Serotonin Selective Reuptake Inhibitor Treatment of Dual Diagnosis Post-traumatic Stress Disorder and Alcohol Problems: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Serotonin Selective Reuptake Inhibitor Treatment of Dual Diagnosis Post-traumatic Stress Disorder and Alcohol Problems (NCT02504931), a randomized phase 4 study. The primary outcome is Percent Heavy Drinking Days.

2. Clinical Question

The trial asks whether adding sertraline to cognitive and behavioral therapy is associated with different outcomes than adding placebo for veterans with co-occurring PTSD and alcohol problems. The registry describes an interest in both PTSD symptom improvement and reduced alcohol consumption, and in whether subgroups defined by alcohol-dependence subtypes respond differently. The posted primary outcome concerns heavy drinking days; a PTSD symptom score is listed as a secondary outcome.

The clinical question is therefore about the contrast between two medication strategies within a therapy context, not about medication in isolation. Because both arms received a behavioral therapy component, the posted arm comparison does not separate the contribution of that shared care from the contribution of the assigned medication. The registry record does not report results for the proposed alcohol-dependence subgroups.

3. Trial Design

This was a phase 4 randomized, parallel-group trial listed as completed. The registry records enrollment of 49 participants and compares sertraline with placebo. The planned treatment period is described as 12 weeks, with both medication arms paired with cognitive and behavioral therapy. The primary outcome is reported at 12 weeks.

The registry identifies the trial as triple-masked. Which specific groups of people were masked is not reported in the registry record, so the masking label cannot be interpreted more specifically. Details of sequence generation, allocation concealment, and the process used to maintain masking are also not reported in the registry record.

The sertraline arm description gives a fixed dose of 150 mg per day after an initial increase in dose. The placebo arm used matching capsules, and its description identifies COPE therapy. The brief summary characterizes the study as sertraline versus placebo as an adjunct to manualized cognitive and behavioral therapy. More complete operational details of therapy attendance, treatment adherence, and medication adherence are not reported in the registry record.

The registry lists a start in 2011-04 and primary completion in 2016-08. It does not report the original design assumptions or the reasoning used to select the enrollment target. The posted outcome summaries include 26 participants in the sertraline arm and 23 in the placebo arm for the primary outcome. The registry record does not provide a participant flow account explaining whether these figures represent all randomized participants or how any missing outcome data were handled.

The trial's stated aims included identifying alcohol-dependence subgroups that might respond differently to SSRI treatment. No subgroup results are reported in the registry record, and no reported analyses are posted. Consequently, the available results support interpretation of the posted arm summaries and unadjusted contrasts, but do not allow assessment of the proposed subgroup objective or a more detailed account of the planned analysis.

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

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 Percent Heavy Drinking Days, measured over 12 weeks.

The primary endpoint is percent heavy drinking days over the 12-week period. Participants reported the number of heavy drinking days, and the percentage of days in the period was calculated. The registry reports the mean and standard deviation for each arm. In the sertraline arm, the mean was 55.5 percentage of days, with a standard deviation of 24.8, among 26 participants. In the placebo arm, the mean was 65.1 percentage of days, with a standard deviation of 24.1, among 23 participants.

This measure expresses heavy drinking frequency relative to the observation period, rather than as a raw count of days. A mean summarizes the arm's average percentage, while the standard deviation describes how spread out individual participants' values were around that average. The endpoint is relevant to the trial's stated interest in alcohol consumption, and it is the primary outcome identified in the registry.

The reported summaries do not explain how heavy drinking days were defined, how reports were collected, or how incomplete reporting was addressed. Those details are not reported in the registry record. The endpoint is measured during treatment; the registry does not report a later follow-up result for this outcome.

7. Results Posted in the Registry

• Sertraline: mean 55.50 versus 65.10 on control; difference -9.60 (95% CI -23.31 to 4.11), standardized effect d = -0.39; z-test p = 0.170.

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.

PTSD (Post Traumatic Stress Disorder) Symptom Score From PCL (Patient Monitoring Checklist)

• 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:
  • Sertraline: mean 59.60 versus 61.70 on control; difference -2.10 (95% CI -8.11 to 3.91), standardized effect d = -0.20; z-test p = 0.493.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Sertraline and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcome is a PTSD symptom score measured after 12 weeks of treatment. Its arm summaries and unadjusted comparison point in the same broad direction as the primary result: the sertraline-arm mean is lower than the placebo-arm mean. The secondary estimate is also uncertain, with a confidence interval that includes zero. This directional resemblance does not establish that both outcomes reflect a common treatment effect, since they measure different aspects of the dual diagnosis.

