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 Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome (NCT01035073), a na phase 4 study. The primary outcome is 24-hour Activity Level.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01035073 |
| Phase | Phase 4 |
| Condition | Major Depressive Disorder, Soft Tissue Discomfort Syndrome, Pain |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 22 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Pennsylvania |
| Results posted | Yes |
2. Clinical Question
Population
Patients with major depressive disorder and co-morbid soft tissue discomfort symptoms. The registry lists major depressive disorder, soft tissue discomfort syndrome and pain among the conditions studied.
Intervention
Duloxetine, the study’s listed drug intervention.
Comparator
No comparator group is listed. The study is described as single-group, with allocation marked NA and masking marked none.
Primary question
How did 24-hour activity level change from baseline to Week One of treatment? The study description also states hypotheses about the time course of symptoms and functional change, but the registry does not provide outcome data with which to assess them.
The study’s stated objective was to examine the time course of duloxetine efficacy on symptoms of major depressive disorder and soft tissue discomfort syndrome, using 24-hour Actigraph measures. The description hypothesizes reductions in both sets of symptoms and proposes that functional ratings and activity might improve rapidly, potentially before an antidepressant effect is observed. Those statements describe research hypotheses, not findings.
The registered primary outcome is 24-hour Activity Level, with measurements planned at baseline and Week One of treatment. A Functional Symptom Questionnaire is listed as a secondary outcome. The registry record does not report the activity values, questionnaire results, or an analysis comparing measurements over time. It therefore does not establish whether the proposed changes occurred or when they might have occurred.
3. Trial Design
This was a completed Phase 4, single-group study of duloxetine, sponsored by the University of Pennsylvania. The registry reports enrollment of 22. Allocation is listed as NA, and masking is listed as none. No comparator group is described, so the design is not a randomized, controlled comparison.
The study record gives a start date of 2006-04 and a primary completion date of 2009-05. It identifies major depressive disorder, soft tissue discomfort syndrome and pain as conditions of interest. The intervention is duloxetine; no further arm description is posted in the registry record.
The primary outcome was 24-hour Activity Level at baseline and Week One of treatment. A Functional Symptom Questionnaire is listed as a secondary outcome, and the record indicates 2 outcome measures. Although the study description discusses symptoms of depression and soft tissue discomfort as objectives, the primary outcome entry itself specifies activity level.
The registry says that the investigator’s serious health issues prevented data entry, that the study team was no longer at the university, and that efforts to contact the team did not lead to data being entered. The primary outcome data are therefore unavailable in the registry record. The record lists 0 analyses. It does not report an analysis plan, statistical methods used for the outcomes, an analysis population, or a sample-size justification. The completed status indicates the study’s registered status; it does not supply the missing efficacy results.
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: The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.
Overall Study
| Stage | Duloxetine |
|---|---|
| STARTED | 0 |
| COMPLETED | 0 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.
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: The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.
| Characteristic | Unit | Duloxetine |
|---|---|---|
| Participants analysed | 0 | |
| Age, Customized: All Participants | participants | — |
| Sex/Gender, Customized: All Participants | participants | — |
| Region of Enrollment: United States | participants | — |
6. Primary Endpoint
The registry lists the primary outcome as 24-hour Activity Level, measured over Baseline and Week One of Treatment.
| 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 endpoint is 24-hour Activity Level, assessed at baseline and Week One of treatment. The study description identifies 24-hour Actigraph measures as a way to examine activity over time. In general, activity monitoring can provide a functional measure that is distinct from a symptom questionnaire: it records activity rather than asking participants to rate symptoms. The registry does not describe the specific device-processing method, the scale or units of the endpoint, or how activity measurements were summarized.
A baseline and follow-up assessment can be used to characterize change over time within a group. In general, such a comparison describes change during the observation period; without a comparator group, it cannot by itself separate a treatment-associated change from other influences that also vary over time. The listed timeframe is baseline and Week One, so the registered primary endpoint concerns that interval rather than a longer-term activity trajectory.
The registry record gives no activity measurements or estimated change. It also does not report the number of participants with usable measurements at either assessment, the method used to handle missing measurements, or an uncertainty estimate. Consequently, the endpoint’s observed value and the precision of any estimated change cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
No primary outcome result is available in the registry record. Although 24-hour Activity Level is identified as the primary endpoint and baseline and Week One are specified as its assessment times, the record states that the data are not available. There is no reported estimate of activity, change from baseline, confidence interval, or statistical test to interpret.
The study description sets out hypotheses about duloxetine, depression symptoms, soft tissue discomfort symptoms, functional ratings and activity. These are hypotheses rather than reported results. The registry does not provide data that would show whether any of these measures changed, how large a change might have been, or whether a change occurred before another outcome changed. The Functional Symptom Questionnaire is listed as a secondary outcome, but its results are also not reported in the registry record.
