A Study of JZP150 in Adults With Posttraumatic Stress Disorder: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of JZP150 in Adults With Posttraumatic Stress Disorder (NCT05178316), a randomized phase 2 study. The primary outcome is Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score.

2. Clinical Question

The CAPS-5 is a clinician-administered interview about PTSD symptoms. Its total score ranges from 0 to 80, with higher scores indicating more severe symptoms. The recorded endpoint is the mean change over the stated timeframe. Negative mean changes indicate improvement in the measured symptom score, but the central comparison is the difference in change between each JZP150 group and placebo.

This distinction matters because a change within a treatment group does not by itself establish a difference between groups. The placebo group also had a negative mean change. The statistical question is therefore whether the observed group contrast is sufficiently separated from zero, considering its uncertainty and the analysis used. The registry reports mixed-model comparisons as well as group means and standard deviations; the posted results do not establish a conclusion beyond the comparisons and their precision.

3. Trial Design

The registry describes NCT05178316 as a completed, multicenter, phase 2, 12-week, randomized, double-blind, placebo-controlled, parallel-group study. Its title identifies adults with posttraumatic stress disorder as the study population. The registry lists enrollment as 282. Enrollment is a record-level study figure and should not be treated as the number contributing data to every outcome: the primary outcome reports available-data analysis groups of 44.0 for JZP150 0.3 mg, 79.0 for JZP150 4.0 mg, and 85.0 for placebo.

Participants were assigned to one of three listed regimens: JZP150 0.3 mg orally once daily, JZP150 4.0 mg orally once daily, or placebo orally once daily, each for up to 12 weeks. Randomization and double masking are stated in the record. Which specific people were masked, how allocation was implemented, and whether masking was assessed are not reported in the registry record. The listed parallel-group design means the arms are presented as separate groups rather than as a crossover comparison; further protocol details are not reported in the registry record.

The study start date is 2021-12-29, and the primary completion date is 2023-12-05. The record lists the study status as completed. Those dates describe the registry record and do not, on their own, provide information about recruitment progress, follow-up completeness, or the timing of analysis. The registry includes one primary outcome and two secondary outcomes. The original sample-size justification, planned enrollment by arm, and original statistical analysis plan 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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: CAPS-5 total symptom severity score was assessed in participants with available data in the Full Analysis Set 1.

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.

Population: Baseline characteristics were assessed in the Safety Analysis Set.

6. Primary Endpoint

The registry lists the primary outcome as Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score, measured over Baseline to Week 12.

The primary endpoint is mean change from baseline to Week 12 in the Clinician Administered Posttraumatic Stress Disorder Scale total symptom severity score, CAPS-5. The scale is based on a clinician-administered interview in which participants report PTSD symptoms. The total score ranges from 0 to 80; higher scores indicate more severe symptoms. The registry defines negative mean changes as improvement in clinical outcome.

Change from baseline is used to describe how the measured score shifts over the specified study period. Comparing changes between randomized groups helps separate the observed course in a JZP150 arm from the observed course in the placebo arm. The comparison is a difference in mean changes, not a comparison of whether either group changed from its own baseline. A negative within-group change does not alone show that the treatment group changed more than placebo.

The outcome description identifies the population as participants with available data in Full Analysis Set 1. The registry does not provide further detail in this record about how that set was defined or how missing endpoint observations were handled. CAPS-5 is a symptom-severity measure; the posted primary result therefore addresses this score over the stated interval, not every aspect of PTSD, functioning, safety, or longer-term outcomes.

7. Results Posted in the Registry

• JZP150 0.3 mg: mean -17.00 versus -17.60 on control; difference 0.60 (95% CI -4.20 to 5.40), standardized effect d = 0.05; z-test p = 0.806.
• JZP150 4.0 mg: mean -17.80 versus -17.60 on control; difference -0.20 (95% CI -3.97 to 3.57), standardized effect d = -0.02; z-test p = 0.917.

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.

Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • JZP150 0.3 mg: mean -1.40 versus -1.20 on control; difference -0.20 (95% CI -0.60 to 0.20), standardized effect d = -0.18; z-test p = 0.325.
  • JZP150 4.0 mg: mean -1.30 versus -1.20 on control; difference -0.10 (95% CI -0.46 to 0.26), standardized effect d = -0.08; z-test p = 0.584.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between JZP150 0.3 mg and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between JZP150 4.0 mg and the control. The interval gives the range of effects that remain compatible with the data.

Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • JZP150 0.3 mg: mean -1.00 versus -1.00 on control; difference 0.00 (95% CI -0.42 to 0.42), standardized effect d = 0.00; z-test p = 1.000.
  • JZP150 4.0 mg: mean -1.10 versus -1.00 on control; difference -0.10 (95% CI -0.43 to 0.23), standardized effect d = -0.09; z-test p = 0.558.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between JZP150 0.3 mg and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between JZP150 4.0 mg and the control. The interval gives the range of effects that remain compatible with the data.

The two secondary outcomes are mean change from baseline to Week 12 in clinician-rated CGI-S and patient-rated PGI-S. Across both measures and both JZP150 doses, the recalculated contrasts with placebo are small, and the sponsor’s reported mixed-model confidence intervals include zero. This broad pattern is compatible with the primary result: the posted analyses do not show a clear separation from placebo across these severity measures.

These outcomes offer related but distinct assessments of severity, one clinician-rated and one patient-rated. Agreement in broad pattern can be informative, but the secondary outcomes do not independently confirm a treatment effect when their comparisons are uncertain. Nor should several similar findings be counted as separate proof: the outcomes concern related constructs and may not provide independent evidence.

The registry record does not report whether the secondary outcomes were part of a prespecified testing hierarchy or whether multiplicity was controlled. When several outcomes and treatment contrasts are examined, unadjusted results carry less weight because the chance of at least one apparently positive finding can rise across tests. This general concern applies even when the observed comparisons are not statistically notable. The secondary findings should therefore be interpreted as supportive context, not as stand-alone confirmatory evidence.

Further details about the instruments’ scoring interpretation, clinically important thresholds, and missing-data handling are not reported in the registry record. Without those details, the numerical changes and model estimates can be described, but their clinical importance and sensitivity to analysis choices cannot be fully assessed.

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

• Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)
• Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is continuous: it is a mean change in a score. For each arm, the registry posts the mean change, standard deviation, and number with outcome data. A standard deviation describes the spread of individual scores around the group mean; it is not the uncertainty of the mean itself. The posted group means describe average change, while the standard deviations indicate that participants’ changes varied within each arm.

What is the group contrast?

The recalculated contrast is the treatment-arm mean change minus the placebo-arm mean change. A contrast of zero would mean equal posted average changes. A positive or negative estimate indicates the direction of the difference using that subtraction order, not whether a participant improved or worsened. For the primary outcome, the recalculated estimates are 0.6 for JZP150 0.3 mg versus placebo and -0.2 for JZP150 4.0 mg versus placebo. These are simple, unadjusted comparisons from the posted summary statistics.

Standard errors quantify the sampling uncertainty of an estimate under the calculation’s assumptions. The recalculated comparisons use the posted group sizes and standard deviations to estimate uncertainty for the difference in means. The confidence intervals are built around these estimates and express a range of values compatible with the data under the method’s assumptions. They are not ranges containing a fixed proportion of individual participant outcomes, and they do not assign a probability to a particular treatment effect after observing the data.

Why distinguish the recalculation from the sponsor analysis?

The registry’s sponsor analyses use mixed models and report least-squares mean differences. A mixed model can estimate group contrasts while accounting for the structure of the data and, depending on its specification, repeated measurements or other modeled terms. The record names the method but does not report enough detail to reconstruct its specification, covariates, or handling of missing observations. A least-squares mean difference is therefore not identical by definition to a simple subtraction of posted arm means. Differences between the estimates can reflect the analysis model and the data it uses, not necessarily an error.

The recalculated p-values are unadjusted. A p-value is a measure of how incompatible the observed data are with a specified null model, assuming that model and the analysis assumptions hold. It is not the probability that the null hypothesis is true, nor a measure of clinical importance. The registry also reports sponsor p-values for its mixed-model analyses, but the registry record does not explain the full inferential plan or multiplicity adjustment. The sponsor’s stated method and estimates should therefore be kept distinct from the simple recalculations.

What assumptions matter?

For a continuous-outcome comparison based on means, the calculation treats the group summaries as informative about the underlying group distributions and uses an estimate of variability to quantify uncertainty. General statistical considerations include whether observations are independent, whether the chosen model is appropriate, and whether unusual distributions or influential observations affect the mean and standard error. The record does not provide participant-level data or diagnostic information to assess these issues. The registry does not report the original statistical analysis plan in this record, so additional assumptions used in the sponsor’s analysis are not reported in the registry record.

