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 Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture (NCT02579343), a randomized na study. The primary outcome is Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02579343 |
| Phase | NA |
| Condition | Major Depressive Disorder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 13 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Florida Gulf Coast University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned college students with major depressive disorder. The registry record lists the condition but does not give further eligibility criteria or describe the participants’ baseline characteristics.
Intervention
Participants received Lexapro, described as 10 mg daily with an increase to 20 mg daily at week 2, along with auricular acupuncture delivered twice weekly using micro-currents of electricity.
Comparator
The comparison group received the same stated Lexapro schedule and twice-weekly sham auricular acupuncture without micro-current. This comparison focuses on adding active electrical stimulation within the treatment regimen described.
Primary question
The primary outcome was change from baseline in Sheehan Disability Scale score through 6 weeks. The registry record does not report a numerical between-group estimate for this outcome, so it does not establish the direction or size of any difference between the study groups.
The research question is whether adding auricular acupuncture with micro-currents to the stated Lexapro regimen is associated with a different change in functional impairment than adding sham auricular acupuncture with that regimen. Because both groups received Lexapro, the intended comparison is not acupuncture versus no treatment, nor is it Lexapro versus acupuncture. It is a comparison of the two adjunctive acupuncture procedures in the setting of the shared medication schedule.
The study is listed as randomized and single blind, with a parallel-group model and a 6-week duration. The registry record does not identify who was blinded or provide a numerical primary-outcome result. Those omissions limit interpretation of both the comparison and its statistical strength.
3. Trial Design
The registry describes a randomized, single-blind, parallel-group study with a 6-week duration. Enrollment is recorded as 13. The study status is completed, and the record lists a start of 2015-08 and primary completion of 2016-05. The record does not give further details about the conduct of randomization, such as how the sequence was generated or concealed.
Participants in the active acupuncture group received Lexapro 10 mg daily, increased to 20 mg daily at week 2, and twice-weekly auricular acupuncture with micro-currents. The sham group had the same stated Lexapro schedule and twice-weekly sham auricular acupuncture without micro-current. This shared medication schedule is important: the randomized contrast concerns the active versus sham acupuncture procedure as an adjunct, rather than the medication itself.
The primary outcome was change from baseline in Sheehan Disability Scale score through 6 weeks, assessed at baseline and 6 weeks. The registry lists two outcome measures and two analyses, but does not report the analysis details or numerical primary-outcome results. The primary outcome is flagged as having several categories or time points and is not reduced to one comparison in the registry record.
The record labels the phase as not applicable. It does not report the masking target, eligibility criteria, allocation ratio, protocol deviations, participant flow, or reasons for withdrawal. The limited enrollment and short stated duration describe the scope of this trial, but do not by themselves indicate what its results were.
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: Two potential participants immediately dropped from study prior to group assignment related to scheduling and commitment concerns.
Overall Study
| Stage | Auricular Acupuncture + Lexapro | Sham Auricular Acupuncture + Lexapro |
|---|---|---|
| STARTED | 7 | 6 |
| COMPLETED | 7 | 6 |
| NOT COMPLETED | 0 | 0 |
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 | Auricular Acupuncture + Lexipro | Sham Auricular Acupuncture + Lexapro | Total |
|---|---|---|---|---|
| Participants analysed | 7 | 6 | 13 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 7 | 6 | 13 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 7 | 1 | 8 |
| Sex: Female, Male: Male | Participants | 0 | 5 | 5 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 1 | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 4 | 4 | 8 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 5 | 4 | 9 |
| Race (NIH/OMB): More than one race | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 7 | 6 | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks, measured over Assessed at baseline and 6 weeks..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in the Sheehan Disability Scale through 6 weeks. The instrument assesses functional impairment across work or school, social life, and family life. Its items use a 0 to 10 point scale, and higher scores indicate more functional impairment. The registry states that assessments were made at baseline and 6 weeks.
Functional impairment is relevant because the study concerns major depressive disorder and asks about functioning in several areas of daily life, rather than only a symptom score. Assessing change from baseline makes the endpoint a measure of how the recorded score changed over the study period. The scale’s direction is clear: higher scores indicate greater impairment. However, the registry record does not specify how a change score was signed or provide group-specific changes or a between-group estimate. Therefore, the direction and magnitude of the observed treatment contrast cannot be inferred from the endpoint description alone.