For general interpretation, an estimate describes the direction and magnitude of an observed effect, while a confidence interval conveys uncertainty around that estimate. Neither can be discussed for this study’s primary endpoint because no numerical outcome results are reported. A p-value, if available, would address compatibility with a specified statistical null under the assumptions of a test; it would not by itself indicate the size or importance of a change. No p-value or other inferential result is reported.
The single-group design also limits what a within-group change could establish, even if measurements were available. Without a comparator, change over time cannot uniquely be attributed to duloxetine rather than to other influences. This is a design consideration, not a claim about what happened to participants. The record does not report whether any particular change occurred.
The registry’s adverse-event fields list zero participants at risk and zero affected for the listed categories. With no participants recorded as at risk in those fields, these entries do not establish that no adverse events occurred. The registry record does not provide usable outcome data or an efficacy analysis, so no treatment effect or safety conclusion can be drawn from the posted results.
9. Statistical Methods Explained
The registry describes a single-group study with allocation marked NA and masking marked none. That description matters when interpreting evidence: there is no registered comparison group against which to assess what would have happened over the same period without the intervention. The record does not report random assignment, a control condition, or blinding. These design features should not be inferred from the Phase 4 designation or the completed status.
What does a within-group change estimate?
In general, a within-group analysis compares measurements from participants at different times. When the same participants are measured repeatedly, the analysis may account for the fact that observations from one participant are related. The registry identifies baseline and Week One as the primary endpoint time points, but it does not report the statistical method used to compare them, whether observations were paired in the analysis, or how incomplete pairs were handled.
A change estimate would describe the observed difference between the scheduled assessments under the chosen definition of the endpoint. Its interpretation depends on the scale, summary measure and analysis population. Those details are not reported in the registry record, and the underlying activity values are unavailable. No change estimate can therefore be interpreted or recalculated from the posted results.
What does a confidence interval communicate?
In general, a confidence interval gives a range of values compatible with an estimate under a statistical model and its assumptions. Its width conveys precision: a narrower interval indicates less statistical uncertainty under that model, while a wider interval indicates more. An interval is not a guarantee that the true effect lies within its endpoints, and it does not resolve bias from a weak comparison design or missing data. The registry record reports no interval for 24-hour Activity Level or the Functional Symptom Questionnaire.
How should a p-value be read?
In general, a p-value describes how unusual data at least as extreme as those observed would be under a specified null hypothesis and model. It is not the probability that the null hypothesis is true, nor does it measure the size or practical importance of an effect. A p-value is interpretable only alongside the analysis, endpoint definition and assumptions. No p-value or statistical test result is reported in the registry record, so there is no significance finding to characterize.
Why does the endpoint scale matter?
Statistical methods should match the outcome’s measurement scale and data pattern. A method for continuous measurements differs from one for counts or categories, and repeated measurements require attention to within-participant dependence. This is general methodological guidance; the registry does not specify the activity endpoint’s units, distribution, summary method or model. It would not be justified to assign a particular model to the study.
Over-dispersion is a general concern when count data vary more than an assumed model allows. If relevant, failing to account for it can make uncertainty estimates too small. The registry does not identify the primary activity measure as a count outcome or report a count-data model, so over-dispersion cannot be identified as a study-specific issue from this record.
What do planning calculations mean?
Sample-size calculations are planning tools: they describe the amount of information a future study might need under stated assumptions. They do not represent the results of the completed study, and they are not observed power. A planning calculation based on an effect estimate also depends on that estimate and on choices such as the target effect and analysis assumptions. The registry record does not report the trial’s own sample-size justification or statistical plan. No planning illustration can substitute for the missing outcome data or establish what the study observed.
The record lists 0 analyses. This means no analysis is listed in the registry entry; it should not be expanded into an account of methods that the record does not describe. There is no sponsor analysis to compare with a recalculation, and no posted summary statistics from which an unadjusted result could be recalculated. Accordingly, no recalculated result or claim about agreement with a sponsor analysis is appropriate.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 24-hour Activity Level as the primary outcome and Functional Symptom Questionnaire as a secondary outcome, with 2 outcome measures indicated. It does not report a multiplicity plan, such as how inference across outcomes or repeated assessment times was handled. In general, testing multiple outcomes can increase the chance of at least one apparently notable result under a collection of null hypotheses. Methods that address multiplicity need to be specified and interpreted in context; no such method is reported in the registry record.
The primary outcome data are explicitly unavailable in the registry record. The record attributes this to the investigator’s serious health issues preventing data entry and the study team no longer being at the university, despite efforts to contact the team. Results for the secondary outcome are also not reported. The record does not state how many participants had missing measurements, why any individual measurement might be missing, or how missingness was handled analytically.
The registry reports enrollment of 22, but does not report the analysis population or the number with outcome data at each time point. Enrollment should not be treated as the number analyzed for an endpoint. The record also does not describe whether analyses were based on all enrolled participants, participants who began treatment, or participants with complete outcome measurements.
