A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome (NCT00508157), a randomized phase 4 study. The primary outcome is Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16.

2. Clinical Question

The endpoint focused on a metabolic measure in a population selected for both schizophrenia and metabolic syndrome. The registry describes a 16-week comparison and identifies non-HDL cholesterol as fasting total cholesterol minus fasting HDL cholesterol. The contrast is between assignment to switch to aripiprazole and assignment to remain on the pre-enrollment atypical antipsychotic; it is not a comparison between aripiprazole and one single named control drug.

The primary result is a group-level comparison. It does not describe how every participant's cholesterol changed, nor does it by itself establish what caused any individual change. Other measured outcomes addressed metabolic status, lipids, glucose, weight, body mass index, clinical severity, well-being, and quality of life. The registry record does not report a broader primary question about those outcomes.

3. Trial Design

This was a Phase 4, randomized, parallel-group, open-label study sponsored by Bristol-Myers Squibb. The registry lists schizophrenia and metabolic syndrome as conditions. The stated study duration was 16 weeks. The record gives a start date of 2007-11 and a primary completion date of 2009-03, and lists the study status as terminated.

Participants were assigned either to aripiprazole or to continued treatment with the same atypical antipsychotic used before enrollment. The aripiprazole regimen allowed flexible dosing from 10 to 30 mg once daily. The control treatment could be risperidone, quetiapine, or olanzapine. Because the study was open-label, masking was not used. Randomization was reported, but the registry record does not report the sequence-generation method, concealment procedures, or details of stratification.

The brief summary describes an intention to randomize 258 patients. The enrollment field records 125. The primary outcome analysis lists 26 participants in the control group and 25 in the aripiprazole group. The registry record does not explain the difference between the planned figure in the summary and recorded enrollment, nor does it report why the study was terminated. It also does not report the original sample-size justification or the specific operational rules used to stop enrollment.

The primary endpoint was mean percent change from baseline in fasting non-HDL cholesterol at Week 16. The posted primary analysis used a last observation carried forward data set and excluded non-HDL measurements taken after the start of lipid-lowering treatment, using the last earlier measurement for the stated LOCF analysis. Additional outcomes covered metabolic syndrome status and several metabolic and patient-reported measures. The registry lists nine outcome measures, with eight secondary outcomes.

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: 125 participants were enrolled in this study; 73 were considered baseline failures and were not randomized.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Last Observation Carried Forward (LOCF) data set, Non-HDL measurements obtained after start of a treatment with a lipid-lowering agent were excluded; last measurement prior was used for LOCF analyses. Baseline data was carried forward for LOCF analysis for subjects for whom no on-treatment measurements for fasting non-HDL cholesterol was available.

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 Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16, measured over Baseline, Week 16.

The primary endpoint was mean percent change from baseline in fasting non-HDL cholesterol at Week 16. Non-HDL cholesterol was defined in the registry as fasting total cholesterol minus fasting HDL cholesterol. The endpoint therefore describes relative change in a fasting lipid measure over the study period, rather than a final cholesterol value alone. A negative mean percent change indicates a decrease relative to baseline; a positive mean percent change indicates an increase.

Non-HDL cholesterol captures cholesterol carried in particles other than HDL. In a trial focused on metabolic syndrome, a lipid measure is relevant to the metabolic profile under study. That explains the endpoint's subject matter, but the registry record does not report a specific rationale for selecting this measure as primary or describe any threshold for a clinically important change.

The reported group means were 10.06 in the control group and -2.3 in the aripiprazole group. The posted primary analysis used an LOCF data set, excluded measurements after lipid-lowering treatment began, and used the last earlier measurement for its LOCF analyses. The record also states that baseline data were carried forward for participants for whom no on-treatment measure was available, although the registry text describing this rule is truncated. These analysis choices affect how the endpoint summarizes participants with incomplete follow-up or subsequent lipid-lowering treatment, and should be kept in mind when interpreting the group comparison.

