The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder (NCT00107120), a randomized phase 3 study. The primary outcome is Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group, quadruple-masked, phase 3 study. The registry records 312 participants enrolled and lists Forest Laboratories as sponsor. The study was marked completed. Its stated purpose was a systematic evaluation of escitalopram safety and efficacy in depressed pediatric patients aged 12 to 17 years. The comparison was escitalopram against placebo, with treatment continuing for up to 8 weeks.

The escitalopram regimen began at 10mg once daily for three weeks, with 10-20mg once daily for up to the remaining 5 weeks. The placebo group received placebo once daily for up to 8 weeks. The flexible-dose description matters when interpreting the intervention: the comparison is of the assigned study regimens, not necessarily of one fixed escitalopram dose for every participant throughout treatment.

The primary endpoint was change in CDRS-R total score from baseline to the end of week 8. Efficacy analyses were described as using an Intent-To-Treat Population requiring at least 1 dose of double-blind study drug and at least 1 post-baseline CDRS-R assessment. Missing data were handled using the Last Observation Carried Forward (LOCF) technique. The exact timing and details of any additional visits are not reported in the registry record.

Clinical Global Impressions - Improvement was listed as a secondary outcome, with the score assessed at the end of week 8. The registry reports 3 outcome measures and 3 analyses overall, but the posted secondary outcome information includes only 1 secondary endpoint. Further details of the other outcome measures and the analysis set-up are not reported in the registry record. The original design assumptions, including any sample-size justification, are also 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.

Before assignment: 2 week screening with one-week single-blind placebo. Patients meeting selection criteria at baseline were randomized to once daily escitalopram 10-20mg/day or placebo (1:1).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Efficacy analyses used Intent-To-Treat Population, which consisted of all patients who received at least 1 dose of double-blind study drug \& who had at least 1 post-baseline assessment of the CDRS-R. LOCF technique was used to impute missing data. 1 escitalopram pt. did not have a post-baseline CDRS-R total score.

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 Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score, measured over Baseline to end of week 8.

The primary endpoint measured change from baseline to the end of week 8 in the CDRS-R total score. This scale assesses 17 depressive symptoms. Of these, 3 are rated from 1-5 and 14 from 1-7; the total score ranges from 17-113. The registry describes 1 as indicating no symptom difficulties and 5 or 7 as indicating severe clinically significant difficulties, depending on the item. The endpoint is a continuous measure, so the posted summaries describe average score changes rather than the number of participants meeting a response threshold.

Change scores are used to express how a measured score shifts over the assessment period relative to baseline. In general, examining change can help describe improvement or worsening while accounting for where participants began, although the sponsor’s reported comparison also used an adjusted ANCOVA analysis. A negative change in this scale represents a reduction in total score; the posted mean changes are negative in both groups. The difference between group means is the unadjusted contrast calculated from those arm summaries, while the sponsor’s ANCOVA result is an adjusted comparison.

The endpoint is useful for comparing average symptom-score trajectories under the two assigned regimens, but it does not by itself describe every participant’s experience or establish a clinically meaningful threshold. A group mean can conceal variation among individual outcomes. The registry record does not report a responder definition or a threshold for clinically meaningful change.

7. Results Posted in the Registry

• Escitalopram: mean -22.40 versus -18.40 on control; difference -4.00 (95% CI -7.05 to -0.95), standardized effect d = -0.29; z-test p = 0.010.

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.

Clinical Global Impressions - Improvement

• 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 errors.
• Result:
  • Escitalopram: mean 2.20 versus 2.50 on control; difference -0.30 (95% CI -0.58 to -0.02), standardized effect d = -0.24; z-test p = 0.034.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Escitalopram than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The posted secondary outcome is Clinical Global Impressions - Improvement, measured as a score at the end of week 8. The arm means are 2.2 for escitalopram and 2.5 for placebo; the sponsor also reports an adjusted ANCOVA comparison. The registry record does not describe the score’s direction or specify a threshold for interpreting its magnitude, so the numerical contrast should be considered alongside the scale’s stated purpose rather than assigned a clinical meaning not documented in the record.

At a broad level, the secondary comparison is directionally consistent with the primary result in the sense that its reported mean difference is negative, as is the primary mean difference. The endpoints are different measures, however, and their estimates should not be treated as interchangeable. The secondary result can add context to the overall pattern, but it does not replace the primary endpoint or establish that both measures capture the same aspect of outcome.

