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 Pharmacogenomics for Antidepressant Guidance and Education 1 (PAGE-1_AG1) (NCT01426516), a randomized na study. The primary outcome is Efficacy Measured by Change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Adjusted for Baseline Severity, at 6 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01426516 |
| Phase | NA |
| Condition | Major Depressive Disorder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 29 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Genomind, LLC |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned outpatient adults with treatment-resistant depression, in the context of major depressive disorder. The official title describes treatment resistance, while the primary outcome population field reads “Invalid Data Collection.” The registry record therefore does not give a usable, detailed description of the analyzed population or eligibility criteria.
Intervention
In the Genecept Assay arm, participants provided a DNA sample for genetic testing, and treatment decisions took the genetic results into account. The registry record does not describe the particular treatment decisions made or how clinicians used individual results.
Comparator
In the treatment-as-usual arm, participants also provided a DNA sample, but did not receive the genetic results. Their treatment was described as treatment as usual. The record does not define usual care in further detail.
Primary question
The primary question was whether assay-guided treatment differed from treatment as usual in depression severity at 6 months, measured by change in the Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) and adjusted for baseline severity. The registry record does not report an estimate of that comparison, so its direction and precision cannot be assessed.
3. Trial Design
NCT01426516, titled Pharmacogenomics for Antidepressant Guidance and Education 1 (PAGE-1 AG1), is recorded as a randomized, single-masked, parallel-group study. Its condition is major depressive disorder, and its official title describes outpatient adults with treatment-resistant depression. The registry lists enrollment of 29 and a terminated status. The study start is recorded as 2011-09 and primary completion as 2014-06. The reason for termination is not reported in the registry record.
Participants were assigned to Genecept Assay-guided treatment or treatment as usual. Both arm descriptions include providing a DNA sample for genetic testing. The distinction is that the Genecept Assay arm used the genetic results in treatment decisions, while the treatment-as-usual arm did not provide participants with the results. The record does not state how the assay results were translated into particular treatment choices, or define the care received in the comparison arm beyond its treatment-as-usual label.
The record labels the study single-masked but does not report which people involved in the study were masked, what information was concealed, or when masking ended. Randomization describes the intended assignment process; it does not by itself establish that the groups were similar in every characteristic, particularly in a study with limited enrollment. The record does not provide enough information to assess the randomization procedure, allocation concealment, or balance at baseline.
The primary outcome was planned at 6 months. The study summary also refers to depression severity at 3 months and follow-up out to 6 months, but detailed measurement schedules are not reported. The registry lists five outcome measures and four secondary outcome topics: clinician treatment choice before and after assay results were made available, self-reported quality of life, cost, and satisfaction with assay-guided treatment. Detailed results for these outcomes 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.
Overall Study
| Stage | Treatment as Usual (TAU) | Genecept Assay |
|---|---|---|
| STARTED | 12 | 17 |
| COMPLETED | 12 | 17 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Invalid Data Collection
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 | Treatment as Usual (TAU) | Genecept Assay | Total |
|---|---|---|---|---|
| Participants analysed | 12 | 17 | 29 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 12 | 17 | 29 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | Years | 44 (24 to 59) | 46 (23 to 65) | 45 (23 to 65) |
| Sex: Female, Male: Female | Participants | 11 | 11 | 22 |
| Sex: Female, Male: Male | Participants | 1 | 6 | 7 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 11 | 17 | 28 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Efficacy Measured by Change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Adjusted for Baseline Severity, at 6 Months, measured over 6 months.
| 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 endpoint concerns change in depression severity measured with the Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), with the comparison adjusted for baseline severity. It is specified at 6 months and is intended to compare assay-guided treatment with treatment as usual. A change measure focuses on how a participant’s reported symptom score changes over follow-up, rather than relying only on the score at the final assessment. Baseline adjustment is intended to account statistically for initial severity when comparing the groups. The record does not describe the exact calculation of change or the statistical model used for adjustment.
The registry description gives a scoring range of 0-27, with 0 described as no signs of depression and 27 as severe depression. It describes combining the highest score within specified sleep items, weight items, and psychomotor items, together with scores for six major depressive disorder symptom domains. These details identify the intended content and direction of the scale, but do not provide observed scores or changes for either group.
A symptom scale can provide a structured way to compare reported severity, but the meaning of a group difference depends on the observed estimate, its uncertainty, and the quality and completeness of the measurements. None of those outcome results is reported in the registry record. The registry also does not report an interpretation threshold for a clinically meaningful difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison with a primary endpoint of baseline-adjusted change in QIDS-SR at 6 months. However, it reports no analysis of the primary outcome: the analysis count is 0, and no group outcome summaries, treatment-effect estimate, confidence interval, or p-value are listed. There is therefore no posted estimate from which to assess whether the groups’ depression-severity outcomes differed, in what direction, or with what precision. This absence of a result is not evidence that the treatments had the same effect, nor is it evidence that one approach was better.
