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 Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects (NCT06787781), a na na study. The primary outcome is Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06787781 |
| Phase | NA |
| Condition | Metabolic Evaluation, Cardiac Complications |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 15 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Messina |
| Results posted | Yes |
2. Clinical Question
Population
People with schizophrenia who were described as being on stable therapy with atypical antipsychotics. The registry record reports enrollment of 15 participants. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
Alpha-lipoic acid (ALA). The registry record identifies the intervention but does not report the administered dose, dosing schedule, adherence, or whether every enrolled participant received treatment as planned.
Comparator
There was no concurrent control group. The study is described as open-label and uncontrolled, with a single group. Participants therefore were not compared with a randomized placebo or usual-care group in this record.
Primary question
How did blood measures related to lipid and carbohydrate metabolism change from enrollment to week 12 during ALA treatment? The stated measures include total cholesterol, HDL, LDL, triglycerides, and glucose. The registry record also describes safety and potential clinical effects as study aims.
The clinical question is about metabolic measurements over time in a treated group, not a comparison of treatment effects between groups. The listed primary outcome is assessed from enrollment to the end of treatment, with week 12 reported. A secondary outcome concerns changes in total score on the Positive and Negative Syndrome Scale (PANSS). The record does not report results for either the metabolic measures or the PANSS outcome, so it does not show the size or direction of any observed change.
Because the study has no control group, a change between enrollment and week 12 would describe what happened during follow-up among the participants assessed. On its own, such a change would not separate the effect of ALA from other explanations, such as changes over time or concurrent care. The registry record does not report details of concurrent treatments or other factors that could help interpret change.
3. Trial Design
The registry record describes a completed, single-group study with open-label treatment and no control group. It lists an enrollment of 15 and a treatment period of 12 weeks. The study title and summary identify participants with schizophrenia who were stable on atypical antipsychotics. ALA is the listed intervention. The design does not include a randomized comparison, so the group serves as its own reference over time rather than being compared with a separate untreated or control group.
Open-label means the study was not masked: the registry record lists masking as none. In general, lack of masking can affect expectations, reporting, care decisions, and assessment, depending on the outcome and study procedures. The record does not describe who measured the blood parameters, how measurements were obtained, or whether outcome assessors were independent.
The primary outcome is framed as an assessment from enrollment to the end of treatment, with week 12 reported. The described blood measures are total cholesterol, HDL, LDL, triglycerides, and glucose, expressed under a common unit of mg/dl in the outcome record. The record also lists a secondary PANSS total-score change outcome. It reports eight outcome measures, but the details and results for those measures are not present in the information available in the registry record.
Allocation is listed as not applicable, consistent with the absence of a randomized arm allocation in this single-group design. The study phase is not reported in the registry record. The statistical analysis plan, including the intended tests, adjustment strategy, treatment of repeated measurements, and handling of missing observations, is not reported in the registry record. The record also does not report a sample-size justification. The enrollment count alone cannot establish whether the study was designed to estimate a particular effect with a stated precision.
The study is marked completed, but completion status does not itself provide evidence about the outcomes. The record lists no analysis entries. Thus the design and intended assessments can be described, but the registry record does not provide the numerical endpoint findings needed to characterize observed metabolic or clinical changes.
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: Patients who met DSM-5 criteria for schizophrenia, aged between 18 and 60 years old in stable atypical antipsychotic monotherapy (clozapine, olanza- pine, quetiapine, or risperidone) for least 3 months.
Overall Study
| Stage | AlphaLipoicAcid Group |
|---|---|
| STARTED | 15 |
| COMPLETED | 15 |
| NOT COMPLETED | 0 |
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 | AlphaLipoidAcid Group |
|---|---|---|
| Participants analysed | 15 | |
| Age, Continuous | years | 44.60 (SD 11.16) |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 11 |
| Race/Ethnicity, Customized: White | Participants | 15 |
| Region of Enrollment: Italy | Participants | 15 |
| Body weight | kg | 95.80 (SD 19.13) |
| Body massindex | kg/m2 | 32.18 (SD 5.99) |
| Systolic blood pressure | mmHg | 137 (SD 22.01) |
| Diastolic blood pressure | mmHg | 82 (SD 15.49) |
| Qtc | msec | 422.80 (SD 17.11) |
| Triglycerides | mg/dl | 110.60 (SD 57.01) |
| total cholesterol | mg/dl | 177.20 (SD 39.62) |
| HDL | mg/dl | 38.8 (SD 6.74) |
| LDL | mg/dl | 108.80 (SD 33.93) |
| Glucose | mg/dl | 105.40 (SD 14.05) |
6. Primary Endpoint
The registry lists the primary outcome as Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework, measured over Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mg/dl |
| Endpoint classification | Continuous Endpoint |
The primary endpoint concerns blood parameters related to lipid and carbohydrate metabolism. The listed measures are total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides, and glucose. The registry record describes them as continuous measurements, reported as means with standard deviations, and gives mg/dl as the unit. The assessment is framed as change from enrollment through the end of treatment, with week 12 reported.