The registry record also does not report a threshold for a clinically important change, details of score completion, or a numerical estimate with a confidence interval. Without those details, the endpoint’s clinical interpretation cannot be tied to a particular observed difference. The scale description explains what was intended to be measured, but it is not itself evidence of an effect.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison and a primary functional outcome, but it does not report the numerical outcome results needed to interpret that comparison. No group means, change estimates, between-group contrast, confidence interval, or p-value for the primary outcome is reported in the record. As a result, the direction and size of the observed difference, and the precision with which it was estimated, are not reported in the registry record.
This distinction matters because an endpoint definition is not a result. The Sheehan Disability Scale measures impairment across work or school, social, and family domains, and higher scores indicate more impairment. But without the reported changes and an explicit comparison between groups, it is not possible to tell from the registry record whether either group’s score changed, whether the groups differed, or how uncertain any estimated difference may be. The scale’s direction does not substitute for the missing estimates.
The study compared auricular acupuncture with micro-currents plus Lexapro against sham auricular acupuncture plus Lexapro. Therefore, even if a difference had been reported, it would describe the contrast between those adjunctive procedures under the medication schedule stated in the record. It would not, by itself, isolate the effect of Lexapro or compare acupuncture with no adjunctive procedure.
The enrollment entry is 13, and the safety record gives group-specific numbers at risk. These registry entries help describe the study’s scale, but the record does not provide enough primary-outcome information to judge statistical evidence or estimate an effect. No conclusion about statistical significance, clinical importance, or the consistency of results across participants can be drawn from the primary-outcome information reported in the registry.
Planning illustrations use a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect defined as a stated fraction of the observed effect. Such illustrations are prospective calculations based on assumptions, not observed power and not evidence of a treatment effect. The numerical planning results and the observed effect used for them are not reported in the registry record. They cannot fill the gap left by the missing primary-outcome estimates.
The registry record’s description of the study as completed does not mean that its outcome results are fully reported there. For statistical interpretation, the key limitation is not merely that the study is small; it is that the primary comparison and its uncertainty are unavailable in the record. The record therefore supports description of the question and design, but not a quantitative conclusion about the primary endpoint.
9. Statistical Methods Explained
The registry record identifies randomization, single masking, a parallel-group model, a continuous primary measure summarized as a mean, and standard deviation as the dispersion measure. It does not report the statistical analysis plan, the method used to estimate the treatment contrast, or the numerical outcome estimates. The explanations below describe general statistical concepts; they are not claims about methods actually used in this trial unless explicitly stated in the record.
What does randomization contribute?
In general, randomization assigns participants to groups using a chance-based process. Its purpose is to reduce systematic differences between groups at the point of assignment, including differences that might otherwise influence outcomes. Randomization does not guarantee that groups will be alike in every characteristic, especially in a small study. The registry record confirms that the study was randomized, but does not report the sequence-generation method, allocation concealment, or checks on how randomization was implemented. Those details are not reported in the registry record.
In this trial, both groups were assigned a Lexapro schedule, while the acupuncture procedure differed: active treatment used micro-currents and sham treatment did not. General interpretation of a randomized comparison should keep that contrast in view. The comparison concerns the assigned adjunctive procedures in the context of the shared medication regimen, rather than an unconfounded comparison of all components of care.
What do a mean and standard deviation describe?
In general, a mean describes the central value of a set of measurements, while a standard deviation describes how spread out individual measurements are around that mean. The mean is useful for summarizing a continuous outcome such as a scale score. The standard deviation describes variation among individual observations; it is not the same as the uncertainty in a group mean or in a between-group treatment estimate.
For a randomized treatment comparison, the central statistical quantity is often a contrast between groups, such as a difference in mean change. The registry record does not report such an estimate for the primary outcome. It also does not report group means or standard deviations for the endpoint. Consequently, none of these quantities can be interpreted from the registry record, even though the measure is identified as continuous and the intended summary parameters are named.
Why does a confidence interval matter?
In general, a confidence interval describes the range of values compatible with the data and the statistical procedure used, under its assumptions. It communicates the precision of an estimate: a narrower interval indicates greater precision, and a wider interval indicates greater uncertainty. A confidence interval also helps readers judge whether the data are compatible with effects of different sizes and directions. No confidence interval for the primary comparison is reported in the registry record, so the precision of that comparison is unknown.
A p-value addresses a different question. In general, it measures how incompatible the observed data are with a specified null hypothesis under the analysis assumptions. It does not state the probability that the null hypothesis is true, nor does it measure clinical importance. No primary-outcome p-value is reported in the registry record. Without both an effect estimate and a measure of uncertainty, the statistical evidence cannot be characterized from this record.
