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 A Pilot Study Assessing EmSam in Bipolar Depression (NCT00535262), a na phase 4 study. The primary outcome is Reduction of Depression CGI Score (<= 2).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00535262 |
| Phase | Phase 4 |
| Condition | Bipolar Depression |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 3 |
| Arms in the primary outcome | n/a |
| Lead sponsor | New York State Psychiatric Institute |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with bipolar depression. The registry lists enrollment as 3. It does not provide further characteristics of the participants in the record, so the population cannot be described more specifically.
Intervention
The intervention was EmSam, described as a selegiline transdermal system and a monoamine oxidase inhibitor. The arm description says it was to be administered open-label for 8-weeks, with symptoms assessed weekly. Responders after 8-weeks were to enter an 8-month open-label continuation phase; the continuation description is incomplete in the registry record.
Comparator
There was no separate comparator group in the recorded design. Allocation is listed as NA, masking as NONE, and the model as SINGLE GROUP. The findings therefore cannot be read as a like-for-like comparison between EmSam and another treatment or a control condition.
Primary question
The primary outcome is titled “Reduction of Depression CGI Score (<= 2)” and has a timeframe of 8 weeks. The record’s outcome description refers to HAM-D and several other measures, but reports that 0 participants were analyzed due to early termination. It therefore does not answer the primary question with an observed efficacy estimate.
3. Trial Design
This was a Phase 4, single-group study of EmSam for bipolar depression. The registry lists the study as open-label, with masking recorded as NONE and allocation recorded as NA. Those design features mean that the posted record does not describe a randomized, blinded comparison. Its planned treatment exposure was not the same as a head-to-head test against a control arm.
The arm description says EmSam would be given open-label for 8-weeks during phase I, with depression symptoms assessed weekly. Participants whose depression responded after 8-weeks were to enter an 8-month open-label continuation phase. The continuation description ends with “maintained on Em”; what would follow that text is not reported in the registry record. These details describe the intended schedule, not evidence that participants completed it.
The registry lists enrollment as 3 and the study status as TERMINATED. Its primary outcome description explicitly says that 0 participants were analyzed due to early termination. The record lists a start date of 2007-03 and a primary completion date of 2012-02. Those registry dates do not establish how long any participant received treatment.
There is a single-group intervention listing, not a like-for-like control comparison. The trial is classified as kind “other,” and the record lists 1 outcome measure and 0 analyses. A sample-size calculation based on a treatment comparison is not an account of the study’s actual design. Details such as the reason for termination, the intended sample-size justification, and the statistical analysis plan 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: Hypomania/mania requires treatment with mood stabilizer for at least two weeks; must be anti-depressant-free for two weeks (six weeks for fluoxetine.
Overall Study
| Stage | EmSam |
|---|---|
| STARTED | 3 |
| COMPLETED | 0 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | EmSam |
|---|---|
| No funding | 3 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Seeking pilot data
| Characteristic | Unit | Open EmSam |
|---|---|---|
| Participants analysed | 3 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 3 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 2 |
| Region of Enrollment: United States | participants | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Reduction of Depression CGI Score (<= 2), measured over 8 weeks.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is titled “Reduction of Depression CGI Score (<= 2)” and gives an 8 weeks timeframe. The title suggests a threshold-based outcome involving a depression CGI score, but the registry record does not define the CGI scale, explain how the threshold was to be applied, or specify whether the intended analysis concerned a proportion of participants or a change in scores.
The outcome description lists “HAM-D score” and also names the Young Mania Scale, Life Chart Method, Patient Global Impression, Symptom Checklist - 90, and Quality of Life Enjoyment and Satisfaction Questionnaire. It does not clarify how those measures relate to the titled primary outcome or which were intended as primary versus supporting measures. That relationship is not reported in the registry record.
Clinical scales can be used to describe symptoms or functioning in a structured way. General statistical context: a clearly defined endpoint helps readers understand what quantity an analysis estimates and when it is measured. Here, however, no endpoint values or participant-level results are posted. The record states that 0 participants were analyzed due to early termination, so there is no observed primary-outcome estimate to interpret. The outcome title and planned timeframe identify the question the study set out to assess, not a reported result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is that the registry reports 0 participants analyzed for the primary outcome because of early termination. Consequently, the posted record does not provide an estimate of depression-score reduction, a response rate, or an uncertainty interval for the primary endpoint. It cannot establish the magnitude or precision of an effect in this study.
