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 Duloxetine for Menopausal Depression (NCT01117857), a na phase 4 study. The primary outcome is Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01117857 |
| Phase | Phase 4 |
| Condition | Depression, Menopause, Vasomotor Symptoms |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 29 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Massachusetts General Hospital |
| Results posted | Yes |
2. Clinical Question
Population
Symptomatic menopausal women with depression and vasomotor symptoms were the intended study population. The primary-outcome description says 19 participants received study medication; 16 were considered evaluable because they returned for at least one assessment after starting the intervention.
Intervention
Participants received duloxetine after a one-week placebo lead-in. The planned regimen was 30 mg per day for one week, followed by 60 mg per day for 7 weeks.
Comparator
There was no concurrent comparison group in the single-group design. The placebo lead-in preceded duloxetine and is not described as a control arm for the treatment period.
Primary question
Did depression scores, measured with the Hamilton Rating Scale for Depression, change from baseline to week 9 during the intervention? Numerical results for that change are not reported in the registry record.
The registry describes a study of duloxetine in symptomatic menopausal women and identifies depression as the primary clinical question. Its brief summary also states a secondary aim: to examine change in vasomotor symptoms, with menopause symptoms assessed using the Greene Climacteric Scale.
The design limits what the study can establish. Because the registry identifies a single group and no allocation, it does not describe a randomized comparison of duloxetine with a concurrent control treatment. Any change during follow-up would therefore describe the course of measured symptoms in the treated group; by itself, it would not distinguish a treatment effect from other explanations for change over time.
The registry lists an enrollment of 29, while the primary-outcome description separately reports that 19 received study medication and 16 were evaluable for analyses. These figures describe different stages or analysis populations as recorded; the record does not explain their relationship in detail. The primary numerical outcome itself is not reported, so the clinical question cannot be answered from a reported effect estimate in this record.
3. Trial Design
NCT01117857 is a completed phase 4 study sponsored by Massachusetts General Hospital. The registry lists a single-group model, allocation as NA, and no masking. The recorded enrollment is 29. The study start is listed as 2009-08 and primary completion as 2011-06.
The intervention was duloxetine. According to the arm description, eligible participants first had a one-week placebo lead-in, then received duloxetine 30 mg per day for one week, with the dosage increased to 60 mg per day for 7 weeks. This sequence is a treatment regimen, not a randomized comparison: the registry does not describe a concurrent control group receiving placebo or another intervention during the treatment period.
The primary outcome was change in depression scores measured by the Hamilton Rating Scale for Depression (HAM-D), with the timeframe specified as baseline to week 9. The outcome is described using a median and inter-quartile range. A secondary outcome is change in menopause symptoms as measured by the Greene Climacteric Scale. The registry lists 5 outcome measures and 0 analyses, but does not provide numerical results for the primary outcome in the registry record recorded for this analysis.
The primary-outcome description states that 19 participants received study medication and that 16 were considered evaluable because they returned for at least one assessment after starting the intervention. The registry does not explain in detail why these counts differ from the recorded enrollment or identify the evaluable participants’ outcome values. The study is marked completed, but completion status does not itself indicate what the numerical findings were.
The design should be read as an intervention study with within-group follow-up, not as an efficacy comparison between randomized arms. The registry record does not report further details about the protocol, recruitment flow, adherence, or analysis procedures beyond the stated design and outcome descriptions.
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: Of the 29 subjects consented, 7 were found to be ineligible at the screening visit.
Overall Study
| Stage | Duloxetine |
|---|---|
| STARTED | 22 |
| COMPLETED | 13 |
| NOT COMPLETED | 9 |
Reasons for not completing this period:
| Reason | Duloxetine |
|---|---|
| Lost to Follow-up | 4 |
| Withdrawal by Subject | 4 |
| Physician Decision | 1 |
Analysis population for the primary outcome, as defined in the registry: Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.
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: Of 29 subjects who consented, 7 were ineligible at the screening visit. Out of the 22 remaining subjects, 19 received study medication.