These measures are used to describe aspects of metabolic status. In a study involving people taking atypical antipsychotics, assessing them can address the stated research question about metabolic factors during ALA administration. This is the rationale implicit in the study aim; it does not establish that any particular measure improved or worsened. The registry record gives no actual baseline or week-12 values, no change estimates, and no uncertainty intervals for the primary measures.
A mean describes the average value in the assessed group, while a standard deviation describes the spread of participant measurements around that mean. These summaries can help characterize the group, but they do not show how precisely a mean or a change has been estimated. Precision would usually be conveyed with an appropriate confidence interval or other uncertainty estimate; such estimates are not reported in the registry record.
The record also lists total PANSS score change as a secondary outcome. The primary metabolic endpoint and this clinical scale address different kinds of outcomes. The available registry information does not report their numerical results, details of the measurement procedures, or the analysis used to compare enrollment with week 12.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the study question, design, enrollment, intervention, and planned outcome measures, but it does not report numerical results for the primary metabolic outcomes. It therefore does not establish the observed direction, magnitude, or precision of changes in total cholesterol, HDL, LDL, triglycerides, or glucose. No baseline values, week-12 values, change estimates, confidence intervals, or p-values are reported in the registry record. The same limitation applies to the listed PANSS total-score change outcome.
For the design described, the most direct result would be a within-group description of measurements at enrollment and week 12. If measurements changed, that would document a temporal pattern in the participants assessed. It would not, by itself, estimate what would have happened over the same period without ALA. Without a concurrent comparison group, treatment effects cannot be distinguished from time trends, changes in other care, regression to the mean, measurement variability, or other influences. These are general interpretive considerations, not reported events in this study.
The open-label design is another consideration. General methodological reasoning is that knowledge of treatment can influence some outcomes through expectations or assessment practices. Laboratory measurements are more objective than many subjective outcomes, but their collection, handling, and analysis still require suitable procedures. The registry record does not report those procedures, so their role in this study cannot be assessed from the record.
The enrollment of 15 describes the number entered in the study, not necessarily the number contributing to every endpoint. The number assessed at week 12, the extent of missing outcome data, and the analysis population are not reported in the registry record. As a result, the completeness of follow-up and the representativeness of any endpoint summaries cannot be evaluated.
There are also no reported numerical findings with which to judge how precisely any change was estimated. General statistical interpretation distinguishes the estimated change from its uncertainty: a confidence interval would indicate a range of values compatible with the data under the analysis assumptions. No such interval is reported in the registry record. A p-value, even if available, would not substitute for the magnitude and precision of an estimate; no p-values are reported either.
The study background describes earlier investigations of ALA, but those descriptions do not supply results for this study. They cannot be used to fill in its missing outcome data. The record’s status as completed likewise does not imply that a beneficial, harmful, or null result was observed. The defensible conclusion is limited to the design and objectives: a small, uncontrolled group was followed during a 12-week intervention, while outcome findings are not reported in the registry record.
9. Statistical Methods Explained
The registry record describes continuous outcomes summarized as means and standard deviations. It does not identify the statistical tests or models used. The explanations below are general statistical guidance for understanding this type of outcome and do not describe confirmed procedures from this study.
What does a mean describe?
A mean is the arithmetic average of measured values in a group. For a continuous endpoint such as a blood concentration, it gives a compact description of the group’s central level. A mean can be affected by unusually high or low observations, so its interpretation is strongest when considered alongside the distribution of the measurements and other summaries. The registry record does not report individual measurements or distributional details.
The standard deviation describes how dispersed individual measurements are around the group mean. It is a measure of variability among observations, not a measure of uncertainty in the estimated mean and not a confidence interval. A larger standard deviation indicates greater spread in the observed values, but it does not by itself establish whether a change over time is important or precisely estimated.
How should change over time be understood?
For a repeated-measures question, the relevant quantity is usually the difference between measurements taken from the same participants at different times. General statistical methods can account for the pairing of observations, because measurements from one person are often related. A method that treats measurements as independent when they are paired may not represent that relationship appropriately. The registry record does not report whether the analysis used paired comparisons, a repeated-measures model, or another method.
