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 Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents (NCT02586688), a randomized na study. The primary outcome is Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02586688 |
| Phase | NA |
| Condition | Major Depressive Disorder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 112 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Neuronetics |
| Results posted | Yes |
2. Clinical Question
Population
Adolescents meeting criteria for major depressive disorder were the population of interest. The registry lists 112 participants enrolled. It also describes an open-label population that continued treatment for maintenance; that population was not analyzed for the primary treatment effect.
Intervention
The active intervention was NeuroStar® transcranial magnetic stimulation, described as daily active TMS. The active arm is identified as Phase I TMS Active, with a blinded active TMS coil.
Comparator
The comparator was sham NeuroStar® transcranial magnetic stimulation. The sham arm is identified as Phase I TMS Sham, with a blinded sham TMS coil. The trial is described as randomized and sham-controlled.
Primary question
The primary outcome was change from baseline in the total Hamilton Depression Rating Scale-24 score at 6 weeks. The registry’s objective was to evaluate the safety and efficacy of daily active TMS compared with sham treatment. The posted arm summaries report least-squares mean changes of -11.1 for active TMS and -10.6 for sham. The posted unadjusted comparison is a mean difference of -0.5, with a confidence interval from -6.085 to 5.085 and p = 0.861. These results describe the posted measure and its precision; they do not, on their own, establish a treatment effect or its absence.
3. Trial Design
The registry describes a randomized, parallel-group, sham-controlled trial with quadruple masking. Participants were assigned to active NeuroStar® TMS or sham TMS. The arm descriptions specify blinded active and sham coils, but the registry record does not explain which participant, investigator, or other roles were included in the quadruple masking designation.
The condition listed is major depressive disorder, and the trial title identifies adolescents as the intended population. The registry lists 112 participants enrolled. The posted primary outcome summaries include 48 participants in the active arm and 55 in the sham arm. The record does not explain the difference between the overall enrollment figure and the arm counts used for the outcome summaries, so no reason for that difference can be inferred from these entries.
The listed study phase is NA. The record gives a start date of 2015-10, a primary completion date of 2018-01, and a status of completed. It lists Neuronetics as the sponsor. These registry entries describe the administrative and design context; they do not establish when individual participants were assessed or how long each participant remained in treatment beyond the stated primary outcome timeframe.
The primary outcome was assessed at 6 weeks and was the change from baseline in HAMD24 total score. The registry also notes an open-label population continuing treatment for maintenance, but explicitly says that population was not analyzed for the primary treatment effect. The record lists one outcome measure and no posted analyses. Details such as the randomization procedure, allocation concealment, trial protocol, analysis population definition, and the original sample-size justification 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.
Before assignment: Data regarding Phase 2 and phase 3 of the study is not available. Primary analyses for the phase 1 data showed the study didnt meet its primary end point and hence no further analyses was done.
Overall Study
| Stage | TMS Active | TMS Sham |
|---|---|---|
| STARTED | 54 | 58 |
| COMPLETED | 48 | 55 |
| NOT COMPLETED | 6 | 3 |
Reasons for not completing this period:
| Reason | TMS Active | TMS Sham |
|---|---|---|
| Lost to Follow-up | 2 | 1 |
| Withdrawal by Subject | 1 | 1 |
| Adverse Event | 3 | 1 |
Analysis population for the primary outcome, as defined in the registry: Open Label population not analyzed for primary treatment effect. Continued treatment for maintenance
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 | TMS Active Arm | TMS Sham Arm | Total |
|---|---|---|---|---|
| Participants analysed | 48 | 55 | 103 | |
| Age, Categorical: <=18 years | Participants | 27 | 35 | 62 |
| Age, Categorical: Between 18 and 65 years | Participants | 21 | 20 | 41 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 17.6 (SD 2.28) | 17.2 (SD 2.22) | 17.4 (SD 2.25) |
| Sex: Female, Male: Female | Participants | 30 | 37 | 67 |
| Sex: Female, Male: Male | Participants | 18 | 18 | 36 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: United States | participants | 48 | 55 | 103 |
| The Hamilton Rating Scale for Depression (HRSD) | units on a scale | 28.8 (SD 5.75) | 29.5 (SD 6.69) | 29.15 (SD 6.22) |
6. Primary Endpoint
The registry lists the primary outcome as Hamilton Depression Rating Scale-24(HAMD24) Total Score Change From Baseline Value., measured over 6 weeks.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | Standard Error |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in the total score on the 24-item Hamilton Depression Rating Scale, abbreviated HAMD24 in the registry. The record describes the Hamilton Rating Scale for Depression as a multiple-item questionnaire used to indicate depression and guide evaluation of recovery. It states that the scale ranges from 76 to 0 and that a lower score is better. The reported timeframe for this endpoint is 6 weeks.