Unadjusted secondary results generally carry less weight when the registry does not report how multiple testing was handled. General statistical explanation: evaluating several outcomes can increase the chance that at least one result appears statistically notable by chance. A prespecified outcome hierarchy or an adjustment for multiplicity can address that concern, but neither is reported in the registry record. It is also not reported whether the listed secondary measure was part of a confirmatory testing sequence.

The registry records 3 outcome measures and 3 analyses, while only 1 secondary outcome is posted in the available outcome information. Details about the other outcomes and their results are not reported in the registry record. Consequently, the visible secondary evidence should be regarded as incomplete, and it cannot establish the full pattern across every outcome considered in the study.

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

• Clinical Global Impressions - Improvement

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous, meaning it is measured on a numerical scale and summarized by a mean. The registry reports the mean change in each group together with a standard error. A standard error describes the uncertainty in an estimated mean, rather than the spread of individual participant scores. General statistical explanation: a smaller standard error usually corresponds to a more precise estimate of the group mean, while individual scores can still vary substantially around that mean.

The recalculated primary comparison is an unadjusted difference between the posted group means. The reported means are -22.4 for escitalopram and -18.4 for placebo, and the listed unadjusted mean difference is -4.0. The recalculated confidence interval is -7.049 to -0.951, and the unadjusted p-value is 0.01. This calculation uses the posted summary statistics and does not include covariate adjustment. It is therefore distinct from the sponsor’s reported ANCOVA analysis.

ANCOVA, or analysis of covariance, compares groups while adjusting for covariates included in the model. General statistical explanation: adjustment can account for measured baseline variables and may yield a different estimate and uncertainty from a raw comparison of group means. The registry reports a least-square-means difference for the primary outcome, but the covariates and detailed model specification are not reported in the registry record. The adjusted result should therefore be read as the sponsor’s stated analysis rather than as a model that can be reconstructed from the posted summary information.

A confidence interval gives a range of values compatible with the data under the method’s assumptions. General statistical explanation: it describes uncertainty in the estimate, not the range of individual participant outcomes, and it does not mean there is a specified probability that the true effect lies inside the observed interval. The primary unadjusted interval runs from -7.049 to -0.951. The sponsor’s adjusted primary interval runs from -6.2 to -0.5. Both are intervals for a between-group contrast, but each belongs to a different analysis.

A p-value measures how unusual data at least as extreme as those observed would be if the null hypothesis and analysis assumptions held. It is not the probability that the null hypothesis is true, and it does not quantify clinical importance. The primary unadjusted p-value is 0.01, while the sponsor’s ANCOVA p-value is 0.022. These values are tied to their respective analyses and should not be treated as interchangeable or as direct measures of treatment benefit.

Randomization is intended to make assigned groups comparable in expectation, while masking can reduce the influence of knowledge of assignment on care or assessment. Those are general design purposes, not a guarantee that every potential source of bias is removed. The registry identifies the study as randomized, quadruple-masked, and parallel-group, but it does not report the sequence-generation method, allocation-concealment procedure, or the identities of all roles covered by the masking designation.

The efficacy population required at least 1 dose of double-blind study drug and at least 1 post-baseline CDRS-R assessment. The registry states that 1 escitalopram patient did not have a post-baseline CDRS-R assessment. Thus, the phrase Intent-To-Treat Population is paired with a stated post-baseline assessment requirement; it should not be assumed to mean that every enrolled participant was included in this endpoint analysis. The arm summaries list 154 participants for escitalopram and 157 for placebo.

Missing CDRS-R data were imputed using LOCF. General statistical explanation: LOCF carries a participant’s last recorded score forward to a later time point when a subsequent measurement is missing. This approach can make an analysis possible with incomplete follow-up, but it relies on an assumption that the carried-forward value is a suitable representation of the unobserved outcome. If the underlying outcome would have changed after the last measurement, that assumption may be inaccurate. The registry does not report sensitivity analyses or other missing-data methods, so the robustness of results to alternative assumptions is not reported in the registry record.

