to be analyzed jointly, or whether additional outcomes were prespecified. The record does not report a method for controlling multiplicity or a hierarchy for interpreting results across time points. Because no endpoint analysis is reported, there is no multiplicity-adjusted or unadjusted result to interpret.
Missing-data methods and analysis populations are also not reported in the registry record. The record does not state how many participants completed each visit, whether all randomized participants were included in an analysis, how missing SNOT-20 values were handled, or whether any sensitivity analyses were planned. Enrollment is listed as 3, but this does not establish the number with usable outcome data or the distribution of participants across the named arms.
General: Missing outcome data can affect an estimate when the likelihood of missingness is related to participants’ health, treatment, or observed outcomes. Analytic choices such as excluding incomplete cases, using a model that accommodates incomplete repeated measures, or applying an imputation approach rely on different assumptions. Without the missingness pattern and analysis plan, readers cannot assess whether those assumptions are plausible. These are general statistical concerns, not claims about what occurred in this study.
The registry status is terminated, but the reason for termination and the extent of data collection are not reported in the registry record. That status does not reveal whether the scheduled assessments were completed or why no outcome analysis appears. It is not possible to distinguish among incomplete follow-up, non-submission of results, or other explanations based on the posted 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 |
|---|---|---|---|
| Active Drug (Lexapro) | 0 | 1 | 0.0% |
| Placebo | 0 | 2 | 0.0% |
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 |
|---|---|
| Active Drug (Lexapro) | 0 of 1 |
| Placebo | 0 of 2 |
The adverse-event record lists an Active Drug (Lexapro) group and a Placebo group. For serious adverse events, the active-drug group has 1 at risk and 0 affected; the placebo group has 2 at risk and 0 affected. The other-adverse-event figures also list 1 at risk and 0 affected for Active Drug (Lexapro), and 2 at risk and 0 affected for Placebo. These are the registry’s posted counts and should be read in the context of the limited enrollment recorded for the study.
The figures do not provide event descriptions, timing, severity grading beyond the serious-versus-other categories, or information about how events were collected. The record lists no terms among the top serious adverse events. Deaths are recorded as null for both groups; this is not the same as a reported count of zero, so deaths are not reported in the registry record.
General: A count of zero affected participants in a small record does not establish that an event is impossible or that a treatment is free from risk. It describes only the events captured and submitted for the participants represented in that group. Without fuller follow-up, event definitions, and exposure information, the counts cannot characterize uncommon harms or support a broad safety comparison. The registry record does not provide enough information to assess the completeness of adverse-event ascertainment.
12. What the Result Does, and Does Not, Mean
The record documents a terminated phase 4 study sponsored by the University of Washington, with enrollment listed as 3. Its stated question concerns adding escitalopram to a standard treatment regimen for people with depression and chronic sinusitis or facial pain disorders. It identifies placebo as the comparator and SNOT-20 as the primary outcome, with assessments scheduled at baseline, 1 month, and 3 months. These details establish what the study was intended to examine, but not what its results were.
No primary-outcome values, between-group estimates, confidence intervals, p-values, or analyses are reported in the registry record. As a result, the posted information does not quantify an effect or its precision. It cannot establish whether scores changed, whether the groups differed, or whether any observed difference would be compatible with chance variation. The absence of a reported analysis should not be interpreted as evidence of equal outcomes or as evidence that the treatment was ineffective.
The design metadata also requires caution. The record describes randomization and two treatment arms, and its summary calls the study stratified, randomized, double-blind, and placebo-controlled. Yet the model is labeled SINGLE GROUP. The record does not resolve that inconsistency. Nor does it report the reason for termination, arm-specific outcome availability, or the statistical plan.
The adverse-event entries show 0 affected participants for serious and other events in each listed group, with at-risk counts of 1 for Active Drug (Lexapro) and 2 for Placebo. Those counts do not establish the absence of risk. The deaths fields are null, not reported zero counts.