A change score expresses how the measured score differs from its baseline value. In general, a negative change on a scale for which lower scores are better corresponds to a decrease in the measured score. The registry reports least-squares mean changes for the two arms, along with standard errors. The record does not describe the model used to produce those least-squares means, so the adjustment variables and other modeling details are not reported in the registry record.
A continuous score can retain information across the scale rather than reducing participants to a simple category. In general, this can make it possible to compare average changes between randomized groups. However, a group average does not describe every participant’s experience, and the posted endpoint does not by itself show how many individuals improved or worsened. The registry record does not post secondary outcome results alongside the primary endpoint.
7. Results Posted in the Registry
- Phase I TMS Active: mean -11.10 versus -10.60 on control; difference -0.50 (95% CI -6.09 to 5.09), standardized effect d = -0.03; z-test p = 0.861.
Mean difference: Phase I TMS Active
95% CI: -6.09 to 5.09
Recalculated from the posted summary statistics
8. Statistical Interpretation
The active arm’s posted least-squares mean change was -11.1, with a standard error of 2.03. The sham arm’s posted least-squares mean change was -10.6, with a standard error of 2.0. Since lower HAMD24 scores are described as better, both posted mean changes are in the direction of a lower score from baseline. The between-arm comparison is more directly relevant to the randomized treatment contrast than either arm’s change considered alone.
The posted unadjusted mean difference is -0.5 for active TMS relative to sham, with a confidence interval from -6.085 to 5.085 and p = 0.861. The interval includes zero, which is the value corresponding to no difference in mean change between the arms. The p-value is not small under common statistical conventions. Together, these quantities do not provide clear evidence of a difference between the groups on this endpoint. They also do not prove that the groups are identical or that a meaningful difference is impossible: the interval remains compatible with a range of contrasts in either direction.
The direction of the difference needs to be read in the context of the score and the contrast definition. The estimate is negative for active relative to sham, but its magnitude is small compared with the uncertainty expressed by the interval. The point estimate alone should not be treated as a precise estimate of what would occur in other participants or settings. The record does not state a threshold for a clinically important change, so the clinical importance of any value within the interval cannot be determined from the registry result.
The comparison is identified as unadjusted, and the registry record does not describe the sponsor’s full analysis model or provide a separate sponsor analysis result. It also does not report secondary outcome findings. Consequently, the interpretation is limited to the posted primary score and its six-week comparison. The record says that the open-label maintenance population was not analyzed for the primary treatment effect, so its continued treatment cannot be used to extend the randomized comparison.
These results concern the measured score in the trial as reported. They do not establish whether TMS should be used, whether it is preferable for any individual, or whether effects persist beyond the stated timeframe. General interpretation of a randomized comparison depends on the quality of implementation, completeness of follow-up, and analysis choices; details of missing data handling, protocol deviations, and the analysis population are not reported in the registry record.
9. Statistical Methods Explained
What does the mean change represent?
The primary outcome is continuous: each participant has a HAMD24 score, and the outcome is the change from baseline. A group mean summarizes the average change among participants included in the reported arm summary. It does not imply that every participant had that change. In general, averages are useful for comparing groups, while distributions and individual responses can differ around those averages.
The registry labels the reported arm values as least-squares means. In general, a least-squares mean is an average estimated from a statistical model, rather than necessarily being the simple arithmetic average of the observed values. Model details matter because included covariates, handling of repeated measurements, and assumptions about missing observations can affect estimates. Those details are not reported in the registry record, so the exact model cannot be reconstructed from the endpoint entry alone.
