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 Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression (NCT02285504), a na phase 2 study. The primary outcome is Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02285504 |
| Phase | Phase 2 |
| Condition | Postpartum Depression |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 4 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Supernus Pharmaceuticals, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Adult female participants diagnosed with severe postpartum depression were eligible for the study. The registry lists postpartum depression as the condition and records an enrollment of 4. The safety population included participants who began the SAGE-547 infusion. The registry record does not report further eligibility details in the information available for this analysis.
Intervention
The intervention was SAGE-547, administered by intravenous infusion. The arm description states that the infusion was over 60 hours, including a 12-hour titration infusion. The registry describes the study as evaluating safety, tolerability, pharmacokinetics, and efficacy. The full dosing description is not reported in the registry record available for this analysis.
Comparator
There was no separate control group. The registry identifies a single-group model, allocation as not applicable, and no masking. Consequently, the study does not compare SAGE-547 with placebo, usual care, or another treatment. The absence of a comparator is central when interpreting both safety observations and any changes in depression scores.
Primary question
The primary endpoint counts participants with treatment-emergent adverse events and treatment-emergent serious adverse events. The registry reports that 4 participants had a treatment-emergent adverse event and 0 had a treatment-emergent serious adverse event. These are descriptive counts in the study group. They do not establish how those outcomes would compare with outcomes under a different treatment or without SAGE-547.
3. Trial Design
This was a Phase 2, open-label, proof-of-concept study of SAGE-547 in adult female participants with severe postpartum depression. The registry records the study as completed, with a start date of 2015-01-07 and a primary completion date of 2015-06-05. Enrollment was 4. It was a single-group study, with allocation listed as not applicable and masking listed as none. Thus, participants were not assigned across randomized treatment arms, and there was no blinded comparison.
Participants received SAGE-547 by intravenous infusion. The arm description specifies an infusion over 60 hours and describes a 12-hour titration period. The study’s stated aims included safety, tolerability, pharmacokinetics, and efficacy. The registry lists pharmacokinetic outcomes such as maximum plasma concentration, time to maximum concentration, and measures of drug exposure and clearance. It also lists change from baseline in the Hamilton Rating Scale for Depression-17 total score as a secondary outcome.
The primary endpoint concerns counts of participants with treatment-emergent adverse events and treatment-emergent serious adverse events. Its event windows extend to Day 11 for treatment-emergent adverse events and Day 34 for treatment-emergent serious adverse events. The registry defines the safety population as all participants who began the infusion.
The design can describe events and measurements observed among participants receiving the study intervention. It cannot, by itself, separate changes associated with treatment from changes that might have occurred over time, from other care, or from other influences. A protocol rationale for the enrollment target and a detailed 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: A total of 6 participants were screened, 4 participants were treated and completed the study. This study consisted of up to a 3-day screening period, a 4-day (84-hour) active treatment period, a 7-day adverse event (AE) follow-up period, plus an additional 23 days of serious AE follow-up (with a telephone call at Day 11 and Day 34).
Overall Study
| Stage | SAGE-547 |
|---|---|
| STARTED | 4 |
| COMPLETED | 4 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety population included all participants who began infusion with SAGE-547 injection.
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: Safety population included all participants who began infusion with SAGE-547 injection.
| Characteristic | Unit | SAGE-547 |
|---|---|---|
| Participants analysed | 4 | |
| Age, Continuous | years | 32.0 (SD 6.88) |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 4 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), measured over TEAEs: Up to Day 11, TESAEs: Up to Day 34.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs). An adverse event was any untoward medical occurrence in a participant who received study treatment, regardless of whether it was considered causally related to treatment. A TEAE was defined as an event beginning after the SAGE-547 infusion started, or a worsening of a pre-existing medical condition, within the stated window extending to Day 11. A TESAE used the corresponding definition with a window extending to Day 34.
Counting participants is useful for a safety endpoint because it records how many people experienced at least one event of the specified type, rather than how many episodes occurred. The registry reports 4 participants with TEAEs and 0 participants with TESAEs. These are counts for the study group, not comparisons with a control group. They also do not communicate event severity beyond the distinction between the registry’s adverse-event and serious-adverse-event categories, nor do they describe the specific events in detail.