In general, missing outcomes can affect both the amount of information available and the validity of an estimate, depending on why data are missing and how the analysis handles them. With no reported outcome data or missing-data analysis, the direction and extent of any such effect cannot be assessed. The registry’s absence of results is not itself evidence of a particular participant-level missingness mechanism.
11. What the Result Does, and Does Not, Mean
The record establishes that a completed Phase 4, single-group study of duloxetine was registered, with enrollment of 22 and a planned primary assessment of 24-hour Activity Level at baseline and Week One. It also records a secondary Functional Symptom Questionnaire and the study’s hypotheses about depression symptoms, soft tissue discomfort symptoms and functional change.
It does not establish that activity or symptoms improved, worsened or remained unchanged. The primary outcome data are not available in the registry record, and the secondary outcome results are not reported. No estimate, uncertainty interval, statistical test or analysis population is available for interpreting either outcome. The stated hypotheses should not be mistaken for observed findings.
Even if a within-group change estimate had been reported, a single-group design would not by itself distinguish change associated with treatment from change due to other influences over time. This general limitation does not indicate that an alternative explanation did or did not occur in this study; it describes what the design can support.
The adverse-event fields list zeros alongside zero participants at risk. Those entries do not show that no adverse events occurred, because the record does not report a group at risk in those fields. More broadly, the missing efficacy data and lack of reported analyses mean the registry cannot support a conclusion about the magnitude, precision or statistical significance of an outcome. These limitations concern what can be concluded from the record, not a claim about the underlying experience of participants.
12. Why This Trial Matters Statistically
This study illustrates why a registered objective and a completed status are not substitutes for posted results. The record specifies a clinically motivated question about activity and symptoms over time, and it identifies an objective primary outcome and assessment timeframe. But without the outcome values and analysis, readers cannot assess the observed change or its uncertainty.
It also shows how design and data availability jointly shape interpretation. A single-group study can describe change within the group, but it does not provide a concurrent control comparison. In this record, even that within-group description cannot be made because the primary data are unavailable. Distinguishing a design limitation from a missing-results limitation is important: one concerns what a comparison can establish, and the other concerns the absence of reported estimates.
The registry’s explanation for unavailable data highlights a practical aspect of evidence reporting: data entry and continued access to study teams matter for making results interpretable. The entry records efforts to obtain the data but does not provide an analysis or explain how unreported outcomes were handled.
For statistical readers, the case reinforces the need to separate hypotheses, planned measures and findings. The study description presents proposed effects; the outcomes identify what was intended to be measured; neither supplies evidence that an effect was observed. Reporting estimates, uncertainty, analysis populations and missing-data handling would be necessary for readers to evaluate the results, but those details are not reported in the registry record.
13. 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 principal limitation for interpreting this trial is that the primary outcome data are unavailable in the registry record. The registry explains that the investigator’s serious health issues prevented data entry and that the study team was no longer at the university; efforts to contact the team did not result in data being entered. No activity values, change estimate or uncertainty measure is reported.
The design is single-group, with allocation marked NA and masking marked none. No comparator is listed. Thus, even if within-group outcome data were available, a change over time could not by itself isolate an effect attributable to duloxetine from other influences. This is a limitation of the design, not evidence about the direction of any actual change.
The record does not report the analysis population, endpoint units, statistical methods, missing-data handling, multiplicity approach or the study’s sample-size justification. The Functional Symptom Questionnaire is listed as a secondary outcome, but its results are not reported. The registry lists 0 analyses, so there is no reported inferential analysis to assess.
Adverse-event fields show zero participants at risk and zero affected in the listed categories. Because the record does not indicate participants at risk in those fields, these entries cannot establish an absence of adverse events. Taken together, the limitations prevent evaluation of efficacy estimates, their precision and the completeness of outcome reporting from the registry entry.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome — NCT01035073.
- Registry record last updated 2020-04-16; status last verified 2020-04.
- Results first posted 2020-04-16.
- 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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17. Record Summary
NCT01035073 is a completed Phase 4, single-group study sponsored by the University of Pennsylvania. The intervention was duloxetine, and the registry reports enrollment of 22. The study began in 2006-04 and had a primary completion date of 2009-05.
The primary outcome was 24-hour Activity Level at baseline and Week One of treatment. The Functional Symptom Questionnaire is listed as a secondary outcome. The study description states hypotheses concerning depression symptoms, soft tissue discomfort symptoms, functional ratings and activity.
The primary outcome data are unavailable in the registry record, and secondary outcome results and analyses are not reported. Allocation is listed as NA and masking as none; no comparator group is listed. The record does not report a statistical plan, analysis population or missing-data method. Its adverse-event fields list zero at risk and zero affected, which does not establish that no adverse events occurred.