The enrollment figure is 29, but enrollment alone does not establish how many participants contributed primary-outcome data or how many were included in an analysis. The record does not report analysis populations, follow-up completion, missing outcome data, or the handling of participants who did not complete assessments. It also does not give group-specific primary-outcome values. Accordingly, the registered design cannot be used to reconstruct a treatment effect from the posted information.
The study status is terminated. That status identifies the recorded study status; the reason for termination is not reported in the registry record. It should not be interpreted as an explanation for the lack of posted analyses. The record also does not report whether analyses were conducted outside the registry or whether results were published elsewhere.
The primary outcome is described as baseline-adjusted, but the model, covariates, assumptions, and method for estimating uncertainty are not reported. There is no basis for determining whether the registered endpoint was analyzed as a change score, a follow-up score adjusted for baseline, or another implementation of baseline adjustment. Those methods can target related but not identical quantities, and their interpretation depends on the analysis details.
General statistical interpretation distinguishes an estimated effect from its uncertainty. A confidence interval, when reported, indicates a range of values compatible with the data under the analysis assumptions; it is not a guarantee that the true effect lies within that range. A p-value, when reported, describes how unusual the data would be under a specified null model; it does not measure the size or clinical importance of an effect. Neither measure is available for the primary comparison in this registry record.
The posted safety counts do not fill this efficacy gap. They concern recorded adverse-event categories, not the primary depression-severity endpoint. The available event figures can be described as recorded, but they do not establish the primary treatment effect or explain why the study was terminated. Overall, the registry describes what the study intended to compare, but does not provide results that permit an efficacy estimate or a direct assessment of its precision.
9. Statistical Methods Explained
The registry identifies a randomized, parallel-group design and a baseline-adjusted primary outcome. It does not report the detailed statistical analysis plan or the methods used to analyze the outcome. The concepts below explain how such design features are generally interpreted; they are not a description of undocumented analyses in this study.
What does randomization contribute?
In general, randomization assigns participants to comparison groups through a chance-based process. Its purpose is to reduce systematic differences between groups at assignment, including differences in measured and unmeasured characteristics. Randomization does not ensure identical groups, and chance imbalances can occur. The value of randomization is strongest when assignment is properly generated and concealed. The method used to generate or conceal assignment is not reported in the registry record, so those implementation details cannot be assessed.
A parallel-group design means participants are assigned to a study arm and the arms are compared over follow-up. Here, the recorded comparison is assay-guided treatment versus treatment as usual. The trial is labeled single-masked, but the record does not identify who was masked or which study information was concealed. Masking can, in general, reduce the influence of expectations on treatment decisions, participant reports, or outcome assessment, depending on who is masked. Without the masking details, it is not possible to evaluate those protections in this study.
What does baseline adjustment mean?
The primary endpoint specifies change in QIDS-SR adjusted for baseline severity. In general, adjustment accounts for the starting value when comparing follow-up outcomes. This can improve precision when baseline severity is related to the later score, and it can address chance differences in starting severity. The exact implementation matters: a model may compare follow-up scores while accounting for baseline, or may analyze change from baseline with additional adjustment. The registry record does not state which approach, model, or covariates were used. It also does not report whether model assumptions were checked.
Change scores and baseline-adjusted follow-up comparisons are not automatically interchangeable. Their performance and interpretation can depend on measurement reliability, the association between baseline and follow-up scores, and the analysis model. These are general considerations, not findings about this study. Without the analysis specification and outcome data, the registered endpoint cannot be independently reconstructed.
How should uncertainty be understood?
In general, an effect estimate expresses the size and direction of a comparison, while an uncertainty measure conveys how much the estimate could vary under the analysis assumptions. A confidence interval is one common way to present that uncertainty. A narrow interval indicates greater statistical precision than a wide interval, but precision does not alone establish clinical importance. A p-value addresses compatibility with a specified null hypothesis and model; it does not say how large an effect is or whether it matters to patients. The registry record reports no primary effect estimate, confidence interval, or p-value, so these interpretations cannot be applied to the trial’s primary comparison.
Statistical significance and clinical importance are different questions. A result can be estimated precisely yet be small, or be potentially important but estimated imprecisely. Assessing clinical importance would also require a justified threshold or context for interpreting QIDS-SR change. Such a threshold is not reported in the registry record.
What can the event counts tell readers?
