An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay (NCT01507155), a non-randomized na study. The primary outcome is Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months.

2. Clinical Question

The registry record frames the study around clinical utility and patient outcomes after use of the Genecept Assay. It describes collecting responses from patients and clinicians with the intention of correlating those responses with subject genetic data. That aim is broader than the primary endpoint alone: the primary endpoint concerns a clinician-rated measure at 3 months, while the listed secondary outcomes include patient-reported measures and other scales.

The study title and outcome description use the language of efficacy, but the design recorded is open label, non-randomized, and single group. There is no randomized treatment assignment or identified control group against which to estimate a comparative treatment effect. The primary question can therefore be read as asking what outcome was recorded in this study population, not as establishing what would have happened under a different testing or treatment strategy. The primary numerical result, including its uncertainty, is not reported in the registry record.

3. Trial Design

This is a completed, open-label study of the Genecept Assay, sponsored by Genomind, LLC. The registry records the study as non-randomized, with no masking and a single-group model. Its phase is recorded as NA. Enrollment is listed as 685. The recorded start is 2013-04, and primary completion is recorded as 2014-05.

The registry describes two types of study participant: patients who consented to using the assay and clinicians who ordered it for patients. The arm descriptions concern patient-reported measures and clinician-reported outcomes. The patient description specifies people age 18 and older with Major Depressive Disorder or Generalized Anxiety disorder who received genetic testing and completed patient scales. The clinician description concerns prescribing clinicians responsible for treatment of eligible patients for whom the assay was used.

These reporting groups should not be interpreted as randomized study arms. The registry explicitly identifies the study as non-randomized and notes that the arms are not a like-for-like control comparison. The listed counts at risk for adverse-event reporting also differ between the clinician-reported and patient-reported groups, but those counts do not establish a comparative treatment allocation. The registry does not report a separate control intervention or a randomization procedure.

The intervention is the Genecept Assay, classified as a device. The brief description says responses from patients and clinicians were to be collected with the intention of correlating them with subject genetic data. Further details about recruitment, follow-up completion, assay interpretation, or how assay findings informed treatment are not reported in the registry record. Nor is a detailed protocol or statistical analysis plan reported. Consequently, the design description supports an account of the study’s structure, but not a reconstruction of its operational procedures.

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.

Overall Study

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 Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months, measured over 3 months.

The primary endpoint is titled “Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months.” It is recorded in participants, with the parameter described as a number, and the timeframe is 3 months. The description says the outcome was intended to assess illness severity using the clinician-administered CGI-I scale. The scale ranges from scores 1-7, with 1 meaning very much improved and 7 meaning very much worse since initiation of treatment.

A clinician-rated scale can capture an assessment made by a treating clinician rather than relying only on a participant’s self-report. In general, a baseline-to-follow-up endpoint is intended to describe how a measure changes over time. It can be useful when the research question concerns the course of a condition after an intervention is introduced. The registry’s title and description identify that general role, but do not report the baseline or follow-up score distributions, the exact calculation used for change, or the primary result.

The endpoint description also does not report how the clinician’s rating was collected, whether ratings were assessed consistently across clinicians, or how missing ratings were handled. Because the study was open label, the registry does not describe masking of clinicians to assay information or treatment decisions. These omissions matter when interpreting a clinician-rated outcome: the recorded score reflects the measurement process as well as the participants’ clinical state. The primary endpoint definition is therefore clear at a broad level, but the result and the details needed to assess its precision and measurement properties are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What can a single-group outcome show?

General: A single-group study can describe measurements collected from participants who receive or use an intervention. If a measure is recorded at baseline and again later, the observations can describe change over time within the study group. Such a change is not automatically an estimate of the intervention’s causal effect. Without a suitable comparison group, it is difficult to distinguish intervention-related change from other influences on participants or on how outcomes are measured.

For this study, the registry records a single-group model and a non-randomized allocation. It describes patient-reported and clinician-reported outcome groups, but specifically cautions that these are not like-for-like control arms. They reflect different reporting roles rather than a randomized contrast. The registry does not report a comparative effect estimate. Therefore, interpretations should distinguish a description of observed outcomes from a comparison of what would have happened under an alternative approach.

Why does randomization matter?

General: Randomization assigns participants to study groups by chance. When carried out appropriately, it can make groups more comparable with respect to both measured and unmeasured factors, supporting a more credible comparison of outcomes. In a non-randomized study, the factors influencing who receives an intervention or how it is used can also be related to outcomes. Statistical adjustment may address some recorded differences, but it cannot guarantee that unmeasured differences have been removed.

The registry labels this study non-randomized and does not identify a control group. It also does not report a statistical adjustment strategy. The primary endpoint may have been intended to describe change from baseline, but the registry does not report the analysis used to estimate that change. The design label alone does not reveal which analysis was performed, and an analysis cannot be inferred from the endpoint title.

What does an uncertainty interval contribute?