The posted secondary comparison also has a continuous outcome and is reported as a mean difference. Its unadjusted result and sponsor-reported ANCOVA result are separate summaries, with the same distinction between an unadjusted calculation and an adjusted model. General statistical explanation: when several outcomes or comparisons are examined, the chance of finding at least one apparently unusual result can increase if each is assessed without accounting for the set of tests. The registry record does not report a multiplicity adjustment or a testing hierarchy, so secondary p-values should be interpreted cautiously.

The planning illustrations use the observed effect as a reference and show participant requirements per arm for specified power targets and effect fractions. General statistical explanation: power is the chance that a planned test will detect an effect of a specified size under its assumptions. A planning calculation is not evidence about the probability that this completed trial detected an effect, and it does not replace the trial’s own design rationale. The original sample-size justification and detailed statistical plan are not reported in the registry record.

11. Confidence Intervals and Precision

The primary unadjusted mean difference is -4.0, with a 95% confidence interval from -7.049 to -0.951. The interval gives a range of plausible values for the unadjusted contrast under the calculation’s assumptions. Its position below zero indicates that the estimated contrast is in the direction of a more negative mean change for escitalopram than for placebo. The interval does not show the range of individual changes, and its width does not tell how clinically important any value in the range would be.

The sponsor’s adjusted ANCOVA estimate is -3.4, with a 95% confidence interval from -6.2 to -0.5. It is also an interval for a between-group contrast, but it arises from an adjusted model rather than the simple recalculation. Since model covariates and further details are not reported in the registry record, the adjusted result cannot be independently reconstructed from the posted arm summaries alone.

Precision depends on the amount and variability of the data and on the analysis method. General statistical explanation: narrower intervals indicate greater precision about the estimated contrast, while wider intervals leave more uncertainty about its possible magnitude. A confidence interval is not a guarantee that the true value lies within its endpoints, and it does not account for every possible source of bias, including missing-data assumptions or selective reporting.

The arm summaries report standard errors of 1.1 for each group. These quantify uncertainty in the reported group means, not the spread of scores among participants. No separate standard deviation for the observed participant outcomes is reported in the arm summaries. The registry record also does not report a clinically meaningful threshold for the CDRS-R contrast, so statistical precision cannot alone determine whether the estimated difference is important in clinical terms.

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, not the trial’s original design calculation. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is the stated fraction of the observed effect. The original trial’s sample-size assumptions are not reported in the registry record.

The 80% power column gives the illustrative participants per arm for a design with an 80% chance of detecting the specified effect under those assumptions. The 90% power column gives the corresponding requirement for a 90% chance. These are prospective planning concepts, not a measure of what happened in this completed trial. This is not observed power.

For the primary comparison, planning for 100% of the observed effect gives 185 participants per arm for 80% power and 248 participants per arm for 90% power. Planning for 75% of the observed effect gives 329 participants per arm for 80% power and 440 participants per arm for 90% power. Planning for 50% of the observed effect gives 739 participants per arm for 80% power and 989 participants per arm for 90% power. The progressively larger requirements illustrate that smaller effects are harder to detect and need more participants, all else held constant.

The curve should be read as a visual version of this planning relationship: required participants rise as the effect to be detected becomes smaller. These illustrations depend on their assumptions and on the observed effect used as the reference; they do not show that the original design was planned in this way or that a particular power level was achieved.

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 = -4.000; pooled standard deviation σ = 13.718.
2. n = 2 × (1.96 + 0.842)² × 13.718² / -4.000² = 184.6, rounded up to 185 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 <- -4                      # observed difference in means
sigma <- 13.7176026097574                     # 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(107120)
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 = 185 (80% power), 248 (90% power)
 75% of observed effect: n per arm = 329 (80% power), 440 (90% power)
 50% of observed effect: n per arm = 739 (80% power), 989 (90% power)
power.t.test: 185.6 
Simulated power at n = 185 per arm: 0.794 (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 sponsor’s primary analysis is an ANCOVA comparison reported as a least-square-means difference of -3.4, with a 95% confidence interval from -6.2 to -0.5 and p = 0.022. The simple recalculation from the posted group means is an unadjusted difference of -4.0, with a 95% confidence interval from -7.049 to -0.951 and an unadjusted p-value of 0.01. The sponsor’s estimate and the recalculated estimate are not identical because the analyses differ: ANCOVA adjusts for model covariates, while the recalculation uses the arm summaries without adjustment.