The secondary endpoint relates to the trial's stated interest in PTSD symptoms, while the primary endpoint concerns heavy drinking days. Considering both outcomes gives a broader descriptive view of the trial's aims, but the secondary finding should not be treated as independent confirmation of the primary comparison. The measures are collected in the same study and may reflect overlapping participants, treatment experience, or other shared influences. The registry record does not report analyses of relationships between the outcomes.

Unadjusted secondary results carry less weight for confirmatory interpretation when multiple outcomes or analyses may be considered. In general, testing multiple questions can increase the chance that at least one result appears notable by chance. A prespecified hierarchy or multiplicity adjustment can address that issue, but neither is reported in the registry record. The secondary result is therefore best read as descriptive evidence rather than a separately established conclusion.

The registry lists one secondary outcome and no reported analyses. It does not explain whether additional outcomes were planned but not posted, whether the secondary endpoint was prespecified in an analysis plan, or whether any adjustment across outcomes was used. These gaps limit the strength of inference that can be drawn from the secondary result and make it important to distinguish the posted arm summaries from a complete account of the trial's analysis.

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

• PTSD (Post Traumatic Stress Disorder) Symptom Score From PCL (Patient Monitoring Checklist)

9. Statistical Interpretation

10. Statistical Methods Explained

The registry reports continuous outcomes as means with standard deviations. For the primary endpoint, the mean is the average percent heavy drinking days within an arm. The standard deviation describes participant-to-participant spread around that arm mean; it is not the uncertainty in the mean difference itself. The same type of summary is reported for the secondary PTSD symptom score.

What does the mean difference represent?

The primary contrast is a difference between the sertraline and placebo arm means, calculated as sertraline minus placebo. Its estimate is -9.6 percentage points. A negative value means the observed mean was lower in the sertraline arm, because the sertraline mean was 55.5 and the placebo mean was 65.1. The contrast is unadjusted: it compares the posted arm summaries without adjustment for other participant characteristics or any reported model terms. No adjusted estimate is reported in the registry record.

A difference in means is expressed in the outcome's original units, which makes its direction and scale directly interpretable. It does not, by itself, describe how much individual participants overlap across arms, nor does it establish that the observed contrast is attributable to medication rather than chance or other features of the trial. Random assignment is intended to support a fair comparison, but the registry record does not report the allocation procedure or a detailed account of the analysis.

How should the confidence interval and p-value be read?

A confidence interval communicates the statistical uncertainty around an estimated contrast. For the primary outcome, the 95% confidence interval extends from -23.31 to 4.107. Because it includes zero, the interval includes no mean difference as well as differences in either direction. It is not a statement that there is a 95% probability that the true value lies inside this particular interval. Rather, in general, a confidence interval is produced by a procedure that would cover the target value at its stated rate over repeated use under the model assumptions.

The unadjusted p-value is 0.17. In general, a p-value measures how unusual data at least as discrepant as those observed would be under a specified null model. It is not the probability that the null hypothesis is true, and it does not measure the clinical importance of the estimate. The registry does not report a sponsor analysis or a detailed statistical analysis plan, so the unadjusted contrast should be understood as a recalculation from posted summary statistics, not as a fully described model-based analysis.

Why do the arm standard deviations matter?

Standard deviations describe the variability of participant measurements, which affects how precisely an arm mean and the between-arm contrast can be estimated. Greater variability generally makes a mean difference harder to estimate precisely when sample sizes are otherwise similar. This trial's primary outcome has standard deviations of 24.8 and 24.1 in the two arms. These are descriptive measures of spread, not confidence limits and not standard errors.

The comparison also reports a pooled standard deviation of 24.47 as part of the unadjusted recalculation. A pooled standard deviation combines information about spread across arms for a standardized comparison. The standardized effect can help describe the contrast relative to the observed variability, but it is not expressed in percentage points and should not replace the original-scale difference when interpreting the primary endpoint. No particular clinical threshold for the primary outcome is reported in the registry record.

What does over-dispersion mean in general?