The endpoint is appropriate to a study whose stated aims include evaluating safety, but interpretation depends on the size and design of the study, the event definitions, and the observation windows. With no comparator, the counts describe what was recorded during the defined periods; they do not identify what caused an event or estimate a treatment-related excess in risk.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary safety results are descriptive. The registry reports 4 participants with at least one TEAE and 0 participants with a TESAE. The safety population consisted of participants who began the infusion, and 4 participants were listed as at risk for each event category. In a single-group study, these counts report observed events in the treated group; they do not estimate a difference between treatments.
The distinction between an event and a treatment-caused event matters. The registry’s adverse-event definition does not require a causal relationship to study treatment. A TEAE is defined by its timing relative to infusion and the stated follow-up period, including worsening of a pre-existing condition. Therefore, the reported count should not be read as a count of events proven to have been caused by SAGE-547. The same caution applies to the serious-event count.
The zero recorded TESAEs means that no participant in the stated safety population was reported as having a treatment-emergent serious adverse event within the defined period. It is not evidence that serious events could never occur, nor does it establish the rate that would arise in a larger or different population. A small study provides limited information about events that are uncommon, and the absence of a comparator prevents a direct contrast with another group.
The registry describes the trial as a proof-of-concept study and lists efficacy-related outcomes, including change from baseline in HAM-D-17 total score. However, no numerical result for that outcome is reported in the record. Efficacy findings and the results of the listed pharmacokinetic outcomes are also not reported in the registry record available for this analysis. The study’s stated aims should not be mistaken for evidence that those outcomes demonstrated a particular effect.
No inferential analysis is listed in the registry record. Thus, there is no reported statistical test or model result to support a claim of comparative benefit or harm. The information is best understood as a small, open-label safety and proof-of-concept record: it identifies the reported event counts and outcomes the study intended to assess, while leaving comparative effects, uncertainty estimates, and several outcome results unreported.
9. Statistical Methods Explained
Interpretation begins with the study structure. A single-group design observes participants receiving the intervention without a parallel control group. Open-label means masking was not used, as recorded in the registry. This design can describe events and measurements in the study group, but it does not supply a randomized contrast. Without such a contrast, differences from a baseline measurement or the occurrence of an event cannot be attributed to treatment alone.
What does a participant count represent?
The primary endpoint is a count of participants with TEAEs and TESAEs. A participant-level count asks whether a participant experienced an event meeting the stated definition during its time window. It is different from counting every event episode: one participant may experience more than one event, while the participant count still records that person as having an event. The registry reports participant counts, not a detailed episode-level breakdown.
The event definitions determine what enters the count. For TEAEs, the record specifies onset after the start of infusion, or worsening of a pre-existing medical condition, and a follow-up period through Day 11. For TESAEs, the analogous window extends through Day 34. The definitions do not require that an event be judged caused by the intervention. The count should therefore be interpreted as treatment-emergent under the registry definition, not as a causal attribution.
Why does the design limit inference?
In a randomized comparison, treatment groups can be contrasted under a specified analysis plan. Here, allocation is listed as not applicable, the model is single group, and no masking is recorded. There is no control-group estimate against which to judge the event counts or changes in a clinical measure. General statistical principle: a comparison group helps distinguish outcomes associated with an intervention from outcomes that could occur for other reasons. The registry record does not provide that comparison.
Even if a within-participant outcome such as HAM-D-17 changes from baseline, a change alone does not establish what would have happened over the same period without the intervention. The registry lists change from baseline as a secondary outcome, but a numerical result for it is not reported in the registry record. The record also lists pharmacokinetic outcomes; their presence in the outcome list is not itself a result.
What can an uncertainty interval add?
General statistical principle: a confidence interval expresses the range of values reasonably compatible with an estimate under a specified statistical model and sampling assumptions. It communicates precision as well as the estimated value. The registry record does not report a confidence interval for the primary event counts. With only the reported counts and no inferential analysis, readers should not treat the point counts as precise estimates of event frequency beyond this study group.
Counts can be especially limited when events are uncommon. General statistical principle: observing no events in a small study does not prove that the underlying chance of an event is zero. More observations may reveal events not seen in a small sample. The record’s zero TESAE count is therefore a statement about what was observed in the defined study population and time window, not a guarantee about other participants or longer observation.
What does the analysis record establish?