Randomization supports a comparison of assigned groups, but it does not remove uncertainty or guarantee that all analyzed groups are comparable in every respect. Outcome availability can also matter: the primary population is described as participants with available data in Full Analysis Set 1. The exact definition of that set and the missing-data method are not reported in the registry record. The reported group sizes are outcome-specific and should not be assumed to equal enrollment or to apply to every endpoint.

General statistical principle: when outcomes are tested across several treatment contrasts or endpoints, the chance of at least one apparently notable result can increase if each test is considered separately. Adjustment methods or a prespecified testing hierarchy can address that issue, but the record does not report whether such procedures were planned or applied. This is particularly relevant to secondary outcomes and should temper interpretation of unadjusted comparisons.

11. Confidence Intervals and Precision

For the primary endpoint, the 95% confidence interval for JZP150 0.3 mg versus placebo runs from -4.196 to 5.396 around the recalculated mean difference of 0.6. For JZP150 4.0 mg versus placebo, the interval runs from -3.969 to 3.569 around the estimate of -0.2. Both intervals include zero and span effects in either direction. Thus, the estimates are not precise enough to distinguish a small contrast from no contrast using these unadjusted calculations.

In general, a confidence interval reflects both the estimated effect and its uncertainty under the analysis assumptions. A narrower interval indicates greater precision; a wider interval leaves a broader set of values compatible with the data. An interval that crosses zero does not establish that the true effect is zero. It indicates that the data, as analyzed, do not exclude zero at the stated confidence level. Conversely, an interval excluding zero would not by itself establish clinical importance.

The sponsor’s mixed-model intervals also include zero: -3.98 to 4.60 for the 0.3 mg comparison and -4.32 to 2.84 for the 4.0 mg comparison. Because those are model-based least-squares mean differences and the recalculated intervals use unadjusted summary-statistic comparisons, they answer closely related but not identical analytical questions. The registry does not report a threshold for a clinically important CAPS-5 difference, so the intervals cannot be judged against such a threshold from this record.

Precision is also limited by the available outcome data and the observed variability. The primary outcome group sizes are 44.0, 79.0, and 85.0, and the posted standard deviations range from 11.99 to 13.75. These figures describe the data available for that endpoint, not the study’s original planned allocation. The original assumptions used to plan the trial are not reported in the registry record.

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 illustrations use the observed contrast as a starting point and show hypothetical participants per arm for two-sided testing at significance level 0.05, equal allocation between the two arms, and a normal approximation. For each illustration, the effect to detect is the stated fraction of the observed effect. These are planning calculations, not a reconstruction of the trial’s original design assumptions, which are not reported in the registry record.

The 80% power column gives the number of participants per arm that the stated calculation would require for an 80% chance of detecting the assumed effect under its assumptions if that effect were real. The 90% power column gives the corresponding planning target for a 90% chance. These are design probabilities for hypothetical future studies, not probabilities that the observed result is correct. The displayed quantities are participants per arm, not total participants or total events.

For example, using 100% of the observed primary contrast, the illustration lists 6,938 participants per arm for 80% power and 9,288 for 90% power for the 0.3 mg comparison. For the 4.0 mg comparison, it lists 59,205 participants per arm for 80% power and 79,259 for 90% power. The very large values arise because the observed contrasts are close to zero relative to the reported variability. The calculations are highly sensitive to the chosen effect: planning for a smaller effect requires more participants. The illustrations are not observed power and do not describe how many participants the completed study actually needed or enrolled by arm.

In general, power calculations depend on assumptions about the effect, variability, allocation, significance level, and statistical method. The posted calculations use the assumptions stated above; they should not be read as the sponsor’s original sample-size justification. The registry record does not report that original justification.

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 = 0.600; pooled standard deviation σ = 12.613.
2. n = 2 × (1.96 + 0.842)² × 12.613² / 0.600² = 6,937.5, rounded up to 6,938 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 <- 0.600000000000001                      # observed difference in means
sigma <- 12.6134336274472                     # 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(5178316)
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 = 6,938 (80% power), 9,288 (90% power)
 75% of observed effect: n per arm = 12,334 (80% power), 16,511 (90% power)
 50% of observed effect: n per arm = 27,750 (80% power), 37,150 (90% power)
power.t.test: 6938.4 
Simulated power at n = 6,938 per arm: 0.805 (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 analyses as mixed-model analyses of least-squares mean differences. For JZP150 0.3 mg versus placebo, the sponsor estimate is 0.31 with a 95% confidence interval from -3.98 to 4.60. For JZP150 4.0 mg versus placebo, it is -0.74 with a 95% confidence interval from -4.32 to 2.84. Both reported intervals include zero.