7. Results Posted in the Registry

• Aripiprazole: mean -2.30 versus 10.06 on control; difference -12.36 (95% CI -23.75 to -0.97), standardized effect d = -0.59; z-test p = 0.033.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Number of Participants Remaining on Metabolic Syndrome at Week 16

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Aripiprazole: 64.0% (16/25) versus 84.6% (22/26) on control; risk difference -20.6 percentage points (95% CI -44.0 to 2.8), risk ratio 0.76 (0.54–1.06); unadjusted two-proportion z-test p = 0.091.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Aripiprazole and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists eight secondary outcomes spanning metabolic syndrome status, lipid parameters, fasting glucose, body weight, body mass index, clinical severity, subjective well-being, and weight-related quality of life. The posted outcome set therefore covers both metabolic measures and patient-reported or clinical measures alongside the primary lipid endpoint.

The available secondary results should be read as complementary to, not interchangeable with, the primary result. They address distinct outcomes, time points, and measurement scales, and do not automatically confirm or contradict the primary comparison. The registry record does not report individual results for the other secondary outcomes in the listed set, so an overall direction across all secondary measures cannot be established from the available results.

One secondary outcome reports the number of participants remaining on metabolic syndrome at Week 16. The reported group counts and its comparison are available in the posted results, but that outcome is not a substitute for the primary continuous cholesterol measure. Its result should be interpreted on its own scale and with its own uncertainty.

Unadjusted secondary results generally carry less weight when many outcomes are examined because the chance of at least one apparently notable result can increase as the number of comparisons grows. General explanation: multiplicity procedures can control this issue, but they may also change how estimates and evidence are interpreted. The registry record does not report a multiplicity adjustment plan or establish which secondary analyses, if any, were prespecified as confirmatory. Accordingly, secondary findings are best treated as supportive or exploratory rather than as a set of independent confirmations of the primary result.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Number of Participants Remaining on Metabolic Syndrome at Week 16
• Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16
• Mean Change From Baseline for Fasting Glucose Levels Through Week 16
• Mean Change From Baseline in Body Weight Through Week 16
• Median Change From Baseline in Body Mass Index (BMI) Through Week 16
• Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Through Week 16
• Mean Change From Baseline in Subjective Well-Being Under Neuroleptics Scale (SWN-short Form) Through Week 16
• Mean Change From Baseline in the Impact of Weight on Quality of Life (IWQoL-Lite) Scale Through Week 16

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it is a numerical measure that can take a range of values rather than only categories such as yes or no. The endpoint is mean percent change in fasting non-HDL cholesterol from baseline to Week 16. The group means describe the average change in each assigned group; they do not imply that each participant had a change equal to that mean.

What does the mean difference represent?

The mean difference compares the average endpoint in one group with the average in the other. In the sponsor-reported ANCOVA, the estimated mean difference was -11.28. Its negative direction indicates that the estimated endpoint was lower in the aripiprazole group than in control, according to the contrast as reported. The precise interpretation of an adjusted contrast depends on the model and how the comparison was parameterized; the registry names ANCOVA but does not give the full model specification or covariates.

A recalculation based on the posted group summaries gives an unadjusted mean difference of -12.36. This is not the same as the sponsor's adjusted analysis. An unadjusted comparison uses the summary values without adjustment for covariates, while ANCOVA generally estimates a group contrast while accounting for specified covariates. The covariates used in the sponsor's model are not reported in the registry record, so the adjusted estimate cannot be independently reconstructed from the available description.

Why is a confidence interval useful?

A confidence interval gives a range of values compatible with the data and the analysis procedure, and communicates uncertainty around an estimate. It is not a guarantee that the true effect lies within the particular interval, nor does it indicate that all values in the interval are equally plausible. The sponsor-reported 95% interval for the mean difference runs from -19.14 to -2.66. Since zero is not within these reported limits, the interval is consistent with a negative group contrast under that analysis. The interval's width also matters: it shows that the estimate is not known with exact precision.

What does the unadjusted recalculation add?

The simple recalculation offers a check based on the posted means and standard errors. Its estimated difference is -12.36, and its unadjusted p-value is 0.033. This is an unadjusted result, not a replacement for the registry's ANCOVA. The registry does not report a p-value for its ANCOVA result. Because the recalculation and reported analysis may differ in adjustment and assumptions, their estimates and intervals need not match exactly. The registry's own analysis remains the relevant sponsor-reported analysis.

Why can over-dispersion matter?

