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 Biomarkers in First Episode Schizophrenia (NCT02033382), a registered phase not stated study. The primary outcome is Biomarkers.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02033382 |
| Phase | Phase not stated |
| Condition | Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Depressed Type |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 165 |
| Arms in the primary outcome | n/a |
| Lead sponsor | NYU Langone Health |
| Results posted | Yes |
2. Clinical Question
Population
Participants diagnosed with schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type, who were naïve to antipsychotic treatment. The comparator group consisted of age- and gender-matched healthy controls. The primary outcome description refers to medication-naïve schizophrenia or schizophreniform subjects, while the patient-arm description also includes schizoaffective disorder, depressed type; the record does not clarify that difference in scope.
Intervention
This was not a randomized treatment comparison. The study description concerns biomarker and structural brain imaging assessment before and after initiation of antipsychotic medication among medication-naïve participants. The registry record does not specify a particular medication or treatment regimen.
Comparator
For the baseline biomarker comparison, the comparator was a group of age- and gender-matched healthy controls. The record does not describe these groups as randomized or otherwise establish that they are exchangeable with the patient group.
Primary question
At baseline, do measurements of biomarkers related to inflammation, BDNF, oxidative stress, glucocorticoids, and folate or methylation status differ between medication-naïve participants with early psychosis and matched healthy controls? The primary outcome is described in pg/mL, with results intended to be expressed as medians and inter-quartile ranges. Comparative estimates and tests are not reported in the registry record.
3. Trial Design
The registry record describes a study titled Biomarkers in First Episode Schizophrenia, sponsored by NYU Langone Health. It lists an enrollment of 165 and a completed status. The recorded start was 2012-07, and primary completion was 2014-12. The conditions listed are schizophrenia, schizophreniform disorder, and schizoaffective disorder, depressed type.
The study has two described groups: patients who were naïve to antipsychotic treatment and age- and gender-matched healthy controls. The record characterizes the work as evaluating biomarkers and structural brain imaging in medication-naïve subjects with early psychosis before and after antipsychotic medication initiation. It does not describe a randomized allocation, and allocation is not stated. The listed groups therefore should not be read as randomized treatment arms or as a like-for-like treatment control comparison.
The primary outcome description concerns baseline biomarkers associated with inflammation, BDNF, oxidative stress, glucocorticoids, and folate or methylation status. The stated unit is pg/mL, and the planned summary form is median with inter-quartile range. Secondary outcomes include Left Hippocampal Volumetric Integrity, Cognitive Performance, and Annualized Change in Left Hippocampal Volume Integrity. The record lists seven outcome measures overall, but does not provide the full set of result estimates or explain the timing and analysis details for every measure.
The record identifies the study as completed, but completion status alone does not establish that results were posted for each outcome. Comparative biomarker estimates and inferential analyses 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 | Healthy Controls | Patients |
|---|---|---|
| STARTED | 83 | 82 |
| COMPLETED | 32 | 36 |
| NOT COMPLETED | 51 | 46 |
Analysis population for the primary outcome, as defined in the registry: Not all biomarkers were available for analysis for all subjects.
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 | Healthy Controls | Patients | Total |
|---|---|---|---|---|
| Participants analysed | 73 | 79 | 152 | |
| Age, Continuous | years | 23.86 (SD 6.40) | 25.19 (SD 7.39) | 24.56 (SD 6.95) |
| Sex: Female, Male: Female | Participants | 40 | 40 | 80 |
| Sex: Female, Male: Male | Participants | 33 | 39 | 72 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 73 | 74 | 147 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 3 | 3 |
| Race (NIH/OMB): White | Participants | 0 | 2 | 2 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: China | participants | 73 | 79 | 152 |
6. Primary Endpoint
The registry lists the primary outcome as Biomarkers, measured over Baseline.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | pg/mL |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is a set of biomarker measurements at baseline, described in pg/mL and summarized using medians and inter-quartile ranges. The biomarkers cover inflammation, BDNF, oxidative stress, glucocorticoids, and folate or methylation status. The stated purpose is to compare medication-naïve participants with schizophrenia or schizophreniform disorder and matched healthy controls, to identify factors associated with illness.