| Characteristic | Unit | Duloxetine |
|---|---|---|
| Participants analysed | 19 | |
| Age, Continuous | years | 52.1 (SD 5.4) |
| Sex: Female, Male: Female | Participants | 19 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: United States | participants | 19 |
| Marital Status: Married | participants | 3 |
| Marital Status: Separated/divorced/widowed | participants | 5 |
| Marital Status: Never married/single | participants | 8 |
| Marital Status: Decline to answer | participants | 3 |
| Education: Less than high school degree | participants | 1 |
| Education: High school diploma or GED | participants | 5 |
| Education: Some college | participants | 9 |
| Education: Bachelor's degree | participants | 4 |
| Employment Status: Full- or part-time work | participants | 4 |
| Employment Status: Homemaker | participants | 4 |
| Employment Status: Unemployed/disabled | participants | 7 |
| Employment Status: Student | participants | 1 |
| Employment Status: Volunteer | participants | 1 |
| Employment Status: Retired | participants | 2 |
| Menopause Status: Perimenopausal | participants | 11 |
| Menopause Status: Naturally Postmenopausal | participants | 7 |
| Menopause Status: Surgically Postmenopausal | participants | 1 |
| Past hormone therapy use: Yes | participants | 1 |
| Past hormone therapy use: No | participants | 18 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression, measured over Baseline to week 9.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | units on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change in depression scores on the Hamilton Rating Scale for Depression from baseline to week 9. The HAM-D is described in the registry as a 17-item measure of current depressive symptoms and their severity. Eight items use a five-point scale scored from 0-4, and nine use a three-point scale scored from 0-2; the total score ranges from 0-50. A higher score indicates greater symptom severity.
In general, a structured rating scale gives investigators a consistent way to assess symptoms across participants and assessment occasions. A change score focuses on how a participant’s measured score differs over the specified follow-up interval, while a group summary can describe the distribution of those changes. The registry identifies the median and inter-quartile range as the summary form for this outcome. The median describes the middle of the observed values, and the inter-quartile range describes the spread of the central portion of those values.
The endpoint is clinically relevant to the study’s stated objective because it measures depressive symptom severity in the intended population. However, the registry record does not report the median change, its inter-quartile range, or other numerical primary-outcome results. It is therefore not possible from this record to characterize the direction, magnitude, or precision of the measured change.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary outcome and a follow-up timeframe, but it does not report the numerical primary-outcome findings. In particular, it gives no median change in HAM-D score and no inter-quartile range for that change. There is consequently no posted estimate in this record from which to describe the direction or magnitude of the observed change, or its precision. The study’s stated hypothesis is not itself evidence that the predicted result occurred.
The outcome population description is important when interpreting the study. The record lists enrollment of 29, says 19 participants received study medication, and identifies 16 as evaluable for analyses because they returned for at least one assessment after intervention began. Those counts should not be treated as interchangeable. The registry does not explain all transitions between them or give outcome data for those who were not evaluable. The denominator and handling of missing measurements for any particular analysis are not reported in the registry record.
The single-group structure also constrains interpretation. A before-and-after change, if reported, would be a description of participants’ scores over time after the intervention began. Without a concurrent comparison group, that pattern alone cannot separate the intervention’s contribution from natural symptom fluctuation, expectations, changes in care, or other time-related influences. This is a general limitation of interpreting within-group change, not a finding about what happened in this study.
The registry does report safety counts. In the Duloxetine group, 0 of 22 participants at risk were recorded as affected by a serious adverse event. For other adverse events, 9 of 22 at risk were recorded as affected. These registry counts describe recorded events in the listed safety population; they do not supply details about event types, severity beyond the serious-event classification, timing, or causal attribution. Deaths are not reported in the registry record.
The study is marked completed, and the record lists 5 outcome measures and 0 analyses. Completion indicates the registry status, not the presence of interpretable numerical outcome results. The record does not report a treatment-versus-control estimate, a confidence interval, or a hypothesis-test result for the primary outcome. The available information therefore supports description of the design and selected safety counts, but not a numerical assessment of the primary symptom outcome or a causal treatment conclusion.
9. Statistical Methods Explained
The record identifies the primary outcome as a change score summarized by the median and inter-quartile range. These summaries answer different questions. The median represents the central location of observed change values, while the inter-quartile range describes their dispersion. This approach can be informative when a distribution is skewed or when extreme values could pull a mean away from the typical observation. The registry does not report the actual median or inter-quartile range for the primary outcome, so those summaries cannot be interpreted for this trial from the recorded details.
In general, dispersion matters because a central estimate alone does not show how consistent participant outcomes are. A narrow spread indicates less variation among the central observations than a wide spread; a wide spread indicates that participant changes differ more. This is a general explanation, not a description of the unreported outcome distribution in this study. The record specifies the inter-quartile range as the dispersion measure but gives no numerical range.
A confidence interval, in general, is an interval estimate expressing uncertainty around an estimated quantity under a specified statistical procedure. It is not a guarantee that the true value lies within its endpoints. The registry entries do not include a confidence interval for the HAM-D change, and no interval should be inferred from the planned summary statistics alone. Without an estimate and its uncertainty, the precision of the primary outcome cannot be evaluated from this record.
The registry describes a single-group model, allocation as NA, and masking as none. In a single-group study, participant outcomes can be assessed over time, but there is no concurrent randomized group to estimate what would have happened over the same period under a different assigned treatment. General causes of within-group change can include the underlying course of symptoms, measurement variability, expectations, and other changes during follow-up. These are interpretive possibilities, not reported explanations for this trial.
The trial’s stated schedule includes a one-week placebo lead-in before duloxetine treatment. The arm description then gives duloxetine 30 mg per day for one week, followed by 60 mg per day for 7 weeks. The registry does not describe the lead-in as a randomized comparison or identify a placebo control arm during the intervention. Accordingly, it should not be interpreted as a parallel placebo-controlled design.
The planning assumptions recorded for sample-size illustrations describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of an observed effect. For time-to-event illustrations, the stated approach uses a total event count under Schoenfeld; other illustrations are expressed as participants per arm. These are planning assumptions, not a description of the study’s observed analysis. In particular, equal allocation between two arms does not match the recorded single-group structure as a like-for-like account of this trial. The illustrations are not observed power, and no actual illustration values are included in the registry record for this analysis.
General power calculations concern the chance that a planned analysis will detect an effect of a specified size under its assumptions. A planning illustration is not evidence that a study did or did not detect its target effect, and it cannot replace the observed estimate and uncertainty. Because the registry record does not report the primary-outcome estimate or test result, no observed power statement or retrospective conclusion about statistical significance can be made.
The record identifies a median and inter-quartile range, but does not report whether the analysis used a particular model, adjustment set, or test. It also does not say how repeated observations were handled, whether any sensitivity analyses were performed, or how outliers were treated. These details are not reported in the registry record and should not be inferred from the outcome label alone.
Over-dispersion is a general issue for some statistical models: observed variation can exceed what a model assumes, which may make standard errors too small and confidence intervals too narrow if the mismatch is ignored. No model or evidence of over-dispersion is reported for this trial, so the concept is relevant only as general statistical context, not as a diagnosis of the study analysis.
Likewise, adjustment for baseline values or prognostic factors can sometimes improve precision or account for imbalance in comparative studies. The record does not specify whether adjustment was used, and there is no randomized comparator for assessing between-group balance. It would be inappropriate to assume an adjusted analysis or to reconstruct one from the available summary information.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 5 outcome measures, identifies the HAM-D change as primary, and names change in menopause symptoms measured by the Greene Climacteric Scale as a secondary outcome. When several outcomes or analyses are considered, the chance of at least one apparently unusual result can increase if each is tested separately without accounting for multiplicity. This is a general statistical concern. The registry record does not report a multiplicity adjustment, a hierarchy of secondary outcomes, or which analyses were prespecified beyond the primary outcome description.
The record lists 0 analyses and does not give numerical results for the primary endpoint. It also does not specify a statistical analysis plan, hypothesis-testing procedure, or interim-analysis approach. Those details are not reported in the registry record; their absence from this record should not be replaced with assumptions about what investigators may have planned or conducted.
Missing-data information is limited. The primary-outcome description says 19 participants received study medication and that 16 were considered evaluable because they returned for at least one post-intervention assessment. The record does not explain why the remaining participants were not evaluable, how many measurements were missing at each assessment, or whether missing values were imputed, excluded, or otherwise handled. It also does not report an analysis population beyond that evaluability statement.
In general, missing outcomes can affect interpretation if the likelihood of missingness is related to symptoms or treatment experience. That is a methodological concern, not evidence that missingness was biased in this study. With no reported participant-level outcome pattern or missing-data method, the effect of missing observations on the primary estimate cannot be assessed from the registry 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 |
|---|---|---|---|
| Duloxetine | 0 | 22 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Duloxetine | 9 of 22 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Duloxetine |
|---|---|---|
| Gastrointestinal Discomfort | Gastrointestinal disorders | 7 of 22 |
| Dry Mouth | Gastrointestinal disorders | 5 of 22 |
| Muscle tension and aches | Musculoskeletal and connective tissue disorders | 2 of 22 |
The registry safety figures list a Duloxetine group with 22 participants at risk for the serious-adverse-event summary and 0 affected. For other adverse events, the listed at-risk count is 22 and the affected count is 9. These are counts as recorded in the registry, not estimates of comparative risk: the study has no concurrent control group in the described design.
A count of 0 affected by serious adverse events in the listed safety group means that no such affected participants are recorded in this registry summary. It does not establish that serious events are impossible or that no events could occur in another population. The record does not provide event-level descriptions, timing, duration, or attribution details. No serious-event terms are listed.
The other-adverse-event figure is a separate category from the serious-event figure. The registry does not list the specific other events in the registry record recorded for this analysis, so their nature and clinical importance cannot be characterized. Deaths are not reported in the registry record. These safety summaries should be interpreted as limited registry reporting, not as a complete account of tolerability or a comparison with another treatment.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed phase 4, single-group study examined duloxetine in symptomatic menopausal women. It identifies a primary measure of depression symptom change and a specified baseline-to-week-9 timeframe. It also records the planned dose sequence and selected adverse-event counts. These details describe the study’s purpose and design, but they are not a substitute for numerical outcome results.