The recalculated estimates are simple, unadjusted comparisons based on the posted group means and standard deviations: 0.6 for the 0.3 mg comparison and -0.2 for the 4.0 mg comparison. Their intervals also include zero. The estimates differ because the sponsor’s mixed-model method is not the same calculation as a direct comparison of the posted summaries. The registry does not give enough model detail in this record to reproduce the sponsor analysis or explain the exact sources of those differences.

The recalculations are useful as a transparent check on the scale and direction of the posted group summaries, but they are not a substitute for the sponsor’s analysis. Since the registry reports the sponsor’s own model-based results and no discrepancy flag is recorded, the sponsor’s analysis takes precedence when describing the trial’s reported primary analysis. Neither analysis, as posted, establishes a clear treatment-placebo separation on the primary endpoint.

15. Multiplicity, Missing Data and Analysis Populations

The record lists one primary outcome and two secondary outcomes, with multiple treatment-versus-placebo comparisons. The registry’s reported analyses identify superiority comparisons, but the record does not report whether the testing sequence was hierarchical, whether any multiplicity adjustment was used, or how the overall type I error was controlled. A p-value considered without accounting for multiple tests can overstate the strength of evidence when many outcomes or contrasts are examined. This is a general statistical issue; it does not establish that an adjustment was absent from the full study documents.

The primary outcome population is described as participants with available data in Full Analysis Set 1. The registry record does not define that set further. It does not report whether the primary analysis followed intention-to-treat principles, how participants with missing Week 12 measurements were treated, or whether sensitivity analyses assessed the effect of missing data. Outcome-specific group sizes differ across the posted primary and secondary measures, so the number contributing data should be read for each outcome rather than inferred from enrollment.

Missing data can affect estimates if the probability of an observed score is related to outcomes or treatment assignment. General methods include model-based approaches and sensitivity analyses under alternative assumptions, but the appropriate interpretation depends on the actual analysis and missingness pattern. Those details are not reported in the registry record. The same limitation applies to the sponsor model’s covariates and repeated-measures specification: the method is named, but its full implementation is not described in this record.

The original sample-size assumptions, interim-analysis plan, and complete statistical analysis plan are not reported in the registry record. Their absence limits assessment of whether the reported analyses match prespecified decisions. It does not itself show that the analyses were inappropriate; it means that this record alone cannot resolve those questions.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: seizure (1.9%), pneumonia staphylococcal (0.9%), sepsis (0.9%), dehydration (0.9%), blood potassium decreased (0.9%).

The registry reports serious adverse events in 1 participant in the JZP150 0.3 mg group, 2 in the JZP150 4.0 mg group, and 1 in the placebo group. The corresponding serious-event risk groups are listed as 54, 113, and 110. Other adverse events are listed for 20, 30, and 24 participants, respectively, with risk groups of 54, 113, and 110. No deaths are reported in any group.

These are descriptive registry counts. They do not establish that an event was caused by study treatment, and they are not adjusted comparisons of risk. The record lists seizure at 1.9% among the top serious-event terms, and pneumonia staphylococcal, sepsis, dehydration, and blood potassium decreased at 0.9% each. The registry record does not provide further context about event timing, severity beyond the serious-event classification, or causal attribution.

Safety findings should be interpreted alongside the trial’s duration, population, and available follow-up. The record describes a 12-week study in adults with PTSD; these counts alone do not characterize risks outside that study setting or over longer periods. The registry’s outcome counts should not be taken as medical advice or as a complete assessment of a treatment’s safety profile.

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

The posted primary results describe mean CAPS-5 symptom-score changes over baseline to Week 12 and the estimated differences between each JZP150 dose and placebo. The group means were negative, which the registry defines as improvement in the measured score. However, the between-group estimates were close to zero, and their confidence intervals include zero. The sponsor’s mixed-model estimates likewise have intervals that include zero. The data therefore do not establish a clear difference from placebo in the reported primary comparisons.

That conclusion is narrower than saying the treatments have no effect. Failure to establish a difference does not prove that the true difference is exactly zero, and the intervals still include values on either side of zero. The registry record does not report an equivalence or noninferiority margin, so it does not support a formal conclusion that the groups are equivalent. It also does not identify a clinically important difference threshold for CAPS-5, limiting assessment of whether particular values within the intervals would matter clinically.

The result applies to the reported measure, population, treatment regimens, comparator, and study period. It does not by itself answer questions about other symptoms, functioning, longer-term outcomes, other populations, or other doses. The secondary measures show a broadly similar pattern of uncertain contrasts, but the record does not report multiplicity handling or enough analysis detail to treat them as confirmatory evidence.

Finally, the posted analyses do not settle questions about missing data or the full statistical model. Available-data group sizes are reported, but the definition of Full Analysis Set 1 and missing-data procedures are not reported in the registry record. The most defensible reading is therefore descriptive and bounded: the posted comparisons are near zero with uncertainty that includes no difference, under the analyses reported.

18. Why This Trial Matters Statistically

This trial illustrates why within-group improvement and a treatment-placebo contrast answer different questions. Each group’s CAPS-5 mean change was negative, but the treatment effect of interest is the difference between those changes. The placebo group’s own change provides an essential reference for interpreting the JZP150 groups. Looking only at change within a treatment arm could mistakenly attribute the full change to the treatment.

It also shows why estimates need to be read with their confidence intervals. The primary comparisons are close to zero, but the intervals span values in both directions. The point estimate alone would understate uncertainty; a p-value alone would not communicate the range of compatible effects. Together, the estimates and intervals convey that the posted results do not resolve a small difference from no difference.

The record also distinguishes model-based sponsor results from transparent unadjusted recalculations. Both approaches yield estimates near zero, but they are not interchangeable. Understanding the estimand, analysis population, model specification, and handling of missing data is important when interpreting randomized-trial results. Some of those details are not reported in this registry record, making clear boundaries around interpretation especially important.

Finally, planning illustrations based on an observed effect are not evidence about the trial’s original design or observed power. They demonstrate how strongly hypothetical sample-size needs can depend on the effect chosen, particularly when the observed contrast is small. This is useful statistical context, but it cannot replace the original design rationale, which is not reported in the registry record.

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 offers limited detail on the analysis population. It identifies participants with available data in Full Analysis Set 1 for the primary outcome, but does not define that set further or describe how missing measurements were handled. The posted group sizes are outcome-specific, and the record does not explain the reasons for differences in available data across outcomes.

The sponsor’s method is identified as mixed models analysis, but model specification, covariates, repeated-measures structure, and sensitivity analyses are not reported in the registry record. The recalculated comparisons use unadjusted summary statistics and cannot reproduce those model-based estimates. The original statistical analysis plan, multiplicity approach, and interim-analysis plan are also not reported in the registry record.

The record does not provide a clinically important difference threshold for CAPS-5 or an equivalence margin. Consequently, intervals that include zero cannot be used to determine whether clinically meaningful benefit or harm has been excluded. The outcome is measured through Week 12; longer-term effects are not addressed by this endpoint timeframe.

The primary outcome description states that higher CAPS-5 scores indicate more severe symptoms and that negative changes indicate improvement, but the registry record does not provide further details about instrument interpretation or individual-level response. The listed adverse-event counts are descriptive and do not establish causation. These limits do not negate the reported results, but they restrict how far the comparisons can be generalized or interpreted beyond the registry’s stated outcomes and analysis.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Study of JZP150 in Adults With Posttraumatic Stress Disorder — NCT05178316.
• Registry record last updated 2024-12-31; status last verified 2024-12.
• Results first posted 2024-12-31.
• 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

NCT05178316 is a completed, multicenter, phase 2, randomized, double-blind, placebo-controlled, parallel-group study of JZP150 in adults with posttraumatic stress disorder. It evaluated oral once-daily JZP150 at 0.3 mg or 4.0 mg against placebo for up to 12 weeks. Registry enrollment is 282.

The primary outcome was mean change in CAPS-5 total symptom severity from baseline to Week 12. The unadjusted recalculated comparisons with placebo were close to zero, and their 95% confidence intervals included zero. The sponsor’s reported mixed-model estimates also had intervals including zero. Two secondary severity outcomes showed a broadly similar pattern of uncertain comparisons.

The record reports adverse-event counts, including serious events, and no deaths in any group. The original sample-size justification, full analysis plan, multiplicity handling, and missing-data procedures are not reported in the registry record. Interpretation is therefore limited to the posted outcomes and analyses.