Adverse-event counts are descriptive unless accompanied by a defined comparison and an appropriate analysis. For rare events, small counts can be especially imprecise, and a zero recorded count does not establish that an event could never occur. The posted serious-event figures record no affected participants in either arm, while the other adverse-event category has nonzero affected counts. The record does not provide event descriptions, timing, severity, or a statistical comparison. These figures therefore should not be treated as a complete assessment of safety or as evidence about the primary efficacy endpoint.
What analysis details are absent?
The registry record does not report the statistical model, test, covariates beyond the stated baseline adjustment, standard-error method, confidence-interval method, or handling of missing data. It does not report an intention-to-treat or per-protocol analysis population, or any interim analysis. The sample-size justification and planned statistical analysis are not reported in the registry record. These omissions prevent readers from checking how the registered question was translated into an analysis or whether the analysis matched the intended design.
In general, a prespecified analysis plan helps distinguish confirmatory decisions from choices made after results are known. That plan can specify outcome definitions, analysis populations, missing-data procedures, multiplicity handling, and model assumptions. The absence of those details in the registry means readers cannot determine which procedures were intended or used. No unreported method should be inferred from the design label or endpoint description.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures, including the primary depression-severity endpoint and secondary measures concerning clinician treatment choice, quality of life, cost, and satisfaction. Considering multiple outcomes or multiple assessments can create multiplicity: the more comparisons examined, the greater the opportunity for chance findings if each is interpreted independently. In general, a statistical plan may identify a primary comparison and specify whether and how secondary comparisons will be adjusted or treated as exploratory. Multiplicity procedures are not reported in the registry record.
The registry’s skip note indicates that the primary outcome has several categories or time points and was not reduced to one comparison. Thus, the record does not offer a single posted primary-outcome comparison to interpret. The specific categories or time points and any hierarchy among them are not sufficiently reported for assessing how multiple primary-outcome analyses might have been handled. No multiplicity-adjusted estimates or results are reported.
Missing outcome data can affect both the analysis population and the interpretation of a treatment comparison. In general, readers need to know how many participants had measurements at each assessment, why observations were missing, and what assumptions or methods were used to address missingness. The registry record does not report these details for the primary endpoint or the secondary measures. It does not report whether any imputation, likelihood-based method, or complete-case analysis was used, so none should be assumed.
The primary outcome population field is recorded as “Invalid Data Collection,” and the analysis count is 0. These entries do not identify an analyzable population or an analysis set. The registry record does not say whether all randomized participants were intended to be analyzed according to assigned arm, whether adherence affected inclusion, or whether another population was used. Consequently, neither the influence of missing data nor the relationship between enrollment and outcome analysis can be evaluated.
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 |
|---|---|---|---|
| Treatment as Usual (TAU) | 0 | 12 | 0.0% |
| Genecept Assay | 0 | 17 | 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 |
|---|---|
| Treatment as Usual (TAU) | 3 of 12 |
| Genecept Assay | 6 of 17 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment as Usual (TAU) | Genecept Assay |
|---|---|---|---|
| Minor to Moderate Adverse Effects to Medications | Psychiatric disorders | 3 of 12 | 6 of 17 |
The registry reports serious adverse events for the treatment-as-usual arm as 0 affected among 12 at risk, and for the Genecept Assay arm as 0 affected among 17 at risk. In the registry’s other adverse-event category, 3 were affected among 12 at risk in treatment as usual, and 6 were affected among 17 at risk in the Genecept Assay arm. These are the recorded figures, not a statistical comparison between arms.
A count of zero serious events means no affected participants were recorded in that category for the listed group; it does not demonstrate that serious events are impossible or establish equivalence in safety. The other-event figures do not identify the event types, when they occurred, their severity, or whether they were considered related to treatment. The registry record also does not report a comparative analysis or enough detail to interpret the event categories beyond their labels.
Deaths are not reported in the registry record. The adverse-event entries alone cannot characterize the full safety profile, and they do not address the primary depression-severity outcome. They should be read as limited descriptive reporting rather than as a definitive safety conclusion.
12. What the Result Does, and Does Not, Mean
The registry record establishes that PAGE-1 AG1 was designed as a randomized comparison of Genecept Assay-guided treatment with treatment as usual for outpatient adults described as having treatment-resistant depression. The primary question concerned baseline-adjusted change in QIDS-SR at 6 months. The record also identifies secondary areas of interest, including treatment choice, quality of life, cost, and satisfaction.
What the record does not establish is the result of the primary comparison. No group scores, change estimates, confidence intervals, p-values, or analysis details are reported. It is therefore not possible to determine from the registry whether depression-severity outcomes differed, how large any difference was, or how precisely it was estimated. This lack of posted results should not be interpreted as proof of no effect, proof of benefit, or proof of harm.