The most defensible reading is narrow: the registry records the intended comparison, a small listed enrollment, a terminated status, and limited adverse-event entries, but no efficacy analysis. Any planning illustration is a hypothetical calculation under stated assumptions, not a trial result or observed power. Conclusions beyond that are not supported by the registry record.
13. Why This Trial Matters Statistically
This record is statistically instructive because it separates a planned clinical question from an analyzable result. A randomized, double-blind, placebo-controlled design is described, and a primary outcome and assessment schedule are named. Yet the registry provides no outcome analysis. A well-defined question and a recognized design do not by themselves produce an interpretable estimate; the results, their uncertainty, and the analysis methods must also be reported.
The enrollment listing of 3 places the record’s scale in view, while leaving essential details unknown. The record does not give arm-specific enrollment for the primary outcome, participant flow, or the number with follow-up measurements. Small studies can yield imprecise estimates, but precision cannot be evaluated in this case because no effect estimate or confidence interval is reported. It would be inappropriate to infer a numerical effect or to calculate one from the available information.
The conflict between a SINGLE GROUP model label and descriptions of randomization with escitalopram and placebo illustrates why registry fields need to be read together. Inconsistencies should remain explicit unless the record resolves them. The listing of multiple assessment times also underscores the value of specifying a primary time point or contrast and a plan for multiplicity before results are examined.
The posted adverse-event counts illustrate another point: zero recorded events in a limited registry entry is not a comprehensive safety estimate. Counts need denominators, exposure context, event definitions, and information about completeness to support a broader interpretation. Here, the at-risk counts are recorded, but key contextual details and death counts are not reported.
The statistical lesson is not a claim about the intervention. It is that design labels, endpoint names, and safety counts are not substitutes for transparent reporting of methods and results. The registry record leaves the central treatment comparison unresolved.
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.
Several limitations specific to this record constrain interpretation. First, the study is marked terminated, but the reason for termination is not reported in the registry record. The primary completion date is listed as 2010-08, but that date does not establish that participants completed the planned follow-up or that outcome collection was complete.
Second, the enrollment listing is 3, while the record does not report arm-specific enrollment for efficacy analyses, participant disposition, or completion at each scheduled SNOT-20 assessment. The adverse-event entries list at-risk counts by group, but those entries do not describe the analysis population or verify the completeness of follow-up. The registry does not report whether all randomized participants were analyzed.
Third, the intended design is not fully clear from the metadata. Randomized allocation and two intervention arms are described, but the model is labeled SINGLE GROUP. The record does not explain this inconsistency. The dose range is listed for escitalopram, but dosing procedures, adherence, concomitant treatment details, and placebo-arm details are not reported in the registry record.
Fourth, the SNOT-20 is named, but the score definition, direction, planned comparison, analysis method, and handling of baseline measurements are not reported. Assessment times are listed at baseline, 1 month, and 3 months, without a reported priority among follow-up times. The record also does not report missing-data methods, multiplicity procedures, or an analysis population.
Finally, no outcome results or statistical analyses are reported. The adverse-event record gives limited counts, and the deaths fields are null. These gaps prevent assessment of treatment-effect magnitude, precision, and completeness of safety reporting. They also prevent determining whether the planned study question was answered.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Sinusitis and Facial Pain Disorders Anti-Depression Trial — NCT00754793.
- Registry record last updated 2014-01-17; status last verified 2013-12.
- Results first posted 2012-08-03.
- 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
The registry record identifies a phase 4 study sponsored by the University of Washington, with status terminated and enrollment listed as 3. It describes a randomized, double-blind, placebo-controlled comparison of escitalopram and placebo for people with depression together with chronic sinusitis or a facial pain disorder. The study summary describes a 12-week schedule, and the primary outcome is SNOT-20 at baseline, 1 month, and 3 months.
The record contains conflicting design information: randomized allocation and two arms are described, while the model is labeled SINGLE GROUP. It does not report the reason for termination, a primary-outcome analysis, effect estimates, confidence intervals, p-values, or analysis methods. Adverse-event counts are limited to the posted at-risk and affected figures; deaths are not reported as numeric counts. The central treatment comparison therefore remains unreported in the registry record.