The registry record does not state the ANCOVA covariates or enough model detail to reproduce the sponsor’s result. The sponsor’s own analysis is therefore the reported adjusted analysis, while the recalculation is a transparent summary-statistic comparison and should not be mistaken for the sponsor’s model. The registry record does not flag a discrepancy for the primary comparison.

For the secondary outcome, the sponsor reports an ANCOVA least-square-means difference of -0.344 and p = 0.008. That result likewise represents an adjusted analysis, distinct from the unadjusted calculation. Interpretation of secondary testing also depends on whether multiple comparisons were addressed, which is not reported in the registry record.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when statistical conclusions are drawn from several outcomes, comparisons, time points, or analysis choices. General statistical explanation: as the number of unadjusted tests grows, the chance of at least one apparently notable result under a collection of null hypotheses can rise. A prespecified hierarchy or a statistical adjustment can help control this issue, but the registry record does not report whether either approach was used.

The primary endpoint is identified as change in CDRS-R total score from baseline to the end of week 8, and the sponsor reports an ANCOVA analysis for it. The registry does not report a complete statistical analysis plan, a testing hierarchy, or a multiplicity adjustment. It is therefore not possible to determine from the record whether the secondary p-value was intended as confirmatory, whether other outcomes were tested, or how any family of tests was handled.

Missing data were addressed using LOCF for the efficacy analysis. The record defines the analysis population as patients receiving at least 1 dose of double-blind study drug and having at least 1 post-baseline CDRS-R assessment; it also states that 1 escitalopram patient lacked a post-baseline CDRS-R assessment. This definition and imputation method should be considered together: the reported endpoint analysis does not simply include every enrolled participant regardless of post-baseline outcome availability.

General statistical explanation: LOCF substitutes a participant’s last recorded value for a later missing value. Its suitability depends on how outcomes evolve after the last observation and on why data are missing. The registry record does not report the reasons for missing assessments, the amount of missingness at each visit, sensitivity analyses, or alternative imputation methods. It is therefore not possible to assess from the record how strongly the estimates depend on the LOCF assumption.

The record also does not report interim analyses, stopping rules, or a detailed account of all planned versus reported analyses. Those items should not be inferred from the completed status or from the posted endpoint results. The absence of these details limits assessment of analysis flexibility and the completeness of outcome reporting.

16. Safety Results

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

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: inflicted injury (1.3%), irritability (0.6%), suicidal tendency (0.6%), depression aggravated (0.6%).

The registry reports serious adverse events affecting 4 participants in the escitalopram group and 2 in the placebo group. The listed serious-adverse-event populations at risk were 155 and 157, respectively. These are descriptive counts from the safety information; they do not by themselves establish a comparative safety effect, and they do not convey severity, timing, relatedness, or whether any participant experienced more than one event.

The registry also lists other adverse events affecting 121 participants in the escitalopram group and 118 in the placebo group, with the same respective populations at risk of 155 and 157. These other-event figures should be kept separate from the serious adverse-event counts. The serious-event terms listed include Inflicted Injury at 1.3%, Irritability at 0.6%, Suicidal Tendency at 0.6%, and Depression Aggravated at 0.6%; the record does not clarify the group attribution for these listed percentages.

Deaths are not reported in the registry record. The safety summaries are limited to the posted counts and terms; details such as event onset, duration, causal assessment, and participant-level overlap are not reported in the registry record. These figures describe recorded events during the study and are not, on their own, a full account of safety.

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

The posted primary results describe average CDRS-R change through the end of week 8 for the recorded escitalopram and placebo groups. Both group means show negative change. The unadjusted contrast is -4.0, and the sponsor’s adjusted ANCOVA contrast is -3.4. Their confidence intervals quantify uncertainty under their respective analyses, but the registry does not provide a threshold that defines a clinically meaningful difference on this endpoint.

These results do not establish how every participant changed. A mean summarizes a group and can coexist with a range of individual experiences. The registry record does not provide distributions, responder counts, or a responder definition for the primary outcome. It is therefore not possible to infer from the mean difference how many participants experienced a particular level of change.

The findings are specific to the study’s stated pediatric population, flexible-dose escitalopram regimen, placebo comparison, and week 8 outcome. They do not determine longer-term outcomes, outcomes in age groups outside 12 to 17 years, or results under other regimens. The open-label extension mentioned in the study summary is not represented by the posted primary comparison.