General explanation: over-dispersion occurs when observed variability is greater than a statistical model expects. If a model assumes less variability than the data contain, standard errors can be too small and intervals can be too narrow. Appropriate variance estimates help represent uncertainty. The registry reports standard errors for the group means but does not describe an over-dispersion assessment or a specific variance correction. This concept is therefore general context, not a claim about what occurred in this trial.

What does randomization contribute?

General explanation: random assignment is intended to make treatment groups comparable, on average, with respect to both measured and unmeasured baseline characteristics. It supports interpretation of between-group contrasts, but does not guarantee identical groups in a finite trial. The registry identifies the study as randomized but does not report its sequence-generation or allocation-concealment details. Open-label assignment also means participants and study personnel were not masked to treatment assignment. That may matter for aspects of care, measurement, or reporting, although the registry record does not establish that such influences occurred.

How does LOCF affect the analysis?

LOCF means carrying a participant's last recorded observation forward to represent a later time point when a later measurement is unavailable. The primary outcome population is described as an LOCF data set. The record further says that measurements after starting lipid-lowering treatment were excluded and the last prior measurement was used for LOCF analyses. It also notes baseline values carried forward for participants without an on-treatment measurement, but the description is truncated. LOCF is an analysis convention, not an observed Week 16 measurement for every participant. It can affect estimates when missingness or treatment changes are related to outcome values. The registry does not report sensitivity analyses comparing LOCF with other missing-data approaches.

11. Confidence Intervals and Precision

The sponsor-reported mean difference was -11.28, with a 95% confidence interval from -19.14 to -2.66. This interval describes uncertainty in the estimated group contrast under the reported ANCOVA. Its limits are both negative, so the interval does not include a zero difference. That statement is about the statistical interval, not about clinical importance or certainty for each participant.

The interval spans a range of possible magnitudes, rather than identifying a single exact value. The point estimate is the central estimate from the analysis; the lower and upper limits describe uncertainty around it. A narrower interval would indicate greater precision, while a wider interval would indicate less precision, all else being equal. The registry does not state a threshold for a clinically meaningful change in non-HDL cholesterol, so precision cannot be translated into a judgment about clinical importance from these data alone.

The unadjusted recalculation has a 95% confidence interval from -23.75 to an upper limit below zero. Its limits differ from those of the sponsor's ANCOVA, reflecting the fact that they come from a separate unadjusted calculation. The sponsor's reported estimate and interval are the appropriate reference for the trial's own analysis; the recalculated interval is supplementary.

Only 25 participants in the aripiprazole group and 26 in control contributed to the primary outcome analysis. The registry also records overall enrollment of 125 and a planned figure of 258 in the brief summary. These numbers describe different aspects of the record and should not be treated as interchangeable. The registry record does not report the number originally planned in the sponsor's formal sample-size calculation, the reasons for the observed enrollment, or a detailed account of missing primary outcome measurements.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total events. They are illustrations calculated from the observed effect, not the trial's original design assumptions. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect used for each illustration is a stated fraction of the observed effect. The registry record does not report the original sample-size justification or the assumptions used when the trial was designed.

The 80% power column describes the number of participants per arm that the illustration estimates would be needed to have an 80% chance of detecting the specified effect under those assumptions. The 90% power column gives the corresponding number for a 90% chance. These are conditional planning quantities: they depend on the assumed effect and the calculation assumptions. They are not descriptions of the trial's observed probability of finding a result.

For the primary comparison, planning for 100% of the observed effect gives 45 participants per arm for 80% power and 60 for 90% power. Planning for 75% of the observed effect gives 80 per arm for 80% power and 106 for 90% power. Planning for 50% of the observed effect gives 178 per arm for 80% power and 238 for 90% power. The pattern illustrates that smaller effects require more participants to detect, all else being equal. These figures are not observed power.

The planning illustration is not evidence that the study was designed around these values. The brief summary describes an intention to randomize 258 patients, while the enrollment field records 125; the reason for this difference is not reported in the registry record.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -12.360; pooled standard deviation σ = 20.797.
2. n = 2 × (1.96 + 0.842)² × 20.797² / -12.360² = 44.4, rounded up to 45 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -12.36                      # observed difference in means
sigma <- 20.7969410034755                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(508157)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 45 (80% power), 60 (90% power)
 75% of observed effect: n per arm = 80 (80% power), 106 (90% power)
 50% of observed effect: n per arm = 178 (80% power), 238 (90% power)
power.t.test: 45.4 
Simulated power at n = 45 per arm: 0.797 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry reports the sponsor's primary comparison as an ANCOVA estimate of mean difference (final values) of -11.28, with a 95% confidence interval from -19.14 to -2.66. The registry does not provide a p-value for this analysis. It does identify the method as ANCOVA but does not report the complete model specification, including the covariates used.