The record lists enrollment as 3, but enrollment is not interchangeable with the number analyzed for an endpoint. The outcome description explicitly identifies the analyzed count as 0. This distinction matters: readers should not treat enrollment as if it were the denominator for a treatment response calculation, and no such calculation is supported by the posted result.
The design also limits what a result could have established. This is a single-group, open-label study with allocation recorded as NA and masking as NONE. There is no separate control group in the record. General statistical context: without a concurrent comparator, changes observed during treatment cannot be separated cleanly from other influences, such as the course of symptoms over time, expectations, or other aspects of care. This is a design limitation, not a claim about what happened to these participants.
There is no inferential analysis reported: the record lists 0 analyses. It gives no treatment-effect estimate, standard error, confidence interval, or p-value for the primary outcome. Such quantities are therefore not available to assess statistical uncertainty. General statistical context: a confidence interval expresses a range of estimates compatible with the data and model used; it does not replace the need for an analyzable outcome or an appropriate comparison. Here, the record supplies neither a primary-outcome analysis nor a comparison from which to draw a treatment contrast.
The safety entries list 3 at risk and 0 affected for both serious and other adverse events in the EmSam group. These are descriptive counts. The record does not provide event terms for serious events, and deaths are listed as null rather than as a numerical count. The small posted at-risk group and the absence of analyzed efficacy outcomes mean the safety entries cannot fill the gap in the primary efficacy result.
The sample-size section on the page is a planning illustration based on an observed effect, not the study’s own design. Because the registry record reports no analyzed primary outcome and no observed effect estimate, that type of illustration should not be mistaken for a result from this trial or for observed power. The tables and plots should be read in light of these boundaries: the registry record does not furnish an analyzed treatment effect for this study.
9. Statistical Methods Explained
The registry record identifies a single-group, open-label Phase 4 study. It does not report a statistical analysis plan, an inferential method, or a model used to analyze the primary outcome. The discussion below explains general statistical ideas that help interpret the record; it does not attribute an unreported method to this trial.
What does a single-group design estimate?
A single-group study can describe what was observed among participants who received the intervention, if outcomes are collected and analyzed. Without a separate comparison group, it cannot directly estimate a treatment contrast against another intervention or control condition. General statistical context: an observed change over time may have several possible explanations, and a study without a concurrent comparator cannot separate those explanations as a randomized comparison is designed to do.
Here, even a descriptive primary-outcome estimate is unavailable: the record says 0 participants were analyzed because of early termination. The record therefore does not provide a mean change, a count meeting the titled threshold, or another summary of the primary endpoint. Those quantities should not be reconstructed from enrollment or adverse-event entries.
What do masking and allocation tell us?
Masking is recorded as NONE, allocation as NA, and the model as SINGLE GROUP. In general, masking refers to whether participants or study personnel are kept unaware of an assigned intervention, while allocation describes how participants are assigned across study groups. These entries are consistent with the registry’s single-group description, but the record does not describe any assignment process or separate comparator arm. There is consequently no randomized between-group estimate in the posted results.
Open-label measurement can also be relevant when outcomes involve clinical ratings or participant reports. General statistical context: knowledge of treatment may influence expectations or assessments. This is a general concern associated with open-label designs; the registry record does not show whether or how such influence affected this study.
What can an estimate and its uncertainty show?
In an analyzed study, a treatment-effect estimate summarizes the observed quantity of interest, while a standard error or confidence interval describes uncertainty under specified assumptions. A p-value, when reported, measures compatibility between data and a null model under the chosen analysis; it is not a measure of clinical importance. These are general explanations, not methods reported for this trial.
For this record, no primary-outcome estimate, uncertainty interval, or p-value is posted. With 0 participants analyzed for the endpoint, there is no outcome estimate around which to describe statistical precision. The study’s enrollment entry does not change that fact. A small analyzed group would ordinarily yield limited precision, but the relevant primary-outcome analyzed count is explicitly 0, so even that kind of estimate is absent.
Why are planning illustrations different from results?
Sample-size calculations are commonly used in planning to ask how many participants might be needed under assumptions about the effect to detect, the variability, the significance level, and the allocation. General statistical context: the answer depends on those assumptions and on the analysis design. A planning illustration based on an observed effect is not the same as a calculation documented in the trial protocol, and it does not report what the trial observed.
