Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens (NCT01502033), a na na study. The primary outcome is Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal).

2. Clinical Question

The study is framed as an assessment of rTMS in depressed adolescents, including its safety and effectiveness and potential effects on neurobiology. The posted registry information identifies a clinical rating measure as the primary outcome. It does not, however, provide an analyzed change from baseline, a post-treatment mean, a measure of variability, or an estimate of uncertainty for that endpoint. Without those results, the record does not permit a quantitative assessment of the primary clinical outcome.

The single-group design is central to interpreting the question. A change measured during treatment could be described within the treated group, but a change alone would not establish what would have happened over the same period without rTMS or under another intervention. The record also does not report a comparator that could separate treatment-associated changes from other influences. The findings that can be drawn from this registry entry are therefore limited to the design, outcome definitions, and safety counts it reports.

3. Trial Design

The registry describes a completed, open-label, single-group study of repetitive transcranial magnetic stimulation in depressed adolescents with Major Depressive Disorder. Enrollment is listed as 10. The trial is not presented as a randomized comparison, and there is no concurrent control arm in the registered design. The phase is listed as NA. The registry record does not report a sample-size justification or explain how the planned enrollment was chosen.

The intervention is identified as a device, named Transcranial Magnetic Stimulation. The arm description specifies an open-label course of 30 daily rTMS treatments at 120% magnetic field intensity relative to the patient's resting motor threshold, delivered at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds. The description ends before completing its statement about the total number of trains, so that detail is not reported in the registry record.

Open-label means the study is not described as masking treatment assignment from participants or investigators. With a single group and no control condition, the design can describe measurements among people receiving the intervention, but it does not provide a randomized between-group estimate. The record does not report blinding of outcome assessors, so whether ratings were made by assessors unaware of treatment is not reported in the registry record.

The start date is listed as 2011-12 and primary completion as 2013-05; the overall status is COMPLETED. The registered primary outcome is the Children's Depression Rating Scale-Revised (CDRS-R) at post-treatment Treatment 30, or at the last treatment in cases of early withdrawal. Clinical Global Impression - Severity (CGI-S) after Treatment 30 or the last treatment, and the Clinical Global Impression - Improvement (CGI-I), are listed as secondary outcomes.

Although the record identifies three outcome measures, it lists no analyses. Numerical results for the primary and secondary outcomes are not reported in the registry record. The design and outcome schedule can therefore be described, but the posted registry information does not support a report of observed clinical outcome estimates.

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: Participants were maintained on stable dosage of antidepressant medication for 4 weeks prior to enrollment and rTMS treatment.

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 Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal), measured over 5 days of Treatment 30 or Last Treatment.

The primary endpoint is the Children's Depression Rating Scale-Revised (CDRS-R) after Treatment 30, or after the last treatment for participants who withdrew early. The registry describes the CDRS-R as a validated, 17-item, semi-structured clinician rating tool for assessing depression severity, with subject and parental input for 14 of the 17 items. The unit is listed as units on a scale, and the intended summary is a mean with a standard deviation.

A clinician-rated scale can provide a structured way to characterize symptom severity using a consistent set of items. The use of subject and parental input is part of the measure's stated assessment approach. A post-treatment score can describe status at the specified assessment time, but it is not by itself evidence of improvement. To assess change, an analysis would ordinarily need to relate the post-treatment measurement to a baseline measurement or another comparison. The registry record does not report a baseline CDRS-R result or a numerical post-treatment result.

The outcome timing allows for the last treatment to serve as the assessment point for early withdrawals, as described in the registry. This means the intended endpoint does not necessarily correspond to the same treatment exposure for every participant. The number of early withdrawals and the handling of their observations in the analysis are not reported in the registry record. The listed timeframe is “5 days of Treatment 30 or Last Treatment”; further detail about the timing window is not reported in the registry record.