The simple recalculation from posted summary statistics is unadjusted. It estimates a mean difference of -12.36, with a 95% confidence interval from -23.75 to an upper limit below zero, and an unadjusted p-value of 0.033. It is a check based on the group summaries, not an attempt to reproduce the sponsor's adjusted model. Differences between the two estimates and intervals are therefore not, by themselves, evidence of an error.

The sponsor's analysis takes precedence as the trial's own reported analysis. The recalculation is useful as a separate, transparent comparison based on summary data, but it cannot supply missing details about the ANCOVA or replace the sponsor's model. The registry record does not identify additional sponsor analyses for the primary endpoint.

15. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary endpoint and eight secondary outcomes, but it does not report a multiplicity adjustment strategy. It is therefore not reported in the registry record whether the study planned to control the overall false-positive risk across multiple outcomes, comparisons, or time points. The recalculated p-value for the primary endpoint is explicitly unadjusted. The sponsor's primary ANCOVA p-value is not reported, and the record does not give p-values for the posted secondary analysis.

General explanation: when multiple hypotheses are tested, interpreting each test at the same nominal threshold can make it more likely that at least one result appears statistically notable by chance. A prespecified testing sequence or adjustment can address this issue. Without a reported strategy, secondary comparisons should not be treated as if each independently provided confirmatory evidence. This caution does not establish that any particular reported result is false; it concerns the strength of inference when the full testing context is unknown.

Missing-data handling is partly described. The primary analysis used an LOCF data set. Measurements after a participant began lipid-lowering treatment were excluded, with the last earlier measurement used for LOCF analyses. The record also indicates that baseline data were carried forward for participants without an on-treatment measure, but the description is truncated. The registry does not report the number of missing measurements, reasons for missingness, or sensitivity analyses under alternative assumptions.

The primary analysis population is described through those LOCF rules. The registry record does not report a full intention-to-treat definition, a per-protocol population, or how participants with deviations from assigned treatment were handled. Nor does it report interim analyses, stopping boundaries, or a detailed statistical analysis plan. The study status is listed as terminated, but the reason for termination and whether it affected the analysis plan are not reported in the registry record.

16. 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 5% reporting threshold.

Most frequent non-serious adverse event terms

The posted adverse-event figures report zero serious adverse events among 25 participants in the aripiprazole group and zero among 26 in control. Other adverse events were recorded for 9 participants in the aripiprazole group and 2 in control. These are participant counts, not estimates of comparative risk adjusted for follow-up or other factors.

The registry does not provide serious adverse-event terms, since no serious events are listed in the posted group figures. Death counts are recorded as null, so deaths are not reported in the registry record; a null entry should not be interpreted as a confirmed count of zero. The record does not provide the event definitions, severity details for other adverse events, causal assessments, or a fuller account of exposure and follow-up for these safety summaries.

These counts are descriptive and should be interpreted in the context of the limited number of participants represented in the outcome groups and the 16-week study period. They do not establish that an event was caused by a treatment, nor do they provide a complete safety profile. No medical recommendation follows from these figures alone.

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

The posted primary analysis indicates a negative mean difference in percent change in fasting non-HDL cholesterol for aripiprazole compared with continued atypical antipsychotic treatment. The sponsor-reported estimate is -11.28, and its 95% confidence interval runs from -19.14 to -2.66. The interval is entirely below zero, while the registry does not report a p-value for that analysis. The unadjusted recalculation also estimates a negative contrast, but it is not the sponsor's adjusted analysis.

This finding is specific to the primary metabolic endpoint, the participants included in the analysis, the 16-week follow-up, and the reported LOCF and lipid-lowering-treatment rules. It does not show that every participant experienced a decrease, and it does not establish the effect on every lipid, metabolic, clinical, or quality-of-life outcome. The registry record does not report a clinical threshold for interpreting the magnitude of the primary difference.