How should the standard errors be understood?
The active and sham arm summaries include standard errors of 2.03 and 2.0. In general, a standard error describes the statistical uncertainty around an estimated mean: it reflects how much the estimate would vary across repeated samples under a specified model and its assumptions. It is not the same as the spread of participant scores. The registry lists standard errors as the dispersion measure but does not provide standard deviations for the primary arm summaries.
What does the group comparison say?
The comparison is a mean difference between active TMS and sham. Its posted estimate is -0.5. The comparison summary also gives a pooled standard deviation of 14.48 and indicates that this standard deviation is approximate. A pooled standard deviation describes a combined measure of variability across groups; here it supports a standardized comparison but is marked as approximate. The standardized effect estimate is not repeated because its recorded precision exceeds the limit used in this explanation.
The comparison summary includes a confidence interval from -6.085 to 5.085 and an unadjusted p-value of 0.861. In general, an unadjusted result is not corrected for testing multiple outcomes or comparisons. The p-value assesses how compatible the observed data are with a specified null hypothesis under the assumptions of the test; it is not the probability that the null hypothesis is true. The registry does not identify the test procedure or report an adjusted p-value.
Why does the confidence interval matter?
A confidence interval gives a range of estimates compatible with the data under the method used to calculate it. In general, a wider interval indicates less precision, while a narrower interval indicates greater precision. This interval spans values on either side of zero, so the data are compatible with an active-versus-sham mean difference in either direction. The range is broad relative to the point estimate, and the estimate should therefore not be interpreted as a precise measure of the contrast.
The registry comparison summary includes an unadjusted recalculation based on posted summary statistics. Such a recalculation is not a substitute for a trial’s prespecified model or a complete participant-level analysis. No discrepancy is flagged for this result. The analysis details needed to assess whether the posted estimate matches the trial’s planned primary analysis are not reported in the registry record.
What do the planning calculations represent?
The planning illustration uses the observed effect as its reference and considers detecting a stated fraction of that effect. The stated assumptions are a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. In general, these calculations estimate how many participants might be needed under those assumptions to achieve a chosen probability of detecting an effect if that effect is present. They are hypothetical planning values, not a description of the trial’s original design or its achieved ability to detect an effect. The original design assumptions and sample-size justification are not reported in the registry record.
For continuous outcomes, a normal approximation treats the estimate as having a sampling distribution that can be approximated by a normal distribution under the calculation assumptions. Real trial data may not match all such assumptions. The record does not report checks of the distributional assumptions, protocol-specified analysis details, interim analyses, or adjustment for multiplicity. These omissions limit how completely the registry results can be assessed statistically.
10. Confidence Intervals and Precision
The posted estimate of the active-versus-sham mean difference is -0.5. Its confidence interval extends from -6.085 to 5.085. In general, the interval represents uncertainty about the estimated difference, conditional on the method and assumptions used to calculate it. Because it includes zero and values in both directions, the result does not pin down whether the average change favored active TMS or sham. The interval is more informative than the point estimate alone because it displays the range of contrasts compatible with the data under the calculation method.
The unadjusted p-value is 0.861. A p-value is not a measure of effect size or clinical importance, and it does not state the probability that there is no difference. It describes how unusual the data would be under a null hypothesis and the test’s assumptions. The record does not identify the precise test procedure or provide an adjusted result.
The arm summaries report standard errors of 2.03 for active TMS and 2.0 for sham. In general, standard errors describe precision of estimated means, not the variability among individual participants. The confidence interval for the difference is broad enough to include a range of possible contrasts; the result should not be read as a precise demonstration of equivalence. The registry does not report a prespecified equivalence margin or a clinically important difference threshold.
Confidence intervals depend on the statistical model and data handling. The registry record does not report the model specification, missing-data method, or analysis population details needed to assess those assumptions. The interval describes uncertainty for the posted comparison, not uncertainty about all possible outcomes, populations, or timeframes.