The page includes planning illustrations, but the registry record does not report its own sample-size justification or analysis assumptions. The illustrations should therefore be read as hypothetical planning scenarios, not as a description of the study’s intended design or a measure of achieved power. Power is a design concept tied to assumed effects and analysis conditions; it is not evidence that a treatment effect was observed.
What do the safety counts contribute?
The registry lists 3 participants at risk for serious adverse events and 0 affected in the EmSam group. It separately lists 3 at risk for other adverse events and 0 affected. These are event-summary fields, not an efficacy analysis. General statistical context: a count of zero observed events does not establish that an event is impossible or that risk is absent, particularly when the amount of observation is limited. The record does not supply enough detail to characterize follow-up or event ascertainment further.
Deaths are recorded as null. Null is not a numerical count and should not be interpreted as a report of zero deaths. The record does not give a death count in this field. Taken together, the design, absence of primary-outcome analysis, and limited safety summaries place clear boundaries on statistical interpretation. No unreported test, model, adjustment, or missing-data procedure should be assumed.
10. Multiplicity, Missing Data and Analysis Populations
The outcome description names several clinical measures: HAM-D score, Young Mania Scale, Life Chart Method, Patient Global Impression, Symptom Checklist - 90, and Quality of Life Enjoyment and Satisfaction Questionnaire. The primary outcome title refers to a Reduction of Depression CGI Score (<= 2), but the record does not explain how the listed measures relate to that titled outcome. It does not identify a hierarchy of endpoints, state which measures were secondary, or describe a multiplicity adjustment. These details are not reported in the registry record.
General statistical context: when multiple outcomes or analyses are examined, the chance of finding an apparently notable result can depend on how many tests are considered and how results are selected or adjusted. That concept does not establish that multiplicity affected this study. The registry lists 1 outcome measure and 0 analyses, and no outcome analysis is posted. There is no reported set of tests from which to assess adjustment or selective reporting.
The primary outcome description states that 0 participants were analyzed due to early termination. The record does not explain participant-level missingness, whether outcome assessments were collected, or how missing values would have been handled. It does not report an analysis population, exclusions, imputation procedure, or sensitivity analysis. These items are not reported in the registry record.
General statistical context: missing-data methods rely on assumptions about why measurements are unavailable. Without a description of missingness and the analysis population, readers cannot evaluate such assumptions. In this case, the record’s reported reason for the absence of an analysis is early termination; it does not give more detail about the status of individual outcome data.
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 |
|---|---|---|---|
| EmSam | 0 | 3 | 0.0% |
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 |
|---|---|
| EmSam | 0 of 3 |
The EmSam safety entries list 3 participants at risk for serious adverse events and 0 affected. For other adverse events, the record also lists 3 at risk and 0 affected. These entries describe what is posted in the registry; they do not replace the absent primary efficacy analysis.
The serious-event list contains no terms. The record therefore does not describe particular serious adverse events. The deaths field is null, not a numerical zero, so the record does not report a death count in that field. It would be inaccurate to restate null as “no deaths.”
General statistical context: an observed count of 0 is not proof that an event cannot occur. Safety summaries are most informative when readers can also assess the number followed, the duration and completeness of observation, and how events were collected. The registry record does not report those details. It also does not support a comparison of safety between treatments, because it describes a single-group study without a separate comparator.
These counts should be read narrowly as registry summaries for the listed group. They do not establish the absence of risk, and they should not be used to infer details about events or follow-up that are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The posted record documents a pilot study of EmSam for bipolar depression and describes an intended open-label treatment period followed by a continuation phase for responders. It also records enrollment as 3 and gives a study status of TERMINATED. Most importantly for efficacy interpretation, the primary outcome description says 0 participants were analyzed due to early termination.
As a result, this record does not show an analyzed response or symptom change, and it does not give a numerical estimate of treatment effect. It contains no reported confidence interval or p-value for the primary outcome. Readers cannot judge the size or precision of an efficacy result from these entries, because the primary endpoint was not analyzed in the posted record.
The record also does not establish how EmSam compares with another treatment or with a control condition. The design is single-group and open-label, with allocation listed as NA and masking as NONE. General statistical context: comparison groups help distinguish differences associated with treatment assignment from changes that may occur for other reasons. No such comparison is reported.