In general, over-dispersion occurs when observed variation is greater than a model expects. If a statistical model assumes less variability than the data actually contain, its uncertainty estimates can be too narrow and its inferential results too optimistic. The registry does not report an over-dispersion assessment or a model for the primary outcome. The posted outcome is a percentage and is summarized by a mean and standard deviation, but the record does not provide enough information to determine whether a distributional model was used or whether its assumptions were checked.

The uncertainty in a comparison can also be affected by the way measurements are collected and by dependence among repeated measurements. The registry's primary endpoint summarizes days over a 12-week period, but a participant-level analysis model and the handling of repeated or incomplete reports are not reported in the registry record. It would therefore be speculative to claim that a particular distributional assumption, adjustment, or repeated-measures method was used.

What can be inferred from the reported analysis status?

The registry lists no reported analyses. It nevertheless posts arm-level outcome summaries and unadjusted recalculated contrasts, including confidence intervals and p-values. These have different roles: the arm summaries describe the posted data; the recalculated contrasts provide a simple comparison from those summaries; and neither supplies the missing details of a sponsor's planned or conducted statistical analysis. The registry record does not report covariate adjustment, an intention-to-treat definition, a per-protocol analysis, missing-data methods, or a multiplicity strategy.

Randomization, parallel allocation, and triple masking are recorded design features. In general, randomization helps balance measured and unmeasured characteristics across treatment assignments in expectation, while masking can reduce some forms of biased behavior or assessment. These design labels do not reveal how assignment was generated, who was masked, whether masking was maintained, or how deviations from assigned treatment were addressed. Those implementation details are not reported in the registry record.

11. Confidence Intervals and Precision

The primary mean difference is -9.6 percentage points, with a 95% confidence interval from -23.31 to 4.107. The interval is wide enough to include a lower mean in the sertraline arm, little or no difference, and a value in the opposite direction. It therefore does not pin down the size of the between-arm contrast with high precision. The unadjusted p-value of 0.17 is consistent with substantial uncertainty, but the interval is more informative than the p-value alone because it shows the range of contrasts compatible with the recalculation.

Precision depends in part on sample size and variation in the outcome. The primary summaries include 26 participants in the sertraline arm and 23 in the placebo arm, with standard deviations of 24.8 and 24.1. The registry record does not report the original sample-size justification or the anticipated variability used in planning. It is therefore not possible to compare the observed precision with the trial's original expectations.

A confidence interval is not a range containing every plausible value, and it does not account for every possible source of uncertainty. In particular, it cannot resolve questions about missing outcomes, analysis populations, outcome measurement, or unreported analysis decisions. Those details are not reported in the registry record. The interval characterizes uncertainty under the unadjusted recalculation's assumptions, rather than correcting for those documentation gaps.

The posted secondary comparison also has a confidence interval that includes zero. As with the primary result, this indicates that the estimated contrast is not precise enough to distinguish a difference from no difference under the unadjusted calculation. The secondary result should not be used to sharpen the primary estimate: it measures a different outcome and is not reported as part of a jointly adjusted analysis.

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 based on the observed effect and use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each row considers detecting the stated fraction of the observed effect: 100%, 75%, or 50%. The trial's own original design assumptions and sample-size justification are not reported in the registry record.

The 80% power column describes the number of participants per arm that the planning calculation estimates would be needed for an 80% chance of detecting the specified effect under the stated assumptions, if that effect were the true one and the assumptions held. The 90% power column uses a higher target chance of detection and therefore gives a larger required number for the same effect scenario. These are planning illustrations, not evidence about what the completed trial was capable of detecting in practice.

Smaller effects require more participants because they are harder to distinguish from ordinary sampling variation. Accordingly, planning for 75% or 50% of the observed effect yields larger participant requirements than planning for the full observed effect. The calculations are tied to an effect estimated in a relatively small trial and should be read as conditional illustrations, not as a validated estimate of a future treatment difference. This is not observed power.

The registry does not report that its original enrollment target was chosen from these calculations; the calculations are based on the observed effect rather than the trial's own design. They do not account for any unreported features such as attrition, analysis adjustments, or a different outcome model. The figures should therefore be used to understand how assumed effect size and desired power affect planning, not as a retrospective score of the trial.