Because the endpoint result and its analysis are absent, no mean, standard deviation, change estimate, or confidence interval can be interpreted from this registry entry. The outcome definition explains what was intended to be measured, not what the observed scores were.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation depends first on matching the analysis to the study design and to the outcome that was actually reported. The registry describes a single-group study and a continuous primary outcome summarized as a mean and standard deviation. A mean describes the center of a set of measurements, while a standard deviation describes how spread out individual measurements are around that center. Neither summary is posted for the primary endpoint, and no analysis is listed. Consequently, an effect estimate cannot be interpreted from the registry record.

What does a mean describe?

For a continuous measure such as the CDRS-R, the mean is an average score across the observations included in an analysis. Its interpretation depends on which observations were included, when they were collected, and whether the analysis concerns a single time point or change over time. The registry identifies a post-treatment time point, with the last treatment used for early withdrawals. It does not report the actual mean or specify an analysis population. A mean at the end of treatment would describe observed scores at that time; it would not alone describe change unless an appropriate baseline comparison were also made.

Why does the single-group design matter?

A between-group comparison asks how outcomes differ across groups assigned to different conditions. This record does not describe such a comparison. A within-group comparison instead examines measurements from the same group across time, if repeated measurements and an analysis are available. Even when a within-group change is estimated, it does not automatically identify a treatment effect. Without a concurrent comparator, changes associated with time, expectations, or other care cannot be separated by random allocation from changes associated with the intervention. These are general limitations of a single-group design, not claims that any particular alternative explanation occurred.

How should uncertainty be described?

A confidence interval is a statistical range expressing uncertainty around an estimate under the assumptions of the method used. In general, a narrower interval indicates greater precision and a wider interval indicates less precision. A confidence interval does not remove design limitations: a precise estimate from a single group still does not supply the missing counterfactual comparison. The registry record does not report an endpoint estimate or confidence interval, so the precision of the clinical outcome cannot be assessed.

The standard deviation and the confidence interval answer different questions. The standard deviation describes variability among individual measurements. A confidence interval describes uncertainty about an estimated quantity, such as a mean or a difference. Neither can be reconstructed responsibly from the information reported in this record. No numerical recalculation is available because the required outcome summaries are not reported.

What do the sample-size assumptions mean?

The record describes sample-size calculations as planning illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the target effect is a stated fraction of the observed effect. Such calculations are hypothetical planning exercises, not results from the enrolled study and not observed power. The listed assumptions describe a two-arm planning scenario, whereas the registered trial is single-group. Without reported observed outcome summaries, the planning illustration cannot be independently interpreted as evidence about the actual trial's clinical outcome.

In general, a sample-size calculation estimates how many participants would be needed under specified assumptions to detect a target effect with a chosen level of statistical power. Its answer depends on the target effect, outcome variability, allocation, and statistical method. If the assumed effect is smaller, planning generally calls for more information to distinguish it from random variation. This is general statistical context; the registry record does not report its own sample-size justification or enough outcome information to evaluate the assumptions against the trial's observations.

Why can over-dispersion matter?

Over-dispersion occurs when observed variability is greater than a statistical model assumes. In general, a model that understates variability can produce uncertainty estimates that are too narrow and tests that are too optimistic. The primary outcome in this record is continuous and is described using a mean and standard deviation; no model or analysis is reported, so there is no basis for claiming over-dispersion occurred or that a particular correction was used. This concept is relevant when an analysis relies on a distributional model, but it cannot substitute for the absent analysis details.

For binary safety counts, the numerator and denominator must be read together and in the context of how events were defined and collected. A count is not a comparative risk estimate when there is no control group. The registry lists serious and other adverse-event counts, but does not report event-level detail for the other adverse events or explain the collection window. The counts should therefore be treated as a limited description of what was entered in the record, not a complete characterization of safety.

More broadly, a statistical result should be interpreted in a hierarchy: identify the design, identify the outcome and analysis population, read the estimate with its uncertainty, and then assess whether the design supports the intended claim. Here, the design and outcome definition are available, but numerical clinical outcome analyses and key analysis details are not reported in the registry record. Statistical methods can explain what those missing results would mean, but cannot recover them.