General: A confidence interval expresses the range of estimates compatible with a statistical procedure under its assumptions. A narrow interval indicates greater precision than a wide interval, while either interval can include values with different practical interpretations. An interval does not by itself establish that a result is clinically important or that an intervention caused it. Its interpretation depends on the endpoint, the analysis, and the study design.

No confidence interval or other uncertainty estimate for the primary outcome is reported in the registry record. Neither the result itself nor the precision of that result can therefore be assessed from the registry entry. A p-value, if reported, would not replace an effect estimate and its uncertainty; however, no p-value for the primary outcome is reported either. The registry also does not report a statistical null hypothesis or a decision threshold.

How should a scale endpoint be interpreted?

General: A scale produces measurements according to its scoring rules. Interpreting a scale requires knowing what its values represent, how the score was collected, and how the analysis used the scores. If a scale is treated as a continuous measurement, an analysis may summarize average scores or changes. If it is grouped into categories, an analysis may instead report counts or proportions in those categories. Those approaches answer different questions, and the selected approach should be described rather than assumed.

The registry identifies CGI-I as a clinician-administered scale with scores 1-7 and describes the direction represented by the endpoints. It records the primary parameter as a number of participants, but does not report a threshold defining response or explain how that count relates to a change score. It also does not report whether the outcome was analyzed as a score, a category, or another summary. The measure’s name and scale range do not establish the statistical analysis.

Why do outcome completeness and analysis populations matter?

General: Missing outcome measurements can affect an estimate if the availability of a measurement is related to participants’ outcomes. Analyses may use different populations, such as everyone enrolled, everyone with a follow-up measurement, or a prespecified subset. The population used changes the interpretation of the result. Statistical methods for missing data require assumptions, and readers need a clear account of missingness and analysis populations to judge how robust a finding may be.

The registry does not report how many participants contributed primary endpoint measurements, how missing assessments were handled, or which analysis population was used. The enrollment entry alone does not identify the number included in any particular endpoint analysis. The record also does not state whether an analysis population was defined in advance. These details cannot be inferred from the listed outcome groups or adverse-event denominators.

What analysis plan is documented?

The registry record does not report the statistical analysis plan, sample-size justification, interim analyses, or the methods used for the primary and secondary outcomes. It lists two outcome measures and zero analyses, but provides no analysis output for the primary endpoint. No adjustment for covariates, handling of repeated measurements, or procedure for multiple outcomes is reported. These omissions limit reproducibility: a reader cannot determine whether the posted analysis followed a prespecified plan or how analytical choices may have affected the reported results.

General: A statistical plan ordinarily specifies the endpoint definitions, analysis populations, model or summary approach, missing-data procedures, and how uncertainty will be quantified. A sample-size calculation is a planning tool based on design assumptions; it is not an observed outcome and does not establish the precision of the final result. The registry does not report the study’s own sample-size rationale. Without a documented plan and posted primary result, statistical methods cannot be reconstructed from this record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists the primary CGI-I endpoint and secondary outcomes involving QIDS-SR16, Q-LES-Q-SF, UKU Side Effects, and SAS at 3 Months. It also records two outcome measures and zero analyses, without explaining how those entries correspond to the listed outcomes. The statistical analysis plan is not reported in the registry record. In particular, the record does not state whether one outcome was designated as the principal basis for inference, whether secondary outcomes were exploratory, or whether any multiplicity procedure was planned.

General: When several outcomes or comparisons are tested, the chance of obtaining at least one apparently unusual result can increase. Prespecifying a primary outcome and a strategy for interpreting secondary outcomes helps readers distinguish confirmatory questions from exploratory ones. No correction should be assumed when the analysis plan is unavailable, and no conclusion about whether multiplicity was addressed can be made from the outcome list alone.

Missing-data handling is also not reported. The record does not say how many participants had a baseline or 3-month CGI-I assessment, whether incomplete assessments were excluded, or how missing measurements were treated. It does not identify the analysis population for the primary or secondary outcomes. These omissions matter because the set of participants contributing data and the assumptions used for missing outcomes can affect both an estimate and its uncertainty.

The registry describes patient and clinician reporting groups, but does not state whether every eligible participant was included in every outcome analysis. The adverse-event at-risk counts do not establish the analysis population for efficacy outcomes. No imputation procedure, sensitivity analysis, or assessment of missingness is reported in the registry record. As a result, the completeness and robustness of outcome analyses cannot be evaluated from the available registry information.

11. 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.

The registry records adverse-event figures separately for the clinician-reported and patient-reported outcome groups. For clinician-reported outcomes, the at-risk count is 625, with 0 serious adverse events and 0 other adverse events recorded. For patient-reported outcomes, the at-risk count is 60, with 0 serious adverse events and 0 other adverse events recorded. These are registry counts for the respective reporting groups; they should not be treated as a randomized comparison between groups.

The figures indicate that no events were entered in either adverse-event category for those stated at-risk counts. They do not, on their own, demonstrate that no adverse events occurred outside the reporting process or that all participants were observed for the same duration. The registry does not report how adverse events were defined, solicited, adjudicated, or followed, nor does it explain whether the at-risk counts refer to all participants exposed to the assay or to a particular reporting population. The death entries are null, so death information is not reported in the registry record. These safety entries should therefore be read as limited registry reporting, not as a complete account of safety.