The record frames the primary assessment as running from enrollment to week 12. That wording describes the intended time span but does not specify how all intermediate or incomplete observations were handled. If some participants did not have both measurements, the analysis method and missing-data assumptions would matter. Those details are not reported in the registry record.
What does a confidence interval add?
In general, a confidence interval communicates the uncertainty around an estimated quantity, such as a mean change. It helps readers judge which effect sizes are reasonably compatible with the observed data under the method’s assumptions. A narrow interval indicates greater statistical precision than a wide interval, while neither width nor location alone answers whether a change matters clinically. The registry record does not report confidence intervals for the listed outcomes.
A p-value, in general, measures how unusual the data would be under a specified null hypothesis and statistical model. It does not give the probability that the null hypothesis is true, and it does not convey the size of an effect. Interpretation should consider the estimate and its uncertainty rather than rely on a significance threshold alone. The registry record does not report p-values or the tests from which they might arise.
Why does the absence of a control group matter?
In general, a concurrent control group helps distinguish changes associated with an intervention from changes that might occur over time for other reasons. A single-group before-and-after design can describe observed change, but it cannot provide the same controlled contrast. Participants may change for reasons unrelated to the intervention, and selection based on an initially unusual measurement can be followed by a value closer to the person’s usual level. This general phenomenon is called regression to the mean. The record does not report whether such issues arose; they are design considerations rather than study findings.
Open-label conduct also has general implications. When treatment is known, expectations and measurement practices may influence some outcomes. Laboratory endpoints are less subjective than symptom ratings, but reliable interpretation still depends on consistent collection and assessment. The registry record does not state the laboratory procedures, assessor arrangements, or safeguards against measurement bias.
What can the sample size say?
The enrollment count is 15. A sample-size justification and a target precision are not reported in the registry record. General sample-size calculations depend on the planned comparison, expected variability, target effect, error rates, and analysis method. A calculation based on an observed effect is a planning illustration, not evidence of power actually achieved by a completed study. It also cannot replace reporting the observed estimate and its uncertainty. No numerical outcome estimates are reported in the registry record from which to judge precision.
In general, over-dispersion means that observed variability is greater than a model assumes. If ignored, it can make standard errors too small and uncertainty look less than it is. Whether over-dispersion is relevant depends on the outcome and model; it is not established for these continuous measures by the registry description. The analysis model and diagnostic checks are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary metabolic outcome description, a secondary PANSS outcome, and eight outcome measures overall. It does not report the full set of outcome definitions, a prespecified hierarchy among outcomes, or a plan for controlling multiplicity. In general, testing many outcomes can increase the chance of at least one apparently notable result arising by chance. Methods such as prespecifying a primary outcome, adjusting inference, or treating secondary findings as exploratory can address different aspects of this issue. Which, if any, approach was used is not reported in the registry record.
The record reports no analysis entries and gives no numerical outcome findings. It also does not report whether analyses were prespecified, whether any analyses were exploratory, or whether there were interim analyses. Those details should not be inferred from the completed status or the number of listed measures.
Missing-data handling is not reported in the registry record. The enrolled count does not establish how many participants contributed measurements at each time point or to each outcome. The record does not state whether missing observations occurred, why they may have occurred, or whether an analysis used complete cases, imputation, or a model that used available repeated observations. These approaches rely on different assumptions, so the number and pattern of missing observations and the chosen method can affect interpretation.
The analysis population is likewise not reported in the registry record. It is not stated whether analyses included everyone enrolled, only participants who completed treatment, or another defined group. Without these details and endpoint-specific participant counts, it is not possible to assess attrition, analysis-population selection, or the potential influence of missing data on the reported findings.
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 |
|---|---|---|---|
| Alpha Lipoic Acid | 0 | 15 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Alpha Lipoic Acid | 0 of 15 |
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 |
|---|---|
| Alpha Lipoic Acid | 0 of 15 |
The registry record lists 15 participants at risk in the ALA group. It reports 0 participants with serious adverse events, 0 with other adverse events, and 0 deaths. No serious adverse-event terms are listed. These figures describe the events recorded in the registry entry; they do not provide a detailed event-by-event account or explain how events were monitored and classified.
A count of zero means that no affected participants were recorded in the specified category in this entry. It does not prove that no event occurred, that every possible harm was ruled out, or that the intervention is safe in other settings. General interpretation of safety counts depends on the duration of observation, completeness of follow-up, event definitions, and reporting practices. The registry record does not provide further detail on these points.