11. Planning a Similar Trial: Sample Size
This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.
| Effect to detect | Participants per arm, 80% power | Participants per arm, 90% power |
|---|---|---|
| 100% of the observed effect | 13,166 | 17,625 |
| 75% of the observed effect | 23,406 | 31,333 |
| 50% of the observed effect | 52,662 | 70,500 |
The planning values are participants per arm, not total events. The calculation is an illustration based on the observed effect, with the effect to detect set to a stated fraction of that observed effect. Its assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The original trial design assumptions and sample-size justification are not reported in the registry record.
The 80% power column means the number of participants per arm estimated to give an 80% chance of detecting the specified effect under the calculation assumptions, if that effect is present. The 90% power column gives the corresponding planning number for a 90% chance. These are conditional planning probabilities, not guarantees about a future trial. They depend on the assumed effect size and the calculation method.
For planning at 100% of the observed effect, the illustration gives 13,166 participants per arm for 80% power and 17,625 per arm for 90% power. At 75% of the observed effect, the values are 23,406 and 31,333 participants per arm. At 50% of the observed effect, the values are 52,662 and 70,500 participants per arm. The pattern reflects a general principle: smaller effects are harder to distinguish from random variation and therefore require more participants to reach the same target power, all else being equal.
This is not observed power. It is not a retrospective measure of what the completed trial achieved, and it does not change the interpretation of the posted estimate and confidence interval. The registry record does not report the original design’s power target or assumptions.
12. How the Sample Size Is Derived
Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z1−α/2 = 1.960) and the desired power (z1−β = 0.842 for 80% and 1.282 for 90%).
Formula
n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.
Worked calculation for this trial
- Observed difference Δ = -0.500; pooled standard deviation σ = 14.480.
- n = 2 × (1.96 + 0.842)2 × 14.4802 / -0.5002 = 13,165.4, rounded up to 13,166 participants per arm for 80% power.
The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).
R code
alpha <- 0.05
z_a <- qnorm(1 - alpha / 2) # two-sided
delta <- -0.5 # observed difference in means
sigma <- 14.4800136753942 # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))
# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")
# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2586688)
n <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n)) # difference in sample means
s2 <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1)) # pooled sample variance
tstat <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))
Output from running the code
100% of observed effect: n per arm = 13,166 (80% power), 17,625 (90% power)
75% of observed effect: n per arm = 23,406 (80% power), 31,333 (90% power)
50% of observed effect: n per arm = 52,662 (80% power), 70,500 (90% power)
power.t.test: 13166.4
Simulated power at n = 13,166 per arm: 0.799 (20000 replicates)The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.
13. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and no posted analyses, while the primary endpoint has an accompanying arm summary and comparison. It lists no secondary outcome results. The record does not describe a broader prespecified analysis plan, so the number of outcomes or comparisons originally planned cannot be established from the registry record.
Multiplicity arises when researchers test multiple outcomes, timepoints, subgroups, or comparisons. In general, the more tests performed, the greater the chance that at least one result appears notable by chance. Statistical plans may address this through prespecification or adjustment, but the registry record does not report a multiplicity strategy. The posted comparison is unadjusted; this should not be mistaken for evidence that no other analyses were conducted.
Missing data can affect a randomized comparison if the availability of outcome measurements differs between groups or relates to participants’ outcomes. In general, analysis methods make assumptions about values that were not observed. The registry does not report the amount or pattern of missing primary outcome data, the method used to handle missingness, or sensitivity analyses. It also does not state the analysis population definition, such as whether the primary comparison included all randomized participants or another set.
The primary endpoint summaries list 48 participants in the active arm and 55 in the sham arm, while the overall enrollment is 112. These figures should not be treated as an explanation of participant flow: reasons for differences among enrolled, randomized, treated, and analyzed participants are not reported in the registry record. A participant flow description and reasons for exclusion or non-completion would help interpret how the analysis set was formed.
The record identifies the open-label maintenance population as not analyzed for the primary treatment effect. It does not report interim analyses, stopping rules, protocol deviations, or a detailed statistical analysis plan. Without these details, the posted result can be described, but its full relationship to the trial’s planned analyses cannot be assessed.
14. 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 |
|---|---|---|---|
| TMS Active Arm | 3 | 54 | 5.6% |
| TMS Sham Arm | 1 | 58 | 1.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| TMS Active Arm | 0 of 54 |
| TMS Sham Arm | 0 of 58 |
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 |
|---|---|
| TMS Active Arm | 31 of 54 |
| TMS Sham Arm | 19 of 58 |
Most frequent serious adverse event terms
| Event term | Organ system | TMS Active Arm | TMS Sham Arm |
|---|---|---|---|
| Suicidal Ideation- not related to study device | Psychiatric disorders | 1 of 54 | 1 of 58 |
| Suicide Attempt (classified as definitely not related to the study device) | Psychiatric disorders | 1 of 54 | 0 of 58 |
| Worsening Depression- classified as definitely not related to the study device | Psychiatric disorders | 1 of 54 | 0 of 58 |
Most frequent non-serious adverse event terms
| Event term | Organ system | TMS Active Arm | TMS Sham Arm |
|---|---|---|---|
| Headache | Nervous system disorders | 17 of 54 | 10 of 58 |
| Nausea | Gastrointestinal disorders | 6 of 54 | 3 of 58 |
| Neck Pain | Musculoskeletal and connective tissue disorders | 3 of 54 | 3 of 58 |
| Vomiting | Gastrointestinal disorders | 3 of 54 | 2 of 58 |
| Twitching Facial | Gastrointestinal disorders | 4 of 54 | 1 of 58 |
| Eye Pain | Eye disorders | 3 of 54 | 0 of 58 |
Serious events with the highest arm-level rate: suicide attempt (classified as definitely not related to the study device) (1.9%), suicidal ideation- not related to study device (1.9%), worsening depression- classified as definitely not related to the study device (1.9%).
The safety record gives separate at-risk counts for the active and sham groups. For serious adverse events, 54 participants were at risk in the active arm and 58 in the sham arm; the numbers affected were 3 and 1, respectively. The listed number of deaths was 0 in each group. For other adverse events, the at-risk counts were 54 and 58, and the numbers affected were 31 and 19, respectively.
These are counts from the registry’s safety entries. They should be read with their stated at-risk denominators rather than with the primary outcome arm counts, which are different. The entries do not provide enough information to infer why those denominators differ. Counts of participants affected are not the same as counts of all event episodes if an individual could have more than one event; the registry record does not clarify that detail.
The listed serious-event terms include Suicide Attempt, classified as definitely not related to the study device, at 1.9%; Suicidal Ideation, described as not related to the study device, at 1.9%; and Worsening Depression, classified as definitely not related to the study device, at 1.9%. The registry does not specify the arm assignment for these terms in the listed entries. These entries are descriptive and should not be interpreted as proving or excluding a causal relationship beyond the classifications recorded.
15. What the Result Does, and Does Not, Mean
The primary result describes the average six-week change in HAMD24 score in the active and sham groups. The reported mean changes are close, and the unadjusted estimated difference is -0.5. The confidence interval, from -6.085 to 5.085, includes zero and spans values in either direction. The unadjusted p-value is 0.861. Taken together, the posted statistics do not give clear evidence of a difference between the groups on this measure, while leaving uncertainty about the size and direction of any underlying difference.
This does not establish that the treatments are equivalent. An equivalence conclusion generally requires a prespecified margin defining what difference would count as practically unimportant and an analysis designed to test that question. No equivalence margin is reported in the registry record. Nor does a non-small p-value prove that no difference exists. It indicates that the posted data do not distinguish the observed contrast from the null under the reported unadjusted comparison and its assumptions.
The result concerns a particular score, timeframe, and trial population. The endpoint is a depression rating scale, and the registry states that lower scores are better. A group-level mean does not show each participant’s response, nor does it establish how a change relates to outcomes not measured in the posted primary result. No secondary outcome results are listed.
The registry describes the study as completed and randomized, with sham control and quadruple masking. Those design features provide context for interpreting a group comparison, but the record does not report enough methodological detail to assess the randomization process, missing-data handling, or analysis population. The open-label maintenance population was not analyzed for the primary treatment effect, and the result does not address whether any difference persists beyond the stated 6 weeks.