A statistical result is not a treatment recommendation. The p-values do not measure the probability that an effect is real or clinically important, and they do not account for every limitation in study conduct or reporting. Interpretation also depends on missing-data handling, the adjusted model details, outcome selection, and whether multiplicity was addressed; several of these details are not reported in the registry record.

The safety information is similarly bounded. Counts of participants with serious and other adverse events describe the recorded events, but do not provide a complete comparison of event severity, cause, timing, or longer-term risk. The registry record should be read as a report of specified outcomes and analyses, not as a complete account of all possible effects.

18. Why This Trial Matters Statistically

This trial offers a useful statistical example of how a randomized comparison can be reported through both group summaries and an adjusted model. The primary arm means describe observed average change, while the unadjusted recalculation expresses their contrast directly. The sponsor’s ANCOVA estimate answers a related question after model adjustment. Keeping those analyses distinct helps prevent a summary-statistic calculation from being mistaken for the trial’s reported adjusted analysis.

The study also illustrates why an endpoint definition and analysis population matter. The CDRS-R is a continuous symptom score assessed from baseline to week 8, and the efficacy population required treatment exposure and at least 1 post-baseline assessment. The stated LOCF approach further shapes how missing endpoint data enter the analysis. These features are essential context for interpreting a mean difference and its confidence interval.

Precision and statistical significance are not the same as clinical importance. The confidence intervals communicate uncertainty in the estimated group contrast, while the registry does not supply a threshold for meaningful change. A p-value cannot fill that gap. Likewise, a secondary result should be considered in relation to the primary outcome and the unreported multiplicity strategy rather than treated as independent confirmation.

Finally, the record makes visible the distinction between outcome reporting and trial design information. It describes randomization, masking, treatment regimens, an endpoint, and an analysis approach, but does not report several elements needed for a full statistical audit, including original sample-size justification, detailed ANCOVA covariates, and sensitivity analyses for missing data. Recognizing both the reported evidence and these limits is central to responsible interpretation.

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 does not report the original sample-size justification or the assumptions used to plan enrollment. The planning illustrations based on the observed effect are not a substitute for that information. The record also does not explain the random sequence-generation or allocation-concealment procedures, or identify the roles included in quadruple masking.

The sponsor’s ANCOVA covariates and detailed model specification are not reported, so its adjusted primary estimate cannot be reproduced from the posted summaries. The registry also does not report the full statistical analysis plan, multiplicity procedures, an outcome hierarchy, or interim-analysis information. The posted record lists 3 outcome measures and 3 analyses, but only 1 secondary outcome is described in the posted outcome information.

The efficacy analysis used LOCF, but reasons for missing assessments, missingness by time point, and sensitivity analyses are not reported. The efficacy population required at least 1 post-baseline assessment, and the record notes that 1 escitalopram patient did not have one. These details limit assessment of how missing outcomes may affect the reported estimates.

The primary outcome is summarized by group means and standard errors, without a reported clinically meaningful threshold or responder definition. The secondary score’s interpretation and threshold are also not described. The safety record gives event counts and selected terms but does not report event timing, causal assessment, duration, or participant-level overlap; deaths are not reported in the registry record.

Finally, the primary endpoint concerns the end of week 8. The posted results do not establish longer-term outcomes, and the open-label extension mentioned in the study summary is not described by these comparisons. These limitations define what can and cannot be concluded from the registry record.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder — NCT00107120.
• Registry record last updated 2012-04-06; status last verified 2012-04.
• Results first posted 2009-11-04.
• 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

The registry describes a completed, randomized, parallel-group, quadruple-masked phase 3 study sponsored by Forest Laboratories. It enrolled 312 pediatric patients with major depressive disorder, aged 12 to 17 years, and compared flexible-dose escitalopram with placebo for up to 8 weeks.

The primary outcome was change in CDRS-R total score from baseline to the end of week 8. The posted mean changes were -22.4 for escitalopram and -18.4 for placebo. The unadjusted recalculation gives a mean difference of -4.0; the sponsor’s ANCOVA analysis reports -3.4. The registry also posts Clinical Global Impressions - Improvement as a secondary outcome.

The efficacy analysis used a defined Intent-To-Treat Population and LOCF for missing data. The registry record does not report the original sample-size justification, detailed adjusted-model covariates, or multiplicity and sensitivity-analysis procedures. Safety figures and their limits should be interