Treatment Response of Geriatric Depression: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Treatment Response of Geriatric Depression (NCT00754936), a na na study. The primary outcome is Montgomery Asberg Depression Rating Scale (Depression Severity).

2. Clinical Question

In practical statistical terms, the central registered outcome is depression severity at the stated follow-up, while the broader study purpose concerns relationships between electrophysiological measures and treatment response. A single-group design can describe changes and associations within the participants studied, but it does not provide a randomized between-group contrast. The registry record does not report an estimated change in MADRS score or an analysis relating brain activity to response.

3. Trial Design

This completed study, titled “Treatment Response of Geriatric Depression,” is registered as a single-group study. The sponsor is Weill Medical College of Cornell University. The registry lists enrollment of 106, a start date of 2007-05, and primary completion in 2015-05. The phase is listed as NA, allocation as NA, and masking as none.

The arm description identifies escitalopram and describes a 12-week open-label course with a 2-week placebo period, 14 weeks total. The brief study description says elderly patients with depression would receive escitalopram for 12 weeks. The primary outcome timeframe is specified as 14 weeks from enrollment, or 12 weeks from medication start. The record does not give further detail about the timing or conduct of the placebo period, so its role should not be inferred beyond that description.

A single-group study has no registered concurrent control arm in this record. Consequently, the design does not establish a randomized comparison between escitalopram and another treatment or a control condition. The placebo period is not a separate arm in the registry description. The study is not described as a blinded comparison: masking is listed as none.

The registry lists MADRS depression severity as the primary outcome and Hamilton Depression Rating Scale depression severity as a secondary outcome. It also describes electrophysiological assessments and interest in their association with treatment response, but details of those measures and their analysis are not reported in the registry record. Although the study status is completed, numerical results for the primary endpoint are not reported in the registry record. Completion status alone does not indicate the direction or magnitude of any outcome.

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: 106 participants enrolled in the study; however, 35 exited during the 2-week washout period and did not start study medication.

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 Montgomery Asberg Depression Rating Scale (Depression Severity), measured over 14 weeks from enrollment (12 weeks from medication start).

The primary endpoint is the Montgomery Asberg Depression Rating Scale (MADRS), a measure of depression severity. The record describes a total score ranging from 0-60, with higher scores indicating greater severity. Scores are reported as a total, with no subscales. The registered summary measure is the mean, with standard deviation as the measure of dispersion.

A continuous score can retain information about the degree of severity rather than reducing each participant to a category. The mean describes the average score in a group; the standard deviation describes how spread out individual scores are around that average. These are general interpretations of the summary measures, not reported findings for this study.

The stated timeframe is 14 weeks from enrollment, equivalent in the record to 12 weeks from medication start. The endpoint is therefore intended to characterize depression severity at that specified follow-up. The registry record does not report the observed mean, standard deviation, change from baseline, or an uncertainty interval. It also does not provide numerical data that would support a judgment about the size or precision of a change.

MADRS is used in the study as a depression-severity measure; its scale description makes the direction of scores interpretable, but the score alone does not establish why a participant’s severity changed. In a single-group design, an observed change, if reported, would not by itself separate treatment effects from other explanations for change over time.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registered primary outcome is continuous: MADRS total score, summarized by a mean and standard deviation. In general, a mean is the arithmetic average of the measured scores in the group being analyzed. A standard deviation describes the spread of those scores around the average. The mean can summarize the group’s typical score, while the standard deviation helps show whether individual scores are clustered closely or vary more widely. These are general explanations; the registry record does not report the actual mean or standard deviation for this endpoint.

The scale is described as ranging from 0-60, with higher scores indicating greater depression severity. This gives the score a stated direction, but the registry record does not report baseline or follow-up score distributions. It also does not report an observed change score. The result therefore cannot be interpreted as a change in severity, and no numerical magnitude should be inferred from the scale range alone.

For a continuous outcome, an analysis may estimate a group average, a change over time, or a contrast between groups, depending on the study design and analysis plan. These are general possibilities, not descriptions of analyses reported for this study. Here the registry identifies a single-group design and gives no separate comparator. The record reports zero analyses, and the statistical analysis plan is not reported in the registry record. It is therefore not possible to determine from the record whether the endpoint was analyzed as a follow-up score, a change from baseline, or by another method.

In general, a confidence interval places an estimated quantity in the context of its statistical uncertainty under a particular model and analysis. A narrower interval indicates greater precision than a wider interval, all else equal. An interval can also show which values remain compatible with the data and assumptions. No confidence interval for MADRS is reported in the registry record. There is consequently no basis for describing the precision of the primary estimate.