The primary HAM-D result is not reported in the registry record. Without its observed summary, it is not possible to say whether scores changed, in which direction they changed, how large any change was, or how variable the changes were. The study hypothesis that symptoms would improve is a statement of intent, not a result. The secondary menopause-symptom measure is named, but numerical results for it are also not included in the registry record recorded for this analysis.
Even if a within-group change were available, the design would not by itself establish that duloxetine caused that change. A single-group before-and-after pattern has no concurrent randomized control to help distinguish intervention effects from other influences over time. This limitation does not mean that the study provides no information; it means that causal interpretation would require caution and cannot be based on an unreported result.
The safety summary records 0 affected by serious adverse events among 22 at risk and 9 affected by other adverse events among 22 at risk. These counts do not provide a comparison against another group, and the registry information does not describe the specific other events. They therefore offer a limited account of recorded safety outcomes rather than a broad conclusion about safety.
The enrollment, treatment-received, and evaluable counts are not identical in the record, and the reasons and analysis handling are not fully described. That limits assessment of how complete the outcome data were. Overall, the registry record documents the study question, intervention, endpoint, and selected safety counts, but not enough numerical efficacy information to characterize the primary result or its precision.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why study design and result availability both matter. The registry states a clear symptom-focused question and defines a primary outcome, but the record does not include the numerical outcome summary. Naming an endpoint and its assessment timeframe does not reveal the observed effect. Readers need the estimate and information about variability or uncertainty to judge what the data show.
The single-group design is also central to interpretation. A within-group assessment can describe participants’ measurements over time, but it does not provide the same evidence as a randomized comparison with a concurrent control. This distinction is especially important when the study’s objective is framed around whether an intervention reduces symptoms: a change over time and a treatment effect are not interchangeable concepts.
The registry’s different population counts illustrate why denominators need context. It records an enrollment of 29, reports 19 participants receiving study medication, and describes 16 as evaluable for analyses after returning for at least one assessment. The record does not fully explain the flow between these groups. Clear reporting of the analysis population and missing-data handling helps readers understand which observations support an endpoint summary.
The safety counts offer another lesson: event categories and denominators should be read as reported, without turning a single-group count into a comparative risk estimate. The serious and other adverse-event summaries are distinct, and the specific other events are not described in the recorded details.
Finally, planning assumptions should remain separate from evidence about observed results. Sample-size illustrations are planning aids based on stated assumptions, not observed power or outcome findings. This record does not report the primary estimate needed to assess the result’s magnitude or precision. Statistically, the most important conclusion is therefore about the limits of the available record: the design and selected counts are described, while the primary numerical outcome is not.
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 trial-specific limitations follow directly from the registry record. The study is recorded as single-group, with allocation listed as NA and masking as none. There is no concurrent control group described for the intervention period, so a within-group change, if reported, could not by itself establish a causal effect of duloxetine. The placebo lead-in is part of the stated sequence before treatment and is not described as a randomized comparator.
The most consequential reporting limitation is that numerical results for the primary HAM-D endpoint are not reported in the registry record. The median and inter-quartile range are identified as the intended summary, but their values are absent. The record also does not provide a confidence interval, test result, or numerical secondary outcome findings. Thus, neither magnitude nor precision can be assessed in the registry record recorded.
Population accounting is incomplete. The registry lists enrollment of 29, while the primary-outcome description refers to 19 participants who received study medication and 16 evaluable participants. It explains evaluability as returning for at least one assessment after intervention began, but does not describe all reasons for non-evaluability or the treatment of missing measurements. This makes it difficult to assess the extent or possible influence of missing outcome data.
Other details that would help interpretation are not reported in the registry record: the statistical analysis plan, specific hypothesis tests, adjustment methods, sensitivity analyses, and a multiplicity strategy. The safety information is also limited to summary counts; specific other adverse events, their timing, and deaths are not reported in the registry record. These limitations define what can be concluded from the recorded information and should not be replaced by assumptions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Duloxetine for Menopausal Depression — NCT01117857.
- Registry record last updated 2014-08-21; status last verified 2014-08.
- Results first posted 2014-08-21.
- 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
NCT01117857, “Duloxetine for Menopausal Depression,” is listed as a completed phase 4, single-group study sponsored by Massachusetts General Hospital. The registry records enrollment of 29, a study start of 2009-08, and primary completion in 2011-06. The intervention description specifies a placebo lead-in followed by duloxetine 30 mg per day for one week and 60 mg per day for 7 weeks.
The primary endpoint is change in HAM-D depression scores from baseline to week 9, summarized by median and inter-quartile range. The registry describes 19 participants as receiving study medication and 16 as evaluable. Numerical primary-outcome results are not reported in the registry record. Safety summaries list 0 of 22 affected for serious adverse events and 9 of 22 affected for other adverse events; deaths are not reported in the registry record.