Biomarker measurements can provide quantitative descriptions of biological characteristics. A baseline comparison can show how the distributions in two observed groups differ, if group-specific values and an analysis are reported. The median describes the central position of a distribution, while the inter-quartile range describes the spread of its middle portion. These summaries are often useful when values are skewed or include unusually high or low observations; that is a general statistical reason for using them, not a claim about the distribution in this study.
The registry record states that not all biomarkers were available for analysis for all subjects. It does not report the median or inter-quartile range for any biomarker, the number analyzed for each measure, or a comparative estimate. Consequently, the outcome definition is available, but the observed biomarker results and their precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies the study question and the groups intended for comparison, but does not report the numerical primary outcome results. No group-specific biomarker medians or inter-quartile ranges, differences between groups, confidence intervals, or p-values are reported in the registry record. As a result, the magnitude and precision of any baseline biomarker contrast cannot be evaluated from the posted results described in this record.
The enrollment is listed as 165, but that figure does not establish how many participants contributed data to each biomarker analysis. The record specifically notes that not all biomarkers were available for analysis for all subjects. The analysis population may therefore differ by biomarker; the number included for each outcome is not reported in the registry record. Without those counts and outcome estimates, readers cannot assess how much information supports a given comparison or whether missing measurements may have influenced it.
The healthy control group is described as age- and gender-matched, but the record does not explain the matching procedure or report whether the analysis accounted for matching. Nor does it state that the groups were randomized. Group differences in an observational comparison can reflect factors beyond the condition of interest, so a measured difference would not by itself establish that illness caused the biomarker pattern. In this record, even the comparative measurements themselves are absent.
The study description also refers to assessment before and after antipsychotic initiation, but the stated primary biomarker timeframe is baseline. No post-initiation biomarker estimates, change estimates, or treatment comparisons are reported in the registry record. The secondary outcome names indicate that hippocampal integrity and cognitive performance were considered, but the names alone do not show the direction or size of any findings.
For these reasons, the registry record supports describing the study purpose, design features, and outcome definitions, not drawing conclusions about biomarker differences or changes over time. A completed status is not a substitute for posted outcome data. No claim about a biomarker association, clinical effect, or treatment effect can be judged from the outcome information.
9. Statistical Methods Explained
The primary outcome is described with medians and inter-quartile ranges. These are descriptive summaries. A median marks the midpoint of ordered observations, and the inter-quartile range describes the span from the lower to the upper quartile. In general, these summaries can be informative when a measurement distribution is asymmetric or has extreme observations. They do not, by themselves, quantify the uncertainty in a group comparison or show whether an observed contrast could plausibly reflect sampling variation.
A comparative analysis would ordinarily need to specify how the groups are contrasted and how uncertainty is expressed. For example, an estimate of a difference between groups could be accompanied by a confidence interval. In general, a confidence interval describes a range of values compatible with the data and the assumptions of the analysis; a narrower interval indicates greater precision, while a wider interval indicates less precision. No comparative estimate or confidence interval is reported in the registry record for the primary outcome.
A p-value is a measure defined relative to a statistical model and a null hypothesis. It is not an effect size and does not describe the probability that the null hypothesis is true. Interpretation also depends on the analysis plan, the outcome definition, and the set of comparisons considered. No p-values or test methods for the biomarker comparisons are reported in the registry record. It is therefore not possible to tell whether the posted analysis used a parametric test, a rank-based procedure, a regression model, or another approach.
What can be inferred from the summaries?
If medians and inter-quartile ranges were available for both groups, they would describe each group’s central location and middle spread. Those summaries alone would not establish that the groups differ statistically, nor would they adjust for other characteristics. The registry record does not provide these values, so no observed distributional contrast can be characterized.
How should the group structure be understood?
The design describes patients and matched healthy controls, not randomized treatment groups. Matching may help make groups more comparable on the matched characteristics, but the record does not detail how matching was carried out or whether it was incorporated into analysis. In general, if matching creates linked pairs or sets, an analysis that ignores that structure may not reflect the design. Whether that issue applies to the actual analysis cannot be determined from the record.
More generally, observational group comparisons can be affected by confounding: characteristics related both to group membership and to the biomarker may contribute to an apparent contrast. Matching on age and gender does not establish balance on unreported factors. The record does not report adjusted analyses or enough detail to assess residual confounding. This is a general caution about the design, not evidence that a particular bias occurred.
What does missingness mean for these outcomes?