The study was randomized but open-label, and the registry does not give important details of the randomization procedures or the covariates used in the ANCOVA. The recorded enrollment was 125, while the brief summary described an intention to randomize 258. The record does not explain the difference or the reason for termination. These uncertainties matter when judging how broadly the result can be applied and how completely the analysis can be assessed.

The results do not establish longer-term outcomes, effects in populations beyond those enrolled, or a mechanism for any observed difference. They are not individualized predictions and do not constitute treatment advice. Statistical evidence about this endpoint should be considered alongside the trial's design, analysis limitations, and the full body of relevant evidence, which is not described in the registry record.

18. Why This Trial Matters Statistically

This trial is statistically notable because its primary endpoint is a continuous metabolic measure, while its treatment comparison is between switching to aripiprazole and continuing one of several existing atypical antipsychotics. The control group is therefore a group of ongoing treatments rather than one uniform named drug. That distinction affects what the estimated group contrast represents.

The registry reports both an ANCOVA result and enough summary information for a simple unadjusted recalculation. Comparing them illustrates why the adjustment and model definition matter: the sponsor's reported estimate is the trial's own analysis, whereas a calculation from group summaries answers a simpler, unadjusted question. The record does not provide enough model detail to reproduce the ANCOVA independently.

The endpoint analysis also illustrates how missing-data conventions can shape an estimate. LOCF and the rule excluding measurements after lipid-lowering treatment began are part of the stated analysis population, not incidental details. Without the number and pattern of missing observations or sensitivity analyses, readers cannot assess how strongly alternative missing-data assumptions might affect the result.

Finally, the registry's enrollment figure and its stated intended enrollment differ, and the study is listed as terminated. The record does not explain either circumstance. These features are important for transparent statistical interpretation: enrollment influences precision, while incomplete design and stopping information limits the assessment of why the observed sample differs from the stated intention. The reported confidence interval communicates uncertainty in the endpoint estimate, but cannot resolve those missing design details.

19. 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 describes the study as randomized and open-label but does not report the method used to generate or conceal assignment. It also does not provide the ANCOVA covariates or full model specification. These omissions limit independent assessment and reproduction of the sponsor-reported analysis.

The brief summary describes an intention to randomize 258 patients, whereas enrollment is recorded as 125. The study status is terminated, but the reason for termination and the relationship, if any, between termination and enrollment are not reported in the registry record. The record also does not state the original sample-size justification. The planning illustrations based on the observed effect are not a substitute for that missing design rationale.

The primary outcome population used LOCF, and measurements after lipid-lowering treatment started were excluded in favor of the last earlier measurement. Baseline values were also carried forward for participants without an on-treatment measure, although the registry text is truncated at this point. The number of missing measurements and the results of analyses using alternative missing-data assumptions are not reported.

The registry lists several secondary outcomes, but individual results are not reported for the full set. It does not state whether multiplicity was addressed, and it does not report interim analyses or a detailed statistical analysis plan. The treatment arms also differ in their control regimen composition because participants could continue risperidone, quetiapine, or olanzapine. These features limit interpretation of the comparison as a contrast against any one specific drug.

Safety reporting is brief: serious-event counts are zero in the two groups, other adverse-event counts are reported, and death counts are null. Event terms and fuller safety details are not reported in the registry record.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome — NCT00508157.
• Registry record last updated 2013-12-13; status last verified 2013-11.
• Results first posted 2010-07-20.
• 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.

23. Record Summary

This Phase 4 study was a randomized, parallel-group, open-label comparison of aripiprazole with continued atypical antipsychotic treatment in people with schizophrenia and metabolic syndrome. The planned treatment period was 16 weeks. The registry lists Bristol-Myers Squibb as sponsor, a start date of 2007-11, a primary completion date of 2009-03, and a status of terminated.

The primary endpoint was mean percent change in fasting non-HDL cholesterol at Week 16. The sponsor-reported ANCOVA estimated a mean difference of -11.28, with a 95% confidence interval from -19.14 to -2.66. Enrollment was recorded as 125; the brief summary described an intention to randomize 258. The reason for termination and the explanation for the enrollment difference are not reported in the registry record.