The registry lists no analyses. It does not report a test statistic, model, p-value, adjusted estimate, or confidence interval for the primary endpoint. A detailed statistical plan, including any planned handling of interim analyses or multiplicity, is not reported in the registry record. Those details should not be inferred from the endpoint list or from the fact that the study was Phase 2.
The record identifies a safety population as all participants who began infusion. That population definition is relevant to interpreting the event counts: the counts concern participants who started treatment, rather than an unspecified larger group. The registry does not report additional analysis-population definitions for efficacy or pharmacokinetic outcomes in the information available for this analysis.
How should planning calculations be read?
General statistical principle: sample-size calculations are planning tools based on assumptions about an effect, variability, significance level, allocation, and analysis method. They are not observed results and are not evidence that a study had a particular probability of detecting an effect. The registry record does not report a sample-size justification or the assumptions used to set enrollment. Any planning illustration based on an observed effect is not the study’s own design rationale and must not be interpreted as observed power.
For this study, the absence of a comparator is especially important for planning interpretations: the observed safety counts do not constitute a treatment-versus-control effect. No comparison-based efficacy estimate or statistical analysis is reported in the registry record. Accordingly, the methods support a descriptive reading of the recorded counts, not a causal or comparative conclusion.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary safety endpoint and multiple secondary outcomes. These include pharmacokinetic measures and change from baseline in HAM-D-17 total score. When several outcomes are assessed, the chance of at least one apparently notable result can increase if each is tested separately. General statistical principle: a multiplicity strategy may control this issue, for example by specifying which outcomes are confirmatory and how tests are adjusted. Such a strategy is not reported in the registry record, and no analyses are listed.
The registry record does not report a statistical analysis plan, missing-data rules, imputation methods, or details about how incomplete outcome measurements were handled. It also does not report numerical results for the listed secondary outcomes in the information available for this analysis. No assumptions should be made about whether missing measurements occurred or how they might have affected a result.
The primary safety population is defined as all participants who began infusion. The event counts are reported for that population. Additional analysis populations for efficacy or pharmacokinetic outcomes are not reported in the registry record. Without further information, it is not possible to determine whether every participant contributed data to every listed secondary outcome or how any unavailable measurement was treated.
These reporting gaps do not change the descriptive meaning of the posted adverse-event counts, but they limit assessment of the broader analysis strategy and of any outcome results not reported. In particular, the registry does not support conclusions about multiplicity-adjusted evidence, missing-data sensitivity, or consistency across analysis populations.
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 |
|---|---|---|---|
| SAGE-547 | 0 | 4 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| SAGE-547 | 0 of 4 |
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 |
|---|---|
| SAGE-547 | 4 of 4 |
Most frequent non-serious adverse event terms
| Event term | Organ system | SAGE-547 |
|---|---|---|
| Sedation | Nervous system disorders | 2 of 4 |
| Infusion Site Discomfort | General disorders | 1 of 4 |
| Infusion Site Erythema | General disorders | 1 of 4 |
| Infusion Site Pain | General disorders | 1 of 4 |
| Blood Thyroid Stimulating Hormone Increased | Investigations | 1 of 4 |
| Dizziness | Nervous system disorders | 1 of 4 |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | 1 of 4 |
| Rash | Skin and subcutaneous tissue disorders | 1 of 4 |
| Flushing | Vascular disorders | 1 of 4 |
The serious adverse event result is a participant count: 0 participants were reported with a treatment-emergent serious adverse event, with 4 listed as at risk in the SAGE-547 group. The registry’s serious-event window extends through Day 34 and includes events beginning after infusion started, or worsening of a pre-existing medical condition, under its stated definition. The count does not require that an event be judged caused by the intervention.
A zero count means no qualifying serious event was recorded for participants in the stated safety population during that window. It does not establish that the underlying risk is zero or rule out events outside the observed participants or time period. General statistical principle: the precision of a safety estimate depends on the amount and duration of observation, and uncommon events may not appear in a small study.
The registry also reports 4 participants with TEAEs, using the shorter window through Day 11. This broader event count and the serious-event count refer to different event categories and follow-up windows, so they should be read according to their own definitions. The counts are not a comparison with an untreated or control group and do not show how many events were judged treatment-related.