The study’s terminated status does not explain the missing analysis. The reason for termination is not reported in the registry record, and status alone does not reveal whether recruitment, follow-up, data quality, or another consideration was involved. The enrollment figure also does not establish how many participants completed follow-up or contributed to any outcome analysis.
The adverse-event figures are separate from the efficacy question. They provide limited counts in serious and other event categories, but do not include event descriptions or comparative statistical analysis. The secondary outcomes likewise do not have reported results in this record. As a result, readers can identify the intended questions and some recorded safety counts, but cannot draw a trial-based conclusion about comparative efficacy or a comprehensive safety profile.
In general, interpreting a clinical trial requires more than its design and endpoint definition. The observed outcomes, analysis population, handling of missing data, estimate of effect, and uncertainty all matter. Those elements are not reported for the primary comparison. Any conclusion about the relative outcomes of the study arms would go beyond the information in the registry record.
13. Why This Trial Matters Statistically
This study raises a statistical question about whether genetic information used to guide treatment decisions is associated with a different depression-severity outcome than treatment as usual. The design is relevant to that question because the comparison is randomized and the primary endpoint is explicitly framed as a group comparison at 6 months, with adjustment for baseline severity. The comparator also provides genetic testing while withholding the results, distinguishing the information-guided decision process from the act of providing a DNA sample.
For a trial of this kind, the usefulness of a statistical comparison depends on transparent reporting of both the outcome and the analysis. A group difference needs an estimate and a measure of uncertainty; interpretation also depends on who was analyzed, how incomplete assessments were handled, and how the primary endpoint was defined across assessments. The registry describes the intended endpoint but does not report these results or methods. That gap makes the distinction between a plausible research question and a demonstrated trial finding especially important.
The study also lists outcomes beyond symptom severity, including whether clinicians changed recorded treatment choices and how participants and clinicians assessed acceptability. These outcomes could address different aspects of an assay-guided approach, but they cannot substitute for the primary efficacy comparison, and their results are not reported in the registry record.
Statistically, the record is most useful for identifying the intended design, intervention contrast, endpoint, and reporting limitations. It cannot establish how precisely the study estimated an effect or whether its data supported a treatment difference. Recognizing that boundary prevents design features from being mistaken for findings.
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 registry record has important trial-specific reporting gaps. It identifies a primary outcome but does not provide outcome values or an analysis of the comparison. Although the endpoint is described as baseline-adjusted change in QIDS-SR at 6 months, the exact analysis method is not reported. The primary outcome population is labeled “Invalid Data Collection,” which limits clarity about the population to which the endpoint refers.
The record lists enrollment of 29 but does not report the number of participants with completed primary assessments, withdrawals, follow-up by arm, or reasons for missing measurements. It does not identify the analysis population or explain how missing data were handled. This means the enrollment figure cannot be used to infer the analyzed sample or the amount of information supporting any treatment comparison.
Other design and analysis details are also absent. The randomization procedure and allocation concealment are not reported. Although the study is labeled single-masked, the masked parties and masking procedures are unspecified. The statistical analysis plan, sample-size justification, multiplicity approach, and interim analyses are not reported in the registry record. The record also does not describe the usual-care treatments or explain how genetic assay results informed specific decisions.
The trial is recorded as terminated, but the reason is not reported. The record does not report results for the primary or secondary outcomes, and it provides limited detail about adverse events. Together, these gaps prevent a full assessment of outcome completeness, analysis choices, and the context for the recorded safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pharmacogenomics for Antidepressant Guidance and Education 1 (PAGE-1_AG1) — NCT01426516.
- Registry record last updated 2021-09-13; status last verified 2021-08.
- Results first posted 2015-11-30.
- 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
NCT01426516, Pharmacogenomics for Antidepressant Guidance and Education 1 (PAGE-1 AG1), is recorded as a randomized, single-masked, parallel-group study of Genecept Assay-guided treatment versus treatment as usual. It concerns outpatient adults with treatment-resistant depression in the context of major depressive disorder. Enrollment is listed as 29; the study status is terminated. The reason for termination is not reported in the registry record.
The primary outcome is baseline-adjusted change in QIDS-SR at 6 months. The registry lists five outcome measures, but no analyses are reported. The primary comparison’s estimate, uncertainty, analysis population, and missing-data handling are not reported. Serious adverse-event counts are recorded as 0 affected among 12 at risk in treatment as usual and 0 among 17 at risk in the Genecept Assay arm; other adverse-event counts are also listed. Deaths are not reported in the registry record.