The record states that not all biomarkers were available for analysis for all subjects. In general, the amount and pattern of missing data matter because analyses may have different available participants, and missingness can reduce precision. If the probability of a measurement being unavailable is related to participant characteristics or the unobserved value, a complete-case comparison may also be biased. The record does not report biomarker-specific counts, reasons for missingness, or methods for handling it, so the extent or direction of any impact cannot be assessed.
The record lists seven outcome measures and zero analyses. This means the registry entry does not include reported analysis records for the listed outcomes. The statistical tests, model specifications, covariate adjustments, confidence intervals, and handling of multiple comparisons are not reported in the registry record. Those details should not be inferred from the outcome names or from the choice to report medians and inter-quartile ranges.
The record also includes planning assumptions for illustrations based on an observed effect: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. For time-to-event illustrations, the stated quantity is total events; for other illustrations, it is participants per arm. These are planning assumptions, not evidence about the trial’s original design or observed power. The registry record does not report a protocol-based sample-size justification. Without posted outcome estimates and the numerical planning results, no specific planning conclusion can be drawn.
10. Multiplicity, Missing Data and Analysis Populations
The study lists a primary biomarker outcome spanning several biological domains, three named secondary outcomes, and seven outcome measures overall. Considering multiple biomarkers and outcomes creates a general multiplicity issue: when many hypotheses are examined, the chance of at least one apparently notable result can increase if each is interpreted without accounting for the family of comparisons. Whether the study used a prespecified hierarchy, adjusted significance thresholds, or another multiplicity strategy is not reported in the registry record.
The record lists zero analyses and does not give outcome-level estimates, test results, or an analysis plan. It is therefore not possible to identify which comparisons were performed, whether all planned outcomes were reported, or how any multiplicity was handled. The existence of several outcome measures does not establish that the results were selectively reported, but the available record does not allow that question to be assessed.
Missing biomarker data are explicitly noted: not all biomarkers were available for analysis for all subjects. The record does not report the number of participants analyzed for each biomarker, the reasons measurements were unavailable, or whether missingness was addressed using complete-case analysis, imputation, or another method. In general, differing analysis populations can affect both precision and comparability across biomarkers. The direction of any effect cannot be inferred without information about who had missing measurements and why.
Patient and control group counts for individual biomarker analyses, the handling of matched groups, and definitions of the analysis populations are not reported in the registry record. These omissions limit interpretation of both the coverage of the data and the validity of statistical inferences.
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 |
|---|---|---|---|
| Healthy Controls | 0 | 73 | 0.0% |
| Patients | 0 | 79 | 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 |
|---|---|
| Healthy Controls | 0 of 73 |
| Patients | 1 of 79 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Healthy Controls | Patients |
|---|---|---|---|
| Blurred Vision | Eye disorders | 0 of 73 | 1 of 79 |
| Hypertension | Cardiac disorders | 0 of 73 | 1 of 79 |
The registry record lists serious adverse events as affecting zero participants in Healthy Controls, with 73 at risk, and zero participants in Patients, with 79 at risk. For other adverse events, it lists zero affected among 73 at risk in Healthy Controls and one affected among 79 at risk in Patients. These are counts recorded for the groups, not comparative risk estimates.
The record does not provide event descriptions for the single other adverse event, and no top serious adverse-event terms are listed. Deaths are recorded as null for both groups; the registry record therefore does not report death counts. It also does not describe the monitoring period, event collection procedures, or whether adverse-event reporting covered every participant and study phase.
These figures should be interpreted as the safety entries in the registry, not as a complete assessment of all possible harms or as evidence about a treatment effect. The study is not described as a randomized treatment comparison, and the group labels refer to patients and healthy controls. The registry record does not provide enough detail to compare safety between treatments or to attribute an event to antipsychotic medication.
12. What the Result Does, and Does Not, Mean
The registry record identifies an investigation of biomarkers and structural brain imaging in medication-naïve subjects with early psychosis, including a baseline comparison with matched healthy controls. It specifies biomarker domains, measurement units, and descriptive summaries, and it names secondary measures involving hippocampal integrity and cognitive performance. These details help define the scientific question the study was intended to address.
However, the record does not report the primary biomarker values, group comparisons, uncertainty estimates, or statistical test results. It therefore does not establish whether any listed biomarker was higher, lower, or similar between groups, nor how precisely such a comparison was estimated. It also does not report change estimates after antipsychotic initiation. The absence of posted results in the registry record is not evidence that no differences or changes occurred.
The groups were not described as randomized, and the registry does not state how allocation occurred. Any observed patient-control contrast, if reported elsewhere, would need to be interpreted in light of the observational group structure and potential differences between groups. Matching on age and gender is noted, but additional design and analysis details are not reported.
The outcome availability note also matters: not all biomarkers were available for analysis for all subjects. Without outcome-specific counts and missing-data methods, readers cannot determine the coverage or representativeness of each analysis. The listed safety counts are limited registry entries and do not supply detailed event descriptions or treatment-attribution information.
Thus, the record supports a description of the study’s aims, groups, and planned outcome summaries, but not a conclusion about biomarker findings, clinical meaning, or the effects of medication. Such conclusions require outcome results and analysis details that are not reported in the registry record.
13. Why This Trial Matters Statistically
This study illustrates a recurring distinction in clinical research between a well-defined biological question and a result that can be statistically evaluated. The registry record identifies candidate biomarker domains, a baseline comparison, and an intended summary format. Those specifications communicate what was to be measured, but they do not reveal the observed distributions or the uncertainty around comparisons.
The design also highlights why group structure matters. Patients and age- and gender-matched healthy controls can be useful for describing differences between groups, but the comparison is not randomized. Statistical adjustment and matching details are relevant because measured group contrasts may reflect characteristics other than the illness under study. The registry record does not give enough information to evaluate those issues in the analyses.
Outcome completeness is another central statistical concern. The record notes that not all biomarkers were available for analysis for all subjects. Biomarker-specific sample counts and explanations of missingness would help readers judge the information behind each estimate and whether missing measurements could affect interpretation. Such details are not reported in the registry record.
Finally, the record includes multiple outcome measures but no analysis records or comparative results. This makes it impossible to assess multiplicity, model choices, or precision. The study matters statistically as an example of why outcome definitions, analysis populations, missing-data handling, and uncertainty estimates are all needed alongside a study’s aims and completion status. Without the results and methods, the scientific question can be described, but its empirical answer cannot be assessed.
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.
A central limitation of the registry record is that it does not report the primary biomarker results. There are no group-specific medians or inter-quartile ranges, comparative estimates, confidence intervals, or test results. The stated outcome and its measurement unit are not enough to assess the size, direction, or precision of a difference.
The record notes that not all biomarkers were available for analysis for all subjects, but gives no biomarker-specific analysis counts, reasons for missing measurements, or missing-data methods. The enrollment figure of 165 does not show how many participants contributed to any particular outcome. This prevents assessment of the amount of information available for individual comparisons.
The group descriptions also leave important design details unresolved. The patients and healthy controls are described as matched on age and gender, but the matching process and its treatment in analysis are not reported. Allocation is not stated, and the study is not described as randomized. The record does not specify a particular antipsychotic medication, treatment regimen, or detailed timing for the before-and-after assessments.
The primary outcome description refers to schizophrenia or schizophreniform subjects, while the patient-arm description also includes schizoaffective disorder, depressed type. The record does not explain whether that difference reflects distinct analysis populations or different wording. It also lists seven outcome measures but does not report the full analysis plan or how multiple outcomes were handled. These are limitations of what can be interpreted from the registry record, rather than evidence that the underlying study lacked those procedures.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Biomarkers in First Episode Schizophrenia — NCT02033382.
- Registry record last updated 2021-01-14; status last verified 2021-01.
- Results first posted 2021-01-14.
- 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
Biomarkers in First Episode Schizophrenia is a completed study sponsored by NYU Langone Health, with enrollment listed as 165. The recorded study start was 2012-07, and primary completion was 2014-12. The registry describes medication-naïve patients with schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type, and age- and gender-matched healthy controls.
The primary outcome concerns baseline biomarkers related to inflammation, BDNF, oxidative stress, glucocorticoids, and folate or methylation status. It specifies pg/mL and median with inter-quartile range. Secondary outcomes include left hippocampal volumetric integrity, cognitive performance, and annualized change in left hippocampal volume integrity. The record notes that not all biomarkers were available for analysis for all subjects.
Comparative outcome results and statistical analyses are not reported in the registry record. The study is not described as randomized, and allocation is not stated.