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("Transcranial Magnetic Stimulation")
n   <- c(10)
m   <- c(41.8)
sp  <- c(13.2)
sd  <- sp      # posted standard deviations
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  Transcranial Magnetic Stimulation  10  41.800  13.200  32.357  51.243

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary CDRS-R outcome and two secondary outcomes: CGI-S after Treatment 30 or the last treatment, and CGI-I. When a study evaluates multiple outcomes, multiplicity is a general concern because conducting several statistical tests can increase the chance of a positive finding arising by chance. A study may address this with a prespecified testing hierarchy or another adjustment, but the registry record does not report a multiplicity strategy. It also lists no analyses, so there are no posted outcome tests to interpret.

Missing-data handling is not reported in the registry record. The primary endpoint permits the last treatment to be used for participants who withdrew early, but this description does not state how missing measurements were treated, whether all enrolled participants contributed to the endpoint analysis, or how early withdrawal affected the analysis population. The number of withdrawals and reasons for withdrawal are not reported in the registry record.

These details matter because an analysis based only on participants with recorded outcomes can differ from an analysis that accounts for missing measurements. Missingness can be related to participant characteristics or outcomes; in general, the assumptions used to handle it affect how results should be interpreted. No missing-data method, sensitivity analysis, or analysis-population definition is reported in the registry record.

The record's enrollment listing does not establish how many participants were included in any particular endpoint analysis. Although the safety counts give their own at-risk denominators, they do not define the analysis population for clinical outcomes. Without an analysis plan and outcome results, the extent to which missingness, multiplicity, or analysis-population choices affected estimates cannot be assessed.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists the Open Label Active Treatment group with 0 serious adverse events among 10 at risk and 3 other adverse events among 10 at risk. These are counts reported for the group, not comparisons against another treatment. Because the study has a single group, the figures do not estimate whether the intervention caused an event or how event counts would compare under another condition.

The record does not list any serious adverse-event terms. That should be read as an absence of listed terms in this registry entry, not as a detailed account of every event assessed or as proof that no safety concern occurred. Deaths are marked as null; death information is therefore not reported in the registry record, rather than being a stated count of zero.

The three other adverse events are not described by event type in the available registry information. The record also does not report severity, timing, duration, relatedness to treatment, or how adverse events were collected. The at-risk denominators are useful context for the posted counts, but the counts should not be expanded into percentages or compared with outside rates on the basis of this record.

In general, adverse-event counts from a small, uncontrolled study provide descriptive safety information. They cannot establish the absence of uncommon events, and they cannot provide a controlled estimate of excess risk. The registry figures should therefore be understood as limited recorded counts rather than a complete or comparative safety evaluation.

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

The registry record establishes that a completed, open-label, single-group study of rTMS in depressed adolescents was registered, with enrollment listed as 10. It identifies the CDRS-R after Treatment 30 or the last treatment for early withdrawals as the primary outcome, and lists CGI-S and CGI-I as secondary outcomes. It also records adverse-event counts for the active-treatment group. These are informative features of the study record, but they are not a numerical report of clinical efficacy.

The primary outcome result is not reported in the registry record. There is no posted mean, standard deviation, change estimate, or confidence interval to show the observed score or its precision. Thus, the information available does not indicate whether CDRS-R scores changed, by how much they changed, or how uncertain any estimate might be. The secondary outcomes likewise have no reported numerical analyses.

Even if a within-group change were available, the single-group design would limit causal interpretation. Without a concurrent comparator, the study cannot directly determine how outcomes would have differed without rTMS or under another intervention. Open-label conduct is another design feature relevant to interpretation, particularly for clinician-rated outcomes. These considerations describe what the design can and cannot establish; they do not show that a specific bias occurred.

The safety counts are descriptive and do not establish comparative risk. The registry reports 0 serious adverse events and 3 other adverse events in the active-treatment group, each with 10 at risk. Event descriptions are limited, and death information is not reported in the registry record. Those entries cannot be taken as a complete account of all possible harms.

Accordingly, the record supports a careful account of the study's design, measurement, and posted safety counts. It does not support a conclusion that rTMS did or did not change depressive symptoms, nor a precise estimate of any such change. Distinguishing an outcome definition from an outcome result is essential: the former is registered, while the latter is not reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically notable because its design and outcome definition are visible while its numerical outcome analyses are not. That distinction is important in clinical research: registration information can clarify what investigators intended to measure, but intention is not evidence about what the measurements showed. Here, the CDRS-R is clearly identified as the primary measure, yet no numerical primary result is reported in the registry record.

The single-group structure also makes the limits of causal interpretation particularly clear. An observed change over time, if available, would describe the group rather than isolate what was caused by treatment. A concurrent randomized comparison can help address differences that would otherwise be difficult to separate from treatment effects; this record does not describe that design. This is a general methodological point, not an inference about the outcomes of these participants.

The endpoint timing has an additional interpretive feature: the primary outcome is specified after Treatment 30 or at the last treatment for early withdrawals. This accommodates a measurement at withdrawal, but it also makes analysis details important. The registry does not report the number of early withdrawals, how their endpoint measurements were handled, or which participants entered the clinical outcome analysis. Without these details, the analysis population cannot be reconstructed.

The safety entries illustrate why event counts require context. The record gives counts and at-risk denominators, but does not provide a control group or descriptions for the other adverse events. These figures are useful as a limited registry account and should not be mistaken for a comprehensive or comparative safety analysis.

Finally, the sample-size assumptions are described as planning illustrations rather than the trial's own design justification. This distinction prevents hypothetical planning calculations from being confused with observed evidence or observed power. Taken together, the record is useful for understanding the registered study's structure and measurement choices, while also showing why transparent outcome analyses and analysis details are necessary for statistical interpretation.

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 most direct limitation for interpreting this trial is that the registry record lists no analyses and does not report numerical results for the primary or secondary outcomes. Without observed outcome summaries, the magnitude, direction, and precision of any clinical outcome cannot be assessed. The registered endpoint definition cannot stand in for a reported result.

The single-group, open-label design limits what a result could establish even if a within-group estimate were available. There is no concurrent comparator to distinguish treatment-associated change from other changes over time, and the record does not describe masking. Whether outcome assessors were blinded is not reported in the registry record. These are design constraints, not evidence that the measurements were necessarily biased.

Important details about participant flow and outcome analysis are also absent. The registry does not report the number of early withdrawals, their reasons, the number included in each clinical analysis, or the method used for missing observations. The primary endpoint allows measurement at the last treatment for early withdrawals, but does not explain how those measurements were incorporated into an analysis.

The intervention description is incomplete in the registry entry: it ends while describing the total number of trains. Other details about treatment delivery and adherence are not reported in the registry record. Eligibility criteria, baseline characteristics, and the sample-size justification are also not reported. These omissions limit assessment of who was studied, how fully the intervention was delivered, and how the planned enrollment related to the intended statistical question.

Safety information is limited to grouped counts and at-risk denominators. Detailed descriptions of the three other adverse events, event timing, severity, relatedness, and the method of collection are not reported. The registry does not provide serious-event terms, and death information is not reported. These omissions prevent a broad safety interpretation from the listed counts alone.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Depressed Teens — NCT01502033.
• Registry record last updated 2016-04-22; status last verified 2016-04.
• Results first posted 2016-02-17.
• 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

NCT01502033 is a completed, open-label, single-group study of repetitive transcranial magnetic stimulation in depressed adolescents with Major Depressive Disorder. Enrollment is listed as 10. The primary outcome is the CDRS-R after Treatment 30 or the last treatment for early withdrawals; CGI-S and CGI-I are listed as secondary outcomes.

The intervention description specifies 30 daily treatments and several rTMS settings, but its final treatment detail is incomplete. No clinical outcome analyses or numerical results are reported in the registry record. The active-treatment group lists 0 serious adverse events and 3 other adverse events, with 10 at risk for each category; death information is not reported. The single-group design does not provide a concurrent control comparison.