These statistics are a description of the posted trial outcome, not a recommendation or a basis for individual treatment decisions. The record does not report a clinically important difference threshold, and the interval’s clinical interpretation therefore remains uncertain. The safety entries are separate descriptive counts and should not be conflated with the primary efficacy comparison.
16. Why This Trial Matters Statistically
This trial illustrates why an arm’s change from baseline and a randomized between-arm comparison answer different questions. Both groups had negative mean changes on a scale for which lower scores are better. The central statistical question is not whether either group changed from baseline, but whether the change differed between the active and sham groups. The posted difference is -0.5, and its uncertainty is expressed by an interval spanning zero.
The example also shows why a point estimate should be read together with its precision. A single estimate can suggest a direction, but it cannot convey the range of effects compatible with the data. Here the interval is wide enough to include contrasts on either side of zero. The p-value alone would not communicate that range, nor would it establish clinical importance.
The registry’s planning illustration further demonstrates how assumed effect size shapes sample-size needs. Under its stated assumptions, planning for a smaller fraction of the observed effect requires more participants per arm. This is a planning relationship, not evidence about the trial’s original design. The original sample-size justification is not reported in the registry record, so the illustration should not be mistaken for the enrollment target that investigators selected.
Finally, statistical interpretation depends on reporting beyond the headline result. Details about the analysis model, missing data, multiplicity, and the analysis population help readers understand what the estimate represents and how robust it may be. Those details are not reported in the registry record. Recognizing both the information present and the information absent is part of interpreting a clinical trial responsibly.
17. 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 gives a concise primary outcome result but does not report a full statistical analysis plan. The specific model behind the least-squares means, the covariates included, and the handling of repeated measurements are not reported in the registry record. This limits assessment of how the arm estimates were produced and whether the comparison follows a prespecified approach.
The record does not describe participant flow or reconcile overall enrollment of 112 with the primary arm counts of 48 and 55. It also does not report missing outcome counts, reasons for missingness, or how missing observations were handled. The analysis population and the number of participants randomized to each arm are not reported in the registry record.
There are no posted secondary outcome results and no posted analysis count. The record does not report whether other outcomes, timepoints, subgroup analyses, or interim analyses were planned or conducted, or whether any multiplicity adjustment was used. The primary comparison is unadjusted, and the statistical test procedure is not specified.
The registry notes an open-label population that continued treatment for maintenance and was not analyzed for the primary treatment effect. It does not provide an additional primary treatment-effect analysis for that population. The posted result is therefore limited to the stated six-week primary endpoint and should not be extended to maintenance treatment or longer-term outcomes.
The safety entries use at-risk counts that differ from the primary outcome arm counts, and the record does not explain the difference. The listed serious adverse event terms do not identify an arm in the entries, limiting group-specific interpretation of those terms. The trial’s original sample-size rationale, recruitment or retention details, protocol deviations, and clinically important difference threshold are not reported in the registry record.
18. Related Tutorials
19. Related Statistical Calculators
20. Sources
- ClinicalTrials.gov: Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents — NCT02586688.
- Registry record last updated 2025-06-12; status last verified 2025-05.
- Results first posted 2025-06-12.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
21. Record Summary
NCT02586688 is a completed randomized, parallel, sham-controlled trial sponsored by Neuronetics. The registry lists adolescents with major depressive disorder as the population and 112 participants enrolled. Active NeuroStar® TMS was compared with sham TMS under quadruple masking. The listed study phase is NA.
The primary outcome was change from baseline in HAMD24 total score at 6 weeks, with lower scores described as better. The arm summaries report least-squares mean changes of -11.1 for active TMS and -10.6 for sham. The posted unadjusted mean difference is -0.5, with a confidence interval from -6.085 to 5.085 and p = 0.861. The registry also reports serious and other adverse event counts for the two groups, with 0 deaths listed in each.
The record lists one outcome measure and no posted analyses or secondary outcome results. Further information about the statistical model, missing-data handling, analysis populations, multiplicity, and the trial’s original sample-size assumptions is not reported in the registry record.