Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care (NCT00794196), a randomized na study. The primary outcome is Adherence to Antidepressant Medication.

2. Clinical Question

3. Trial Design

The study was a randomized, double-masked, parallel-group trial, with an enrollment of 179. The registry record identifies the intervention as a behavioral pharmaceutical care program and describes the two groups as receiving usual care alone or usual care plus the pharmaceutical support program. It does not report the randomization procedure, allocation ratio, or which people involved in the study were masked.

The registry record lists depression as the condition and describes the intended population as patients starting antidepressant treatment for depression. It lists the study phase as NA, which is the recorded value; further phase information is not reported in the registry record. The sponsor was Fundació Sant Joan de Déu. The recorded start was 2008-10, primary completion was 2011-11, and the status is completed.

The primary outcome was adherence to antidepressant medication, assessed at 3 and 6 months through pharmacy records. Patient wellbeing was listed as a secondary outcome. Although the record identifies two outcome measures, it lists 0 analyses. The adherence endpoint has multiple time points and is not reduced in the registry record to one comparison. Thus the trial design and intended outcomes can be described, but the reported record does not establish how the outcome data were analyzed or what the comparison found.

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:

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 Adherence to Antidepressant Medication, measured over At 3 and 6 months.

The primary endpoint is adherence to antidepressant medication, expressed as the percentage of adherence patients. The registry record says adherence was measured through pharmacy records at 3 and 6 months. This makes the endpoint a measure of medication-taking behavior as reflected in those records; the record does not provide further operational details about how a patient was classified as adherent.

Adherence is relevant to the study question because the intervention was designed as pharmaceutical support for antidepressant treatment, and the stated study purpose was to evaluate its impact on compliance and patient wellbeing. A pharmacy-record measure can provide information about medication use recorded by the pharmacy system. It does not, by itself, establish whether medication was taken as directed on each occasion. This is a general distinction between a record-based measure and actual medication-taking behavior.

The endpoint is reported with a 95% confidence interval as its dispersion measure. A confidence interval generally expresses uncertainty around an estimated quantity under the analysis method used. No adherence estimates or confidence limits are reported in the registry record, and the two assessment times are not reduced to one comparison. The size and precision of any observed adherence difference therefore cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The trial is recorded as randomized, double-masked, and parallel. In general, randomization is intended to make treatment groups comparable on average at the point of assignment, while a parallel design assigns each participant to one group for the study. These design labels do not reveal how the random sequence was generated, how assignments were concealed, or who was masked. Those details are not reported in the registry record. The record also does not specify the allocation ratio.

What does the confidence interval describe?

The primary endpoint lists a 95% confidence interval as its dispersion measure. In general, a confidence interval represents uncertainty around an estimate under the assumptions and method of the analysis. It is not a statement that an individual participant's result lies within the interval, and it does not replace the estimate itself. For this trial, no endpoint estimate or interval limits are reported in the registry record, so the precision of the adherence estimate cannot be evaluated.

Why do the two assessment times matter?

Adherence was assessed at 3 and 6 months. In general, repeated measurements can describe outcomes at different points in follow-up, but they also require clarity about which time point or summary is the primary basis for a comparison. The registry record does not reduce the two time points to one comparison and lists 0 analyses. It does not report whether each time point was analyzed separately, whether a combined measure was intended, or how any repeated observations were handled. Those choices should not be inferred.

What can be concluded from the analysis record?

The record names adherence as a numerical outcome and identifies pharmacy records as the measurement source. It does not report the analysis population, the statistical model, adjustment variables, a test statistic, a p-value, or a numerical effect estimate. These omissions mean that neither an unadjusted comparison nor an adjusted one can be reconstructed from the record. No recalculated result is available to interpret.

In general, a p-value evaluates how compatible data are with a specified statistical null model, given the analysis assumptions; it is not a measure of effect size or clinical importance. There is no p-value reported for the primary outcome. Similarly, an effect estimate would describe the magnitude and direction of the group comparison, while its confidence interval would convey uncertainty. Neither is reported for adherence or wellbeing.

How should planning calculations be read?

Any sample-size calculations described as planning illustrations are not the trial's original design justification. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. In general, these are assumptions used to explore planning scenarios; they do not establish what assumptions guided the actual trial.

Such illustrations are not observed power and do not show that a study had a particular probability of detecting an effect after its data were collected. They are conditional on the effect size and other assumptions used for the calculation. The registry record does not report the trial's own sample-size justification, so the illustrative calculations cannot be treated as the protocol's planned enrollment rationale. The record also provides no numerical adherence result from which to assess the observed effect in this interpretation.

Overall, the registry record supports a description of the randomized design and the planned outcome measurement, but not a reconstruction of the statistical analysis. General concepts such as confidence intervals, significance tests, and planning calculations explain what those methods mean; they cannot supply the missing trial-specific estimates or analysis choices.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome was measured at 3 and 6 months, and patient wellbeing was listed as a secondary outcome. Considering multiple outcomes or assessment times can raise multiplicity questions: in general, the more comparisons considered, the more important it is to specify which comparisons are confirmatory and whether any adjustment or prioritization is planned. The registry record does not report a multiplicity strategy, a hierarchy among these outcomes, or a rule for selecting a primary time point. It also does not reduce the adherence time points to one comparison.

The record lists 0 analyses. It does not report whether outcome data were missing, how missing observations were handled, or whether any imputation or sensitivity analysis was used. The number of participants included in each outcome analysis is not reported in the registry record. The enrollment figure alone does not identify the analysis population or establish that all enrolled participants contributed data at both assessment times.

Definitions of analysis populations are also not reported in the registry record. In general, an analysis population describes which participants are included and how they are treated in the analysis; without that information, it is not possible to determine whether the reported comparison followed assignment, included only participants with observed outcomes, or used another approach. These details should not be guessed from the randomized design.

Because outcome estimates and analysis methods are absent, it is not possible to assess the impact of missing data or multiplicity on the results. The record provides no adjusted or unadjusted comparisons for the primary or secondary outcome.

11. 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.

The registry record lists 0 serious adverse events among 92 participants at risk in Usual Care and 0 among 87 participants at risk in the Intervention Group. It also lists 0 other adverse events among 92 participants at risk in Usual Care and 0 among 87 participants at risk in the Intervention Group. These are the recorded event counts and at-risk group sizes.

Zero reported events in these entries means that the registry record lists none in the specified categories and groups. It does not establish that no adverse events occurred outside the recorded categories, that all events were captured, or that the groups have identical safety profiles. In general, interpreting safety counts also depends on how events were defined, collected, and followed; those details are not reported in the registry record.

Death counts are not reported in the registry record. The displayed adverse-event counts do not provide a comparative safety analysis, and the record does not report statistical estimates for differences between groups. These figures should therefore be read as registry-reported counts, not as proof of absence of risk or as a basis for a treatment recommendation.

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

The record establishes that a randomized, double-masked, parallel trial evaluated a pharmaceutical support program added to usual medical and pharmaceutical care. It identifies the primary outcome as antidepressant adherence measured through pharmacy records at 3 and 6 months, with patient wellbeing listed as a secondary outcome. It also records enrollment of 179 and reports the event counts for the two groups.

Those design and outcome details do not reveal the trial's outcome findings. The registry record lists 0 analyses and does not report numerical estimates for adherence or wellbeing. It therefore cannot show whether adherence differed between groups, how large any difference was, or how precisely it was estimated. It also cannot establish whether patient wellbeing differed. No finding of benefit, no finding of no effect, and no claim of equivalent outcomes follows from the absence of reported analyses.

The endpoint itself should be interpreted with care. Pharmacy records were the stated measurement source, but the record does not report the operational threshold used to classify a patient as adherent. In general, a record-based measure describes what is captured in those records and may not fully represent medication-taking behavior. The registry entry does not provide enough detail to judge that distinction for this trial.

The safety counts are limited to the adverse-event entries and denominators reported. They do not establish that the intervention is free of risk or that risks are the same in both groups. More broadly, the registry record is useful for understanding the question and design, but its lack of analysis results places a firm limit on what can be concluded from it.

13. Why This Trial Matters Statistically

This trial raises a useful statistical distinction between a well-defined research question and an interpretable result. The registry record describes a randomized comparison and identifies adherence as the primary outcome, but the listed assessment times are 3 and 6 months and are not reduced to one comparison. Without numerical analyses at those times or a stated summary measure, readers cannot assess the estimated group difference.

The entry also illustrates why outcome definitions and analysis reporting matter. A percentage of adherence patients is a meaningful endpoint description, but the registry record does not give the threshold used to classify adherence or the analysis population. Those details affect the meaning of a percentage and the interpretation of uncertainty. A 95% confidence interval is listed as the dispersion measure, yet no interval or estimate is reported. Naming a statistical summary does not substitute for publishing its value.

The distinction between a planning illustration and the trial's own design assumptions is also important. Planning scenarios based on an observed effect do not establish the original sample-size rationale or observed power. They should not be used to imply that the trial was or was not adequately powered.

Finally, safety counts need their denominators and context. The record reports zero serious and zero other adverse events in each group, but these counts alone do not demonstrate absence of risk or provide a comparative analysis. Taken together, the entry is informative about the intended question, design, and recorded event counts, while its missing outcome analyses sharply limit statistical interpretation.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main trial-specific limitation for interpretation is that the registry record lists 0 analyses and provides no numerical result for either the primary adherence outcome or the secondary wellbeing outcome. The adherence endpoint has two assessment times, 3 and 6 months, and is not reduced to one comparison. The direction, magnitude, and precision of the group comparison therefore cannot be evaluated.

Further details needed to understand the design and results are not reported in the registry record. These include the randomization procedure, allocation ratio, which parties were masked, the operational definition of adherence, the analysis population, statistical methods, missing-data handling, and any multiplicity strategy. The record also does not report the trial's sample-size justification. These omissions should not be filled by assumptions based on common practice.

The safety entries report zero serious and zero other adverse events in both groups, but death counts are not reported in the registry record. The entry does not provide event definitions, collection procedures, or a comparative safety analysis. Accordingly, the counts have a limited descriptive interpretation and do not establish that no events occurred outside the reported entries.

The primary endpoint uses pharmacy records, but the registry record does not explain how those records were translated into the reported percentage of adherence patients. In general, a recorded measure may not capture every aspect of the behavior it is intended to represent. The available description does not permit a more specific assessment of measurement validity for this trial.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care — NCT00794196.
• Registry record last updated 2016-11-22; status last verified 2016-10.
• Results first posted 2016-08-15.
• 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.

18. Record Summary

NCT00794196 is a completed randomized, double-masked, parallel trial sponsored by Fundació Sant Joan de Déu. Its title is Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care. The recorded start was 2008-10, primary completion was 2011-11, and enrollment was 179.

The study compared usual medical and pharmaceutical care with usual care plus a pharmaceutical support program for patients starting antidepressant treatment for depression. The primary outcome was adherence to antidepressant medication measured through pharmacy records at 3 and 6 months; patient wellbeing was listed as a secondary outcome. The registry record lists 0 analyses and reports no numerical outcome estimates. It records zero serious and zero other adverse events in each group; death counts are not reported in the registry record.