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 = -9.600; pooled standard deviation σ = 24.475.
2. n = 2 × (1.96 + 0.842)² × 24.475² / -9.600² = 102.0, rounded up to 103 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 <- -9.59999999999999                      # observed difference in means
sigma <- 24.4748329270806                     # 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(2504931)
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 = 103 (80% power), 137 (90% power)
 75% of observed effect: n per arm = 182 (80% power), 243 (90% power)
 50% of observed effect: n per arm = 409 (80% power), 547 (90% power)
power.t.test: 103 
Simulated power at n = 103 per arm: 0.798 (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. Multiplicity, Missing Data and Analysis Populations

The registry identifies percent heavy drinking days as the primary outcome and posts a PTSD symptom score as a secondary outcome. It does not report a statistical analysis plan describing how the outcomes were prioritized, whether additional comparisons were planned, or whether any multiplicity adjustment was applied. No multiplicity correction is reported in the registry record. When several outcomes or analyses are examined, the chance of a false-positive result can increase; in general, adjustment or a prespecified testing hierarchy can help control that risk.

The registry record lists no reported analyses, although it posts arm summaries and unadjusted recalculated contrasts. It does not report whether the sponsor conducted adjusted analyses, subgroup analyses, sensitivity analyses, or an analysis using a specified population such as all randomized participants. The record also does not state how participants who stopped treatment, deviated from assigned treatment, or lacked outcome measurements were handled.

Missing-data handling is particularly relevant to the interpretation of arm means. The posted primary outcome summaries include 26 participants in the sertraline arm and 23 in the placebo arm, but the registry does not provide a flow account or explain whether these counts represent everyone randomized, everyone treated, or those with observed endpoint data. The amount and pattern of missing data are not reported in the registry record. Without those details, it is not possible to assess whether the reported means could be affected by selective availability of outcome measurements.

The registry does not report an analysis population definition, imputation method, or assumptions about missing outcomes. In general, different methods can yield different estimates when some outcomes are unavailable, especially if missingness relates to treatment experience or outcome severity. No particular missing-data mechanism should be assumed for this trial. The same caution applies to subgroup analyses: the rationale mentions alcohol-dependence subtypes, but subgroup definitions, interaction tests, and subgroup results are not reported in the registry record.

These omissions do not change the posted numerical summaries, but they constrain how strongly those summaries can be interpreted. The unadjusted contrasts should not be mistaken for a documented full analysis plan or a complete account of all analyses performed.

15. 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 non-serious adverse event terms

The registry posts zero serious adverse events in the sertraline arm and zero in the placebo arm. It also records zero deaths in each arm. These counts describe the events posted in the registry; they do not by themselves establish that no serious events occurred outside the reporting period or that the arms have identical safety profiles.

The record separately reports other adverse events affecting 23 of 26 participants in the sertraline arm and 18 of 23 in the placebo arm. These are participant counts with an event, not event counts by type or severity. The registry does not provide the specific terms for these other adverse events in the information. No serious adverse-event terms are posted.

Interpretation is limited by the lack of further detail about event definitions, collection methods, timing, relatedness to treatment, or withdrawals due to adverse events. The available counts should therefore be read as a registry summary rather than a complete safety analysis. They do not establish whether a particular event was caused by the assigned medication, and they do not support conclusions beyond the recorded counts.

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

The posted primary outcome means are lower in the sertraline arm than in the placebo arm, and the unadjusted recalculated contrast is negative. The confidence interval includes zero, however, and spans values in both directions. The data therefore do not provide a precise estimate of the between-arm difference. The secondary PTSD symptom comparison is also uncertain. Neither result should be described as proof that sertraline improves or fails to improve either condition.

The results concern the comparison of sertraline plus therapy with placebo plus therapy, not sertraline without therapy. They apply to the outcomes and time frame posted in the registry: heavy drinking days and a PTSD symptom score at 12 weeks. The registry does not report longer-term outcomes, so these data do not describe whether any differences persisted after the treatment period.

The enrollment was 49, and the posted outcome summaries include 26 participants in the sertraline arm and 23 in the placebo arm. Further participant characteristics are not reported in the registry record. The findings therefore cannot be extended confidently to populations beyond the veterans described in the study summary. The record does not report the demographic or clinical detail needed to assess how closely other populations resemble these participants.

The trial description proposes examining alcohol-dependence subgroups, but subgroup results are not reported in the registry record. The posted results cannot establish which, if any, subtype might have a different response. Nor do the results show that a particular subgroup should receive a particular treatment. The outcome summaries are group-level comparisons and do not provide a basis for individual treatment decisions.

