Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset (NCT01842542), a na na study. The primary outcome is Mean Change in EPDS Score From Baseline to End of Acute (EOA) Treatment.

2. Clinical Question

This design can describe scores and safety events recorded during treatment among the enrolled participants. Without a control group, a change over time cannot by itself separate an intervention effect from other explanations, such as natural changes in symptoms or the effects of concurrent care. The registry record does not report whether concurrent treatments were permitted or recorded, so their role cannot be assessed from this record.

3. Trial Design

This was an open-label, single-group device study of NeuroStar TMS in patients with major depressive disorder with postpartum onset. The registry lists the allocation as “NA,” masking as “NONE,” and the model as “SINGLE GROUP.” These entries are consistent with a study in which no blinded or randomized control comparison is described. The enrollment listed in the record is 25.

The intervention description says patients would receive TMS treatments 5 times a week for up to 8 weeks during the acute phase. It also describes a taper phase with treatment 3 times during the first week, 2 times during the second week, and 1 time during the third week. The record does not clarify whether every participant completed the full acute schedule or taper. The primary endpoint timeframe is stated as pre to post treatment, with a duration range of 4 to 8 weeks.

The record lists a start date of 2013-12 and a primary completion date of 2015-07. Its status is “TERMINATED.” A reason for termination is not reported in the registry record. The planned purpose was to evaluate safety and effectiveness of acute NeuroStar TMS therapy in women with postpartum depression.

The design is important when interpreting any outcome. A single-group study can report observations over time within the enrolled group, but it does not provide a concurrent untreated or alternative-treatment group for comparison. Open-label status also means that masking is not described. The registry record does not report a randomized comparison or a like-for-like control arm. It therefore does not support a direct comparative estimate against another treatment or control condition.

The record lists one primary outcome and a secondary outcome concerning the percentage of patients who reached remission after TMS treatment. It lists 2 outcome measures and 0 analyses. Numerical results for the primary endpoint and the remission outcome are not reported in the registry record.

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:

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 Mean Change in EPDS Score From Baseline to End of Acute (EOA) Treatment, measured over Pre to post treatment (Duration range 4 to 8 weeks).

The primary endpoint is the mean change in EPDS score from baseline to the end of acute treatment. EPDS is a ten-item questionnaire used for screening for postpartum depression. Its total score ranges from 0 to 30. The record states that scores above 10 suggest likely depressive illness and scores above 13 likely represent major depression. It also states that higher scores at the end of acute treatment indicate a worse outcome.

The endpoint is measured on a score scale and summarized as a mean, with standard error listed as the dispersion measure. A change endpoint describes how scores differ between the baseline and follow-up assessments; however, the registry record does not specify the sign convention used to calculate that change. The numerical mean change and standard error are not reported in the registry record, so the direction and precision of the observed average change cannot be assessed.

The record describes the end of acute treatment as occurring when a patient reached remission, defined as EPDS <9, and says scores were collected at that point. The endpoint timeframe is listed as pre to post treatment over a duration range of 4 to 8 weeks. Because the assessment point may be tied to reaching remission, the record does not establish that every participant had an assessment at the same elapsed treatment time. The rationale for choosing the EPDS is its use as a postpartum depression screening questionnaire; the registry record does not report further measurement-validation details for this study.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a continuous measure: an EPDS score change summarized by a mean. For a continuous outcome, the mean describes the average value in the analyzed group. Here, the intended contrast is between baseline and the end of acute treatment within a single group. The registry record gives no numerical mean change, so there is no reported estimate to interpret. It also does not specify in the endpoint description whether the change was calculated as end minus baseline or baseline minus end. That sign convention matters because it determines whether a positive or negative change corresponds to a lower follow-up score.

The record lists standard error as the dispersion measure. In general, standard deviation describes variation among individual observations, while standard error describes uncertainty in an estimated mean. They answer different questions and should not be treated as interchangeable. Since no numerical standard error is reported, the variability of the observed participant scores and the precision of the mean cannot be reconstructed from the record.

In general, an interval estimate combines an estimate with an expression of its uncertainty. A confidence interval can help show which effect sizes remain compatible with the observed data under the analysis assumptions. It is often more informative than a thresholded significance test because it displays both direction and precision. No confidence interval is reported for this primary endpoint. The registry record also lists 0 analyses and does not report a p-value for the endpoint.

In general, a p-value assesses how surprising data at least as extreme as those observed would be under a specified null model and its assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. Since the record contains no reported endpoint analysis or p-value, no significance conclusion can be drawn from it. In this single-group design, even a within-group test would address change over time, not a randomized treatment-versus-control contrast.

The endpoint's assessment timing also affects interpretation. The stated timeframe is pre to post treatment, with a duration range of 4 to 8 weeks. The outcome description says end of acute treatment was when a patient reached remission, defined as EPDS <9, and scores were collected then. The record does not explain how assessment timing was handled for participants who did not reach that threshold, or whether a common follow-up time was used for all participants. Those details are not reported in the registry record.

The record includes planning assumptions for sample-size illustrations based on an observed effect: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. It states that time-to-event illustrations give total events and other illustrations give participants per arm. These are planning illustrations, not evidence of observed power, and the record does not report the resulting sample-size values. They should not be mistaken for the design of this single-group study, which has no two-arm allocation listed. The assumptions also do not establish that they were used to plan the trial; a sample-size justification for the trial itself is not reported in the registry record.

In general, over-dispersion arises when observed variability is greater than expected under a statistical model. If present, it can make model-based standard errors too small and uncertainty appear narrower than warranted. This general issue can matter for outcomes whose variability does not fit the assumed distribution. The registry record does not report an analysis model, a dispersion assessment, or enough outcome data to evaluate over-dispersion for this study.

The record does not describe an adjustment model, a method for handling repeated measurements, or a planned strategy for testing the primary endpoint. It also does not report an interim-analysis plan. These details are not reported in the registry record, so readers cannot check whether the analysis accounted for baseline values, differences in follow-up timing, or other covariates. No adjusted or recalculated result is reported. The appropriate statistical reading is therefore limited to the stated endpoint, design, and absence of a posted numerical analysis.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Open Label Transcranial Magnetic Stimulation (TMS)")
n   <- c(19)
m   <- c(-12.4)
sp  <- c(1.769)
sd  <- sp * sqrt(n)      # standard errors converted to SDs
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Open Label Transcranial Magnetic Stimulation (TMS)  19  -12.400  7.711  -16.117  -8.683

11. Multiplicity, Missing Data and Analysis Populations

The record lists a primary outcome and a secondary outcome: the percentage of patients who reached remission after TMS treatment. It lists 2 outcome measures, but 0 analyses. Numerical results for either outcome are not reported in the registry record. The record also does not describe a multiplicity strategy, such as prioritizing tests or adjusting interpretation when several outcomes are examined. Without reported analyses, it is not possible to assess how multiple outcomes were handled.

Missing-data methods and analysis populations are not reported in the registry record. The record does not state how many participants contributed baseline or end-of-acute-treatment EPDS scores, whether participants withdrew, or how incomplete observations were handled. It does not identify an intention-to-treat, per-protocol, or other analysis population. Enrollment of 25 therefore should not be read as confirmation that 25 participants had complete endpoint data or were included in an analysis.

These omissions matter because a change-score analysis depends on which participants have usable measurements and how incomplete follow-up is treated. In general, analyses restricted to participants with observed follow-up can differ from analyses that make explicit assumptions about missing values. The registry record does not report enough information to determine which approach, if any, was used. It also does not report sensitivity analyses assessing how conclusions might vary under alternative assumptions about missing observations.

The study status is “TERMINATED,” but the reason and the relationship of termination to recruitment, follow-up, or analysis are not reported in the registry record. No explanation should be inferred from the status alone.

12. 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 5% reporting threshold.

The registry record lists 25 participants at risk in the open-label TMS group. It reports 0 serious adverse events, 0 other adverse events, and 0 deaths in that group. These are the safety counts recorded for the listed group.

Zero reported events in these categories means that the registry record does not list any affected participants for those counts. It does not establish that no symptoms or events of any kind occurred: the figures distinguish serious from other adverse events, and the record does not provide event terms for either category. The list of top serious event terms is empty. The record does not describe how events were collected, how long participants were followed for safety, or how completeness of safety reporting was assessed.

These counts should be read alongside the study design and its enrollment, not as a comparative safety estimate. There is no control group listed, so the record does not provide a basis for comparing event rates between treatments. It also does not report a statistical analysis of safety outcomes. The counts describe what the registry record posts and do not establish the absence of risk or determine the safety profile beyond the reported categories and study record.

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

The record describes an open-label, single-group study of NeuroStar TMS in women with major depressive disorder with postpartum onset. It identifies a primary endpoint based on mean EPDS score change from baseline to the end of acute treatment and lists a secondary outcome concerning remission. It also reports enrollment of 25 and safety counts of 0 serious adverse events, 0 other adverse events, and 0 deaths among 25 participants at risk.

Those details do not supply the primary efficacy result. The mean change, its standard error, and any interval or test result are not reported in the registry record. The number of participants reaching remission is also not reported. As a result, the record does not show the observed magnitude or precision of the change in EPDS scores, and it does not permit a statistical assessment of the listed remission outcome.

Even if a within-group change were available, the single-group design would describe change during the study rather than isolate the effect of TMS relative to a control condition. The record lists no control group, randomization, or like-for-like comparison. Open-label status means masking is not described. Other explanations for changes over time cannot be ruled out through a randomized comparison that is absent from this record.

The safety counts likewise have a limited scope. They describe the reported serious and other adverse-event categories and deaths; they do not represent a comparative safety analysis or establish that no events outside those categories occurred. The record does not give event terms or further details about safety follow-up.

The study status is “TERMINATED,” but the reason for termination is not reported in the registry record. The findings that can be stated are therefore about the registered design, planned endpoint, enrollment, status, and posted safety counts. The clinical outcome and its statistical uncertainty cannot be characterized from the numerical results in this record.

14. Why This Trial Matters Statistically

This trial is statistically notable because it asks a focused within-group question while lacking a concurrent comparison group. A repeated measure such as EPDS can describe how scores change from baseline to follow-up, but the design determines what that change can mean. Without a control arm, change over time cannot be separated from other influences through a between-group comparison. This limitation is central to interpreting the endpoint, not a minor technical detail.

The record also illustrates why an outcome definition and a reported result are both needed. It specifies the EPDS, score range, direction of worse outcome, and a remission threshold used in the assessment description. Yet it does not report the mean change, its uncertainty, or the remission count. Endpoint definitions explain what investigators intended to measure; they do not show what the participants experienced.

Precision is particularly important for a study with an enrollment of 25. The registry record does not provide a confidence interval or standard error value, so readers cannot assess how precisely the mean change was estimated. The planning assumptions listed for sample-size illustrations are not a substitute for an analysis result or a trial-specific sample-size justification. The illustrations use a hypothetical two-arm framework, whereas the registered design is single-group.

Finally, the status “TERMINATED” and the absence of reported analyses make transparent reporting especially relevant. The registry record does not state why the study ended, how missing observations were handled, or which analysis population was used. Those gaps prevent readers from determining whether the listed enrollment corresponds to a complete outcome dataset. The record remains useful for understanding the intended question and design, while also showing the limits created by absent outcome and analysis details.

15. 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 registry record does not report numerical results for the primary mean EPDS change, its standard error, or any interval estimate. It also does not report the number or percentage of participants who reached remission. Consequently, neither the size nor precision of the primary outcome can be assessed from the posted record.

The design is open-label and single-group, with no control comparison listed. A within-group observation cannot provide a randomized comparison against another treatment or a control condition. The record does not report whether participants received concurrent treatments, and it does not describe additional factors that may have influenced scores during follow-up.

The primary endpoint timeframe spans 4 to 8 weeks, and the endpoint description ties the end-of-acute-treatment assessment to reaching remission, EPDS <9. The record does not explain how timing was handled across participants, including for those who may not have reached the specified threshold. It also does not state whether all participants had follow-up assessments.

Missing-data procedures, analysis populations, adjustment methods, and interim analyses are not reported in the registry record. The reason for the “TERMINATED” status is also not reported. These gaps limit assessment of completeness, analytic choices, and the relationship between the study's status and its results. The safety entries report zero serious and other adverse events and zero deaths, but do not give event terms or further information on ascertainment and follow-up.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Efficacy and Safety Study of NeuroStar TMS Therapy in Patients With Major Depressive Disorder With Postpartum Onset — NCT01842542.
• Registry record last updated 2025-02-10; status last verified 2025-01.
• Results first posted 2025-02-10.
• 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.

19. Record Summary

The registry record describes an open-label, single-group device study of NeuroStar TMS for major depressive disorder with postpartum onset. Enrollment is listed as 25; the status is “TERMINATED,” with a start date of 2013-12 and a primary completion date of 2015-07. The intervention description includes acute treatment up to 8 weeks and a taper schedule.

The primary endpoint is mean change in EPDS score from baseline to the end of acute treatment. A secondary outcome concerns the percentage reaching remission. Numerical outcome analyses are not reported, and the record lists 0 analyses. It reports 0 serious adverse events, 0 other adverse events, and 0 deaths among 25 participants at risk. The reason for termination, missing-data methods, and analysis populations are not reported in the registry record.