The study followed a single group for 12 weeks, and the record does not report a comparator safety rate. Thus the listed counts cannot support a comparative estimate of event risk. They also do not indicate the severity or nature of events beyond the distinction between serious and other events. The counts should be read as registry-reported observations, not as a comprehensive safety evaluation.
12. What the Result Does, and Does Not, Mean
The study addresses a relevant statistical question: whether metabolic measures changed during ALA administration among people with schizophrenia receiving stable atypical antipsychotic therapy. The registry record describes an open-label, uncontrolled, single-group study with 15 enrolled participants and a 12-week assessment period. It lists metabolic measures as the primary outcome and PANSS total-score change as a secondary outcome.
What the record does not show is the result of those assessments. Numerical baseline and week-12 measurements, changes, uncertainty intervals, and p-values are not reported in the registry record. Therefore, the direction and size of any metabolic or clinical changes cannot be stated from this entry. The reported safety counts are zero for serious adverse events, other adverse events, and deaths among the listed participants at risk, but these counts do not settle broader safety questions.
Even if within-group changes were available, the uncontrolled design would limit causal interpretation. General statistical reasoning is that the change observed over time may reflect the intervention, other changes in care, natural variation, measurement factors, or a combination. A control group would allow a more direct comparison of changes under different treatment conditions, but this study did not include one.
The record can therefore support a description of the study’s intended question and design, not a claim about whether ALA caused a change or how large or precise that change was. It does not establish benefit, lack of benefit, or harm. It also does not provide enough information to evaluate the analysis plan, missing data, or precision of outcome estimates. These distinctions are important: a completed study and a stated objective are not substitutes for posted outcome results.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the difference between a research question and evidence that can answer it. The registry record identifies metabolic measures, a defined follow-up period, and a clinical population, but it does not report the numerical findings. Without estimates and uncertainty, readers cannot judge the magnitude, direction, or precision of the outcomes being studied.
The single-group design makes the distinction between observed change and causal effect especially important. In general, before-and-after measurements can describe a trajectory among participants, but they do not show what the same participants would have experienced under a different treatment condition. That missing comparison limits attribution, even when measurements are collected consistently.
The enrollment of 15 also highlights why study size and statistical precision are related but not interchangeable. A sample size alone does not reveal the range of plausible effects. That requires outcome estimates and uncertainty measures, interpreted with the analysis method and data completeness. The registry record does not report those results or a sample-size justification.
Finally, the record illustrates the value of complete reporting. Clear outcome definitions, participant counts at each assessment, analysis populations, methods for repeated measurements, missing-data procedures, and uncertainty estimates would help readers evaluate what the study found. These details are not reported in the registry record. The study’s stated aims remain clinically relevant, but the available information supports interpretation of its design rather than its efficacy or safety conclusions.
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 key limitation for interpreting this trial is that the registry record does not report numerical outcome results. There are no baseline or week-12 values, change estimates, confidence intervals, or p-values for the metabolic measures or PANSS outcome. As a result, the observed findings and their precision cannot be described.
The design is single-group, open-label, and uncontrolled. It cannot separate change during follow-up from change attributable to ALA. The registry record also does not report the dose or dosing schedule, treatment adherence, detailed eligibility criteria, participant characteristics, or concurrent care. These omissions restrict assessment of treatment exposure and the population to which any results might apply.
Although enrollment is 15, endpoint-specific numbers assessed and the analysis population are not reported in the registry record. The record does not describe missing-data patterns or methods, the statistical tests or models, multiplicity handling, or a sample-size justification. It also does not provide details about laboratory measurement procedures or outcome assessment. These gaps limit evaluation of bias, precision, and reproducibility.
Finally, the listed safety counts are brief aggregate counts without event descriptions or additional monitoring details. They cannot provide a full account of adverse events or comparative safety. These limitations concern what can be interpreted from the registry record; they do not establish that a particular problem occurred in the study.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects — NCT06787781.
- Registry record last updated 2025-03-27; status last verified 2025-03.
- Results first posted 2025-03-27.
- 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
The registry record describes a completed, 12-week, open-label, uncontrolled study of ALA in people with schizophrenia receiving stable atypical antipsychotic therapy. It lists enrollment of 15 and identifies metabolic blood measures as the primary outcome, with PANSS total-score change as a secondary outcome.
The record reports no numerical outcome results or analysis entries. It lists 0 serious adverse events, 0 other adverse events, and 0 deaths among 15 participants at risk. Statistical methods, missing-data handling, analysis populations, and a sample-size justification are not reported in the registry record. The design permits description of change within the treated group, but does not provide a concurrent comparison for attributing changes to ALA.