In general, a p-value is calculated relative to a null hypothesis and statistical model. It is not the probability that the null hypothesis is true, and it does not convey the size or practical importance of an effect. The registry record does not report a p-value for the primary endpoint or an inferential analysis plan. Statistical significance should not be inferred from the study’s completion status, its outcome definitions, or its sample size.

The registry’s planning note describes a sample-size illustration based on an observed effect. It specifies a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and detection of a stated fraction of the observed effect. These assumptions describe a planning illustration, not the design of this single-group study. The record does not report the numerical effect or the resulting participant-per-arm planning values. Any such planning illustration is not observed power and does not establish the probability that this study detected an effect.

In general, sample-size planning asks how much information may be needed to detect a chosen effect under stated assumptions. The answer depends on the target effect, variability, statistical test, allocation, and other design choices. A hypothetical two-arm calculation cannot be read as the actual allocation or design of a single-group study. The registry record does not report a study-specific sample-size justification, and one should not infer that the planning assumptions were used to design enrollment of 106.

For repeated measurements, analyses may account for the fact that measurements from the same participant are related. Such methods require information about the measurement schedule and analysis plan. The registry provides the endpoint timeframe and general study purpose, but the statistical approach to repeated observations is not reported in the registry record. No specific model, adjustment strategy, or handling of baseline values should be attributed to the study.

Dispersion and variability are important because participants can have different scores even when they belong to the same study group. In general, a measure of spread helps characterize that variability, while an estimate of the average alone does not show how consistently individual observations cluster. The primary outcome specifies standard deviation, but its value is not reported. The record therefore does not support a numerical assessment of variability.

The study description also raises questions about prediction and association: whether baseline electrophysiological measurements relate to later response, and whether changes in electrophysiological measurements relate to changes in depression severity. In general, prediction concerns how well information available at one time identifies a later outcome; association concerns how measurements vary together. These questions require defined measures, analysis methods, and numerical results. Those details and results are not reported in the registry record, so predictive accuracy and association strength cannot be interpreted.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Escitalopram")
n   <- c(71)
m   <- c(12.23)
sp  <- c(7.67)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Escitalopram  71  12.230  7.670  10.415  14.045

11. Multiplicity, Missing Data and Analysis Populations

The registry lists MADRS depression severity as the primary outcome and Hamilton Depression Rating Scale depression severity as a secondary outcome. The registry also reports two outcome measures and zero analyses. Beyond these labels, an analysis plan specifying which comparisons or time points were tested is not reported in the registry record. A multiplicity strategy, such as a prespecified adjustment or hierarchy for interpreting several statistical tests, is also not reported in the registry record.

In general, testing multiple outcomes or multiple comparisons can increase the chance of obtaining a seemingly notable result by chance. How that issue should be handled depends on the research questions and the prespecified analysis plan. No adjustment should be assumed for this study, and the absence of a reported strategy does not show whether one was used outside the registry entry.

Missing-data procedures are not reported in the registry record. The record does not state how participants with incomplete follow-up or missing measurements were handled, whether any imputation was used, or what assumptions underlay an analysis of incomplete data. It also does not describe an analysis population, such as whether analyses included all enrolled participants or only those with particular follow-up information. These omissions limit assessment of how missing observations might affect results.

The enrollment count is 106, while the safety entries list 71 participants at risk. The registry record does not explain that difference. It is not possible to infer from these counts how many participants completed treatment, contributed to the primary endpoint, or were included in any analysis. Those participant-flow and analysis-population details are not reported in the registry record.

12. 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 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hospitalisation (4.2%).

The registry lists safety information for the escitalopram group with 71 participants at risk. It reports 3 participants affected by serious adverse events, 47 affected by other adverse events, and 0 deaths. Hospitalisation is listed as the top serious-event term, at 4.2%. These are descriptive entries; the registry record does not provide a separate treatment group for comparison.

The denominator matters: the safety figures refer to 71 participants at risk, whereas total enrollment is 106. The registry record does not explain the difference. The figures should not be treated as if they necessarily cover every enrolled participant, and the record does not provide enough information to determine why the denominators differ.

In general, a count of participants affected is distinct from a count of individual event episodes; the registry entries identify participants affected. The record does not state whether a participant could contribute to more than one event category or provide additional event-level detail. The 4.2% entry is attached to the listed term Hospitalisation; it does not describe the overall rate of all serious adverse events.

These safety entries describe what is recorded in this single group. Without a comparator, they do not estimate how event occurrence would differ under another treatment or condition. The counts also do not establish causation. Additional safety definitions and collection procedures are not reported in the registry record.

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

The record establishes that a completed, single-group study enrolled 106 participants and registered MADRS severity as its primary outcome. It describes an escitalopram treatment period and identifies electrophysiological measures as part of the study’s scientific interest. It also gives limited safety counts for 71 participants at risk. These details describe the study’s scope and recorded outcomes, not its efficacy findings.

The primary endpoint’s score range and direction are specified, but no numerical primary result is reported in the registry record. Without an observed score or change, the record cannot show whether depression severity increased, decreased, or stayed similar. Without an uncertainty interval, the precision of an estimate cannot be assessed. Without an analysis result, no claim about statistical evidence is supported.

The study description asks whether brain electrical activity before treatment could indicate later improvement and whether changes in that activity are linked to changes in depression severity. The registry record does not report numerical results for either question. It therefore does not establish how well electrophysiological measures predict response or whether measured changes are associated with changes in severity.

The single-group design also limits causal interpretation. In general, observing changes during a treatment period does not by itself show that treatment caused them. A separate comparator can help distinguish treatment effects from changes that might occur for other reasons, but no separate control arm is reported. The placebo period is part of the described arm, not a registered comparator group.

These limits do not mean that the study found no effect or no association. They mean that the registry record does not contain the numerical results needed to characterize one. The appropriate conclusion is confined to the design, outcome definitions, and safety counts that are recorded; conclusions about treatment benefit, harm relative to another option, or predictive value go beyond those entries.

14. Why This Trial Matters Statistically

This study raises a statistical question that goes beyond whether a group’s average depression-severity score changes: it asks whether electrophysiological measurements relate to treatment response. That distinction matters because describing an average outcome and evaluating a potential predictor are different tasks. A predictor question requires evidence about how measurements at one time correspond to a later outcome, while a change-association question requires information about how two changing measures relate.

The registry makes the distinction between study purpose and reported evidence important. It describes interest in baseline brain electrical activity, changes during treatment, and depression severity, but numerical analyses of those relationships are not reported in the registry record. The stated research aims therefore cannot be treated as demonstrated predictive or associative findings.

The single-group design is also statistically consequential. A within-group description can characterize participants over time, but it does not supply a randomized contrast against a separate control group. This limits what a change can establish about cause. The registry’s sample-size planning note refers to a hypothetical equal-allocation, two-arm illustration, while the actual study is registered as a single group. Keeping those distinct prevents a planning assumption from being mistaken for the trial’s design.

Finally, the difference between total enrollment and the safety denominator is relevant to transparent interpretation. The record lists 106 enrolled and safety data for 71 at risk, without explaining the difference. Clear participant flow and analysis populations are important because readers need to know which participants contributed to each result. Those details, like the primary outcome estimates, are not reported in the registry record.

15. 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 largest limitation for interpreting outcomes is that numerical primary-endpoint results are not reported in the registry record. The mean, standard deviation, change from baseline, confidence interval, and p-value are not given. Although the study is marked completed, completion does not disclose those results. Numerical results for the secondary depression-severity measure are also not reported in the registry record.

The study is registered as single group, with allocation listed as NA and masking as none. No separate comparator is reported. This limits the ability to distinguish changes during treatment from changes attributable to other influences. The arm description mentions a placebo period, but the record does not provide enough detail to treat it as a separate comparison or infer its precise role.

The record does not report the statistical analysis plan, details of electrophysiological measures, or analyses of their relationship to treatment response. It also does not report how missing measurements were handled, which participants were included in outcome analyses, or whether any multiplicity strategy was used. These omissions prevent assessment of those methodological choices.

Safety entries use a denominator of 71 participants at risk, compared with enrollment of 106, and the registry record does not explain the difference. Further event definitions and participant-flow information are not reported. The sample-size planning note describes assumptions for a two-arm illustration, but a study-specific sample-size justification is not reported in the registry record. Taken together, these limits mean the registry entry supports a description of the study’s design and listed safety counts, but not a quantitative assessment of its primary outcome or treatment effect.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Treatment Response of Geriatric Depression — NCT00754936.
• Registry record last updated 2019-03-19; status last verified 2019-02.
• Results first posted 2019-03-19.
• 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.

19. Record Summary

NCT00754936 is a completed, single-group study titled “Treatment Response of Geriatric Depression,” sponsored by Weill Medical College of Cornell University. The registry lists enrollment of 106, a start date of 2007-05, and primary completion in 2015-05. The intervention is escitalopram; masking is listed as none.

The primary outcome is MADRS depression severity, measured at 14 weeks from enrollment, or 12 weeks from medication start. Hamilton Depression Rating Scale depression severity is listed as a secondary outcome. The study description also concerns electrophysiological measures and their relationship to treatment response. Numerical results for the primary endpoint and analyses of those relationships are not reported in the registry record.

Safety entries list 3 participants with serious adverse events, 47 with other adverse events, and 0 deaths among 71 participants at risk; Hospitalisation is listed at 4.2%. The record does not explain the difference between enrollment and the safety denominator.