Statistically, the central message is limited precision: the point estimates favor lower means in the sertraline arm, but the uncertainty intervals include no difference and an opposite-direction contrast. Missing-data methods, analysis populations, and multiplicity handling are not reported, adding uncertainty about the analytical context. The registry record describes what the posted summaries show, but not enough detail to resolve those limitations.

17. Why This Trial Matters Statistically

This trial is statistically informative because it illustrates the distinction between the direction of an estimate and the precision of the evidence. Both posted mean contrasts point toward lower scores in the sertraline arm, but both are uncertain. A directional point estimate alone does not establish a clear between-arm difference; the confidence interval is essential for seeing the range of values compatible with the unadjusted comparison.

The record also demonstrates why arm summaries are not a substitute for a full analysis account. Means, standard deviations, and participant counts allow a simple unadjusted comparison, but they do not explain participant flow, missing outcomes, analysis populations, or adjustment for multiple outcomes. Those details affect how confidently readers can interpret even correctly calculated estimates.

The dual-diagnosis setting adds a further statistical question: the study's stated interest includes whether subgroups defined by alcohol dependence respond differently. That question requires subgroup definitions and an analysis that tests whether responses differ between subgroups, not merely a comparison of arm averages. The registry does not report such results. The broad objective therefore cannot be evaluated from the posted outcome summaries.

Finally, the planning illustrations show how assumptions about effect size and desired power influence the number of participants required. They are based on the observed effect and are distinct from the trial's original design justification, which is not reported in the registry record. Keeping those roles separate prevents retrospective planning calculations from being mistaken for evidence about the study's actual design choices or statistical power.

18. 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 provides limited detail about the participants beyond their description as military veterans with PTSD and alcohol dependence. Demographic characteristics, baseline outcome values, and the distribution of clinical features are not reported in the registry record. This limits assessment of the study population and of how broadly its results might apply.

The trial combines medication assignment with cognitive and behavioral therapy. Since both arms include a therapy component, the arm contrast concerns the added medication strategy within that treatment context. The registry record does not report therapy attendance, treatment fidelity, medication adherence, or the extent to which participants received the intended regimens. It is not possible to separate these implementation details from the posted results.

The primary outcome relies on participant reports of heavy drinking days over 12 weeks. The registry describes the calculation but does not report the operational definition of a heavy drinking day, the reporting instrument, or procedures for incomplete reports. The posted outcome is limited to the treatment period; longer-term follow-up results are not reported in the registry record.

The analysis record is also sparse. No reported analyses are listed, and details of the analysis population, missing-data handling, covariate adjustment, and multiplicity strategy are not reported. The arm summaries support simple unadjusted comparisons, but cannot answer questions that depend on those unreported methods. The registry's proposed subgroup objective has no posted results, so differential response by alcohol-dependence subtype cannot be assessed.

The number enrolled was 49, and the outcome summaries use 26 participants in one arm and 23 in the other. The registry does not explain participant flow or whether the outcome counts correspond to all randomized participants. Together, the modest enrollment and absent analysis details limit the precision and interpretability of the posted comparisons, without changing the direction of the observed means.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Serotonin Selective Reuptake Inhibitor Treatment of Dual Diagnosis Post-traumatic Stress Disorder and Alcohol Problems — NCT02504931.
• Registry record last updated 2018-04-10; status last verified 2017-04.
• Results first posted 2018-02-27.
• 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.

22. Record Summary

The registry describes a completed, phase 4 randomized, parallel-group, triple-masked trial of sertraline versus placebo as an adjunct to cognitive and behavioral therapy in veterans with PTSD and alcohol dependence. Enrollment was 49. The primary endpoint was percent heavy drinking days at 12 weeks; the registry also posts a PTSD symptom score.

The primary arm means were 55.5 in the sertraline arm and 65.1 in the placebo arm. The unadjusted recalculated mean difference was -9.6, with a 95% confidence interval from -23.31 to 4.107 and an unadjusted p-value of 0.17. The interval includes zero, so the size and direction of the underlying difference remain uncertain. The secondary comparison is also uncertain.

The registry does not report the trial's original sample-size justification, detailed analysis methods, missing-data handling, multiplicity strategy, or subgroup results. The posted summaries support a limited interpretation of the reported outcomes, not a complete account of the trial's planned or conducted analyses.