12. What the Result Does, and Does Not, Mean
The study records safety observations among adult female participants with severe postpartum depression who received SAGE-547 in an open-label, single-group setting. The posted primary endpoint reports 4 participants with TEAEs and 0 with TESAEs. Those figures describe the events recorded under the registry definitions and observation windows. They do not show whether the observed events were caused by treatment.
The results do not establish a comparative safety profile because there was no control group. Without a comparator, the record cannot quantify whether event counts were higher or lower than they would have been under another treatment or without the intervention. The small enrollment also limits what can be learned about less common events. A zero serious-event count in this study is not proof that such events cannot occur.
The registry says the study was designed to assess efficacy, as well as safety, tolerability, and pharmacokinetics. It lists change from baseline in HAM-D-17 total score and several drug-concentration outcomes. However, those numerical results are not reported in the registry record available for this analysis. A planned outcome is not evidence of a result, and no claim about symptom change or pharmacokinetic findings can be drawn from the outcome list alone.
The record also does not report an inferential analysis, a confidence interval, or a statistical analysis plan. Consequently, the available evidence supports a descriptive account of the recorded safety counts, not a claim of efficacy, a causal treatment effect, or a precise estimate that generalizes to a wider population. The findings should be interpreted within the study’s open-label, single-group design and its stated observation periods.
13. Why This Trial Matters Statistically
This study illustrates why a registry record needs to be read through both its results and its design. The primary endpoint is a count of participants with defined adverse events, but the study has no randomized comparator. Its reported counts therefore answer a limited descriptive question: what was recorded among participants who began the SAGE-547 infusion during the specified periods? They do not answer how those counts compare with another treatment or with no study intervention.
It also demonstrates the difference between an outcome being planned and an outcome being reported. The registry lists pharmacokinetic measures and a depression-scale change outcome, but numerical results for those measures are not reported in the record available for this analysis. A study’s aims and endpoint list should not be mistaken for evidence about the outcomes.
The small enrollment makes careful wording particularly important. Counts are concrete observations, but they do not by themselves provide a precise estimate of event frequency or address uncommon events. In particular, the absence of reported serious events does not establish that the risk is absent. The event windows and definitions further shape what the counts mean.
Finally, the registry reports no analyses or statistical plan. This limits assessment of inferential methods, multiplicity, and missing-data handling. The study is informative as a record of a small proof-of-concept investigation and its stated safety observations, while leaving comparative and inferential questions unanswered.
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 main limitation is the single-group, open-label design. There was no randomized control group and no masking, so the record cannot provide a direct treatment comparison. Changes in clinical measures, if reported, could not be attributed to the intervention on the basis of a within-group observation alone. The registry does not provide numerical efficacy results in the information available for this analysis.
Enrollment was 4, which restricts the range of safety conclusions that can be drawn. The reported zero TESAEs is limited to the participants in the stated safety population and the follow-up period through Day 34. It does not rule out uncommon events or events outside that period. The record reports a TEAE count but does not provide detailed event terms in the serious-event list.
The registry’s event definitions are based on timing and include worsening of pre-existing conditions; they do not require causal attribution. As a result, the counts should not be described as events caused by SAGE-547. The record also does not report a detailed statistical analysis plan, confidence intervals, missing-data procedures, or multiplicity strategy.
The listed secondary outcomes indicate intended assessments, not necessarily reported results. Numerical findings for the listed pharmacokinetic measures and HAM-D-17 change are not reported in the registry record available for this analysis. The complete dosing description is also not reported in the information. Finally, a sample-size justification is not reported in the registry record, so the enrollment rationale cannot be evaluated from the available information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression — NCT02285504.
- Registry record last updated 2025-09-15; status last verified 2021-11.
- Results first posted 2021-12-02.
- 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.
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18. Record Summary
NCT02285504 is a completed Phase 2, open-label, single-group study of SAGE-547 in adult female participants with severe postpartum depression. The registry records enrollment of 4 and an intravenous infusion intervention. Its primary endpoint counts TEAEs through Day 11 and TESAEs through Day 34. The safety population includes participants who began infusion.
The registry reports 4 participants with TEAEs and 0 with TESAEs. These descriptive counts are not a comparison with a control group and do not establish causality. The record lists pharmacokinetic outcomes and change from baseline in HAM-D-17 as secondary outcomes, but their numerical results are not reported in the registry record available for this analysis. No analyses are listed, and a detailed statistical plan is not reported.