What does the planning illustration mean?
In general, a sample-size calculation asks how much information a future study might need to detect a prespecified effect under stated assumptions. The registry’s planning assumptions specify a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. These assumptions describe planning illustrations, not the original trial’s design rationale. The sample-size justification for the trial is not reported in the registry record.
Planning calculations based on an observed effect are sensitive to that effect estimate. In general, an estimate from a small study can be uncertain, so a planning illustration using it should not be treated as a dependable forecast of the result of a future study. Nor is a sample-size calculation an observed-power analysis. The numerical planning outputs and the observed effect used in those calculations are not reported in the registry record, so no planning value can be interpreted.
What is not established about the analysis?
The record lists two outcome measures and two analyses, but does not describe which statistical tests or models were used, whether the analysis adjusted for baseline score, or how repeated assessments or any categories were handled. It does not report assumptions checks, handling of outliers, or a prespecified primary analysis population. These methods are not reported in the registry record. General statistical explanations should therefore not be mistaken for a reconstruction of the investigators’ analysis.
Likewise, no information is reported about whether analyses were adjusted for other variables, whether an interim analysis occurred, or whether the analysis plan changed. The primary outcome is identified as involving several categories or time points and is not reduced to one comparison in the registry record. Without those details and without the numerical estimate, readers cannot verify how the stated endpoint relates to the analyses or assess the robustness of a particular result.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists two outcome measures and two analyses, but does not describe how the primary and other outcomes were prioritized or how multiple statistical comparisons were handled. It does not report a multiplicity adjustment, a testing hierarchy, or an explanation of whether any adjustment was considered. These matters are not reported in the registry record. In general, when multiple hypotheses are tested, the chance of at least one apparently unusual result can increase; a prespecified strategy helps readers understand how evidence across tests was interpreted. That general concern cannot establish which strategy, if any, was used in this study.
The primary outcome is described as change in Sheehan Disability Scale score through 6 weeks, assessed at baseline and 6 weeks. The registry record also flags the primary outcome as having several categories or time points and does not reduce it to one comparison. It does not explain which category or time-point comparison was considered primary for statistical testing. This leaves the precise inferential target unclear in the registry record.
Missing-data methods and the amount or pattern of missing outcome data are not reported in the registry record. There is no reported description of withdrawals, incomplete scale responses, imputation, or sensitivity analyses. The record also does not state whether the analysis included all randomized participants, only participants with observed endpoint data, or another analysis population. Those details are not reported in the registry record, so it is not possible to assess how missingness may have affected the endpoint estimates.
The registry status is completed, but this does not supply the missing analysis details. Without information about multiplicity, missing data, and analysis populations, readers cannot determine how those choices may have shaped the statistical conclusions. These gaps are separate from the absence of numerical primary-outcome results and further limit independent interpretation.
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 |
|---|---|---|---|
| Auricular Acupuncture + Lexipro | 0 | 7 | 0.0% |
| Sham Auricular Acupuncture + Lexapro | 0 | 6 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Auricular Acupuncture + Lexipro | 0 of 7 |
| Sham Auricular Acupuncture + Lexapro | 0 of 6 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Auricular Acupuncture + Lexipro | 0 of 7 |
| Sham Auricular Acupuncture + Lexapro | 0 of 6 |
The safety record reports zero serious adverse events in the auricular acupuncture plus Lexapro group among 7 participants at risk, and zero in the sham auricular acupuncture plus Lexapro group among 6 participants at risk. It also reports zero other adverse events in each group and zero deaths in each group. No serious adverse event terms are listed.
These entries describe what the registry reports for the groups and outcomes it records. In general, observing zero events does not establish that an event cannot occur or precisely quantify its frequency. The amount of information depends in part on the number of participants observed and the completeness and duration of safety follow-up. The registry record does not provide further detail about adverse-event collection, definitions, follow-up completeness, or how events were attributed.
The safety figures should therefore be read as recorded event counts, not as proof that either regimen is free of risk. They also do not establish a comparative safety advantage. The record’s stated follow-up period for the study was 6 weeks, and the safety information should not be taken to describe outcomes beyond what the registry reports.
12. What the Result Does, and Does Not, Mean
The registry record establishes the study question and the intended randomized contrast: active auricular acupuncture with micro-currents plus Lexapro versus sham auricular acupuncture without micro-current plus Lexapro. It also identifies change in Sheehan Disability Scale score through 6 weeks as the primary endpoint. These details allow readers to understand what comparison was planned and what functional outcome was intended to be measured.
The record does not report the numerical primary-outcome results. It therefore does not show whether the groups had different mean changes, what direction any difference took, how large it was, or how precisely it was estimated. The endpoint definition and the fact that the trial is marked completed cannot answer those questions. No conclusion about statistical significance or the practical importance of a difference can be drawn from the registry record.
Even with complete numerical results, the interpretation would be limited to the studied comparison and context. The groups shared the stated Lexapro schedule, and differed in active versus sham auricular acupuncture. A comparison of those groups would not, by itself, answer whether Lexapro is effective, whether acupuncture works without medication, or how either approach compares with no treatment. The record also does not report enough information about eligibility or participant characteristics to determine how broadly the findings might apply.
The safety entries report no serious adverse events, other adverse events, or deaths in the recorded groups. These counts do not prove the absence of risk, and the record gives no further information about safety ascertainment. Overall, the registry supports a description of the design and recorded safety counts, but it does not provide the primary-outcome evidence needed to characterize the treatment effect.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a registered research question and a reportable result. The record identifies randomization, the two adjunctive procedures, a shared medication schedule, and a functional primary endpoint. Yet the numerical primary-outcome comparison is not reported in the registry record. A defined endpoint alone cannot show the size, direction, or precision of an effect.
The treatment contrast also matters for interpretation. Because both groups received Lexapro, the comparison was designed around active versus sham auricular acupuncture within that treatment context. Keeping the contrast explicit prevents attributing a hypothetical group difference to a component that was shared by both arms. The record does not report enough outcome data to evaluate even that narrower contrast.
The registry’s safety entries illustrate another statistical point: zero recorded events are counts, not proof of no risk. Interpretation depends on what was observed, how it was collected, and how much information the study provides. The record gives group-specific at-risk counts and event counts, but not detailed safety methods.
Finally, the record lists multiple outcomes and analyses and flags the primary outcome as involving several categories or time points, while leaving the analysis choices and multiplicity handling undescribed. Such omissions make it harder to understand which comparison was intended to carry the main inferential weight. The trial therefore highlights why complete outcome estimates, uncertainty measures, and analysis details are essential for readers to evaluate clinical research statistically.
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.
The most direct limitation for interpretation is that numerical results for the primary endpoint are not reported in the registry record. Without group-specific changes, a between-group estimate, and a measure of uncertainty, the primary question cannot be answered quantitatively from this record. The endpoint is also flagged as involving several categories or time points without a single comparison being reported.
Enrollment is recorded as 13, and the study lasted 6 weeks. These registry entries indicate a limited study scope, but the registry record does not provide a sample-size justification, so it is not possible to determine the intended precision or detectable effect. The planning assumptions described in the record do not establish that the trial was designed around a particular effect or that any observed result would be conclusive.
Important design and analysis details are absent. The record does not report who was blinded, how randomization was implemented, the eligibility criteria, participant characteristics, participant flow, withdrawals, missing-data handling, analysis populations, statistical tests, or multiplicity procedures. It does not report whether an interim analysis occurred or whether the statistical plan changed. These omissions prevent a detailed assessment of risk of bias and analytical choices.
The study compares active and sham acupuncture as adjuncts to the same stated Lexapro regimen. It therefore cannot be interpreted from its design description as a comparison of Lexapro with no medication or acupuncture with no adjunctive treatment. The registry record also provides no detailed safety-collection methods, limiting interpretation of the recorded adverse-event counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture — NCT02579343.
- Registry record last updated 2021-10-12; status last verified 2021-09.
- Results first posted 2021-10-12.
- 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.
18. Record Summary
The registry describes a completed, randomized, single-blind, parallel-group study of auricular acupuncture as an adjunctive treatment for major depressive disorder in college students. Enrollment is recorded as 13, and the study duration is 6 weeks. One group received Lexapro with active auricular acupuncture using micro-currents; the other received the stated Lexapro schedule with sham auricular acupuncture without micro-current.
The primary endpoint was change from baseline in Sheehan Disability Scale score through 6 weeks. The scale assesses impairment in work or school, social life, and family life, with higher scores indicating more impairment. Numerical primary-outcome results and the analysis details are not reported in the registry record. Safety entries report zero serious adverse events, zero other adverse events, and zero deaths in each group.