The adverse-event fields show 0 affected among 3 at risk for both serious and other adverse events. Those entries are descriptive and do not prove that risks are absent. The deaths field is null, which does not provide a numerical count. Nor do the safety entries supply an efficacy result.
The intended schedule and the measured outcome names help explain what the investigators set out to study, but they should not be confused with completed treatment exposure or observed outcomes. The continuation-phase description is incomplete, and the registry does not explain the reason for termination or provide details on individual outcome data. The sample-size illustrations elsewhere on the page are planning scenarios, not results from this trial. Overall, this is a record of a small, terminated pilot with no analyzed primary outcome; it does not support a conclusion about efficacy or comparative effectiveness.
13. Why This Trial Matters Statistically
This trial is statistically instructive because its registry record separates a study’s intended question from the evidence actually available to answer it. The title and outcome description indicate an interest in depression symptoms after 8 weeks, and the arm description outlines open-label treatment. But the primary outcome entry says 0 participants were analyzed due to early termination. A stated research question is not itself an estimate of an effect.
The record also illustrates why enrollment and analysis counts must not be treated as interchangeable. Enrollment is listed as 3, while the primary outcome entry reports 0 analyzed. That distinction is central to interpreting any trial report: the denominator for an outcome analysis must come from the analyzed data, not from a general enrollment field. Here, the posted record does not supply an analyzed efficacy denominator or outcome values.
The design is another important lesson. A single-group, open-label study can provide descriptive observations when outcomes are available, but it cannot make a randomized comparison with a control group. Readers should distinguish a planned treatment experience from evidence that attributes a change to treatment. In this record, no primary efficacy analysis is available even for a descriptive estimate.
Finally, the entries demonstrate how to read missing and null values carefully. The serious and other adverse-event fields report zero affected among the listed at-risk group, while the deaths field is null. Zero is a reported count; null is not a numerical count. Keeping those categories separate prevents a record from appearing more complete than it is.
For statistical readers, the case underscores the value of transparent reporting of endpoint definitions, analysis populations, missing data, and reasons for discontinuation. Several such details are not reported in the registry record. The result is not a negative efficacy finding; it is an absence of an analyzed primary outcome in the posted record.
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.
This record has substantial limits for interpreting efficacy. It reports 0 participants analyzed for the primary outcome due to early termination, so there is no posted primary-outcome estimate. The record lists enrollment as 3, but does not provide individual outcome values or explain the status of outcome collection beyond the stated reason for having no analysis.
The single-group, open-label design has no separate comparator. Allocation is recorded as NA and masking as NONE, so the record does not support a direct treatment comparison. Even if outcome data had been analyzed, the design would not by itself distinguish treatment-associated change from other influences as a controlled comparison can.
The outcome information is also incomplete for interpretation. The primary title refers to a CGI score threshold, while the description lists HAM-D and other measures without explaining their relationship to the primary outcome. The registry record does not report a detailed endpoint definition, a statistical analysis plan, an analysis population, missing-data procedures, multiplicity handling, or a sample-size justification. The reason for termination is not reported in the registry record.
Follow-up and safety reporting have limits as well. The continuation-phase description is truncated, the serious adverse-event terms are not listed, and the deaths field is null rather than a count. The registry does not provide details of event ascertainment or duration of observation. These gaps mean the posted safety counts should be interpreted only as the listed summaries, not as comprehensive evidence about risk.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Pilot Study Assessing EmSam in Bipolar Depression — NCT00535262.
- Registry record last updated 2014-10-28; status last verified 2013-05.
- Results first posted 2014-10-28.
- 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 record describes NCT00535262, “A Pilot Study Assessing EmSam in Bipolar Depression,” as a Phase 4, open-label, single-group study of EmSam for bipolar depression. Allocation is listed as NA, masking as NONE, enrollment as 3, and status as TERMINATED. The record gives a start date of 2007-03 and a primary completion date of 2012-02.
The primary outcome is titled “Reduction of Depression CGI Score (<= 2)” with a timeframe of 8 weeks. Its description lists several clinical measures and states that 0 participants were analyzed due to early termination. The record lists 1 outcome measure and 0 analyses. It does not provide a primary efficacy estimate.
For the EmSam group, the registry lists 3 at risk and 0 affected for serious adverse events, and 3 at risk and 0 affected for other adverse events. The deaths field is null. The record does not report a comparator group, a statistical analysis plan, or the reason for termination.