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

The record establishes that a completed, open-label, non-randomized, single-group study of the Genecept Assay was registered, and it describes a clinician-rated primary endpoint at 3 months alongside patient- and clinician-reported outcomes. It also provides adverse-event counts for two reporting groups. This information helps readers understand the study’s stated purpose, participant roles, and measurement framework.

It does not establish the size or direction of change in the primary endpoint. The registry record does not report the primary result, its uncertainty, or the methods used to analyze it. It therefore cannot support a conclusion about whether participants’ CGI-I scores changed, how precisely any change was estimated, or whether a change was clinically important. The listed secondary outcomes likewise do not establish results because their numerical findings are not reported in the registry record.

The study design also does not support a straightforward causal comparison. There is no randomized comparator identified, and the reporting groups are not like-for-like treatment arms. A before-and-after observation, if one were reported, could describe the course of outcomes within the study but would not by itself separate the effect of assay-guided treatment from other influences. The registry does not report a causal analysis that would address this limitation.

The adverse-event entries show zero recorded serious and other adverse events in each stated reporting group, but do not establish a complete absence of harms. Definitions, collection methods, and follow-up details are not reported. In summary, the registry describes what the study set out to assess and some aspects of its design, but does not provide the outcome evidence needed to estimate efficacy or to make a comprehensive safety assessment.

13. Why This Trial Matters Statistically

This study is statistically notable because it combines a broad clinical-utility aim with a design that is descriptive rather than a randomized comparison. The registry intended to collect information from patients and clinicians and relate it to subject genetic data. That goal raises several distinct statistical questions: how each outcome was measured, how patient and clinician reports were connected, what analysis population was used, and what comparison would support an interpretation about assay-guided care. The registry describes the aim, but does not report the methods or results needed to answer those questions.

The distinction between outcome-reporting groups and treatment-comparison groups is especially important. Patient-reported and clinician-reported measures can provide different perspectives, but they do not automatically constitute comparable study arms. The record marks the study as single group and non-randomized, and explicitly cautions against treating the groups as a like-for-like control comparison. This prevents a common interpretive error: reading separate reporting counts as evidence from a controlled contrast.

The endpoint also makes measurement choices consequential. A clinician-administered CGI-I score may summarize a clinical judgment, while the listed secondary outcomes include measures with different reporting purposes. Understanding how these measures were scored, analyzed, and handled when missing would be necessary to assess the statistical evidence. The registry does not report those details or the primary result.

More broadly, the record illustrates why outcome definitions, analysis plans, and uncertainty estimates are central to clinical research reporting. A named endpoint and a completed status do not reveal the magnitude, precision, or causal interpretation of a result. Transparent reporting of these elements would allow readers to distinguish a descriptive observation from evidence supporting a comparative claim.

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 principal limitation for interpreting this study from the registry record is that the primary numerical result is not reported. The record does not provide a CGI-I estimate, baseline or follow-up summaries, or an uncertainty interval. It also does not report numerical findings for the listed secondary outcomes. As a result, the outcome evidence cannot be evaluated for magnitude or precision.

The design is non-randomized, open label, and single group, with no like-for-like control comparison identified. This restricts causal interpretation even if within-group change results were available. The registry does not report a statistical adjustment strategy that might address measured differences or other sources of bias. It also does not explain how clinicians’ knowledge of assay results or treatment choices related to outcome assessment.

Important implementation details are not reported in the registry record, including the analysis population, completeness of outcome measurements, missing-data procedures, endpoint scoring and analysis methods, and the statistical plan. The record does not report a sample-size justification or interim analyses. It is also unclear from the registry entry how the two listed outcome measures relate to the endpoint descriptions and the zero analyses recorded.

Safety interpretation is limited by the lack of reported event definitions, ascertainment procedures, follow-up details, and death information. The zero event counts should not be interpreted as proof that no harms occurred. Finally, the study’s stated intention to correlate responses with genetic data is not accompanied by reported analytical details or results. These limitations concern what can be established from the registry record and do not imply that unreported procedures or analyses were or were not carried out.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay — NCT01507155.
• Registry record last updated 2016-06-08; status last verified 2016-05.
• Results first posted 2016-05-02.
• 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.

18. Record Summary

The registry record describes a completed, open-label, non-randomized, single-group study of the Genecept Assay sponsored by Genomind, LLC. Enrollment is listed as 685; the recorded start is 2013-04 and primary completion is 2014-05. The study included patient- and clinician-reported outcomes, with the primary endpoint focused on change from baseline in clinician-administered CGI-I scores at 3 months.

The record identifies secondary measures and reports adverse-event counts by reporting group. It does not report the primary efficacy result, uncertainty estimates, statistical analysis plan, analysis populations, or missing-data methods. The patient- and clinician-reported groups are not a like-for-like control comparison. Accordingly, the registry entry describes study intent and structure but does not provide enough outcome information to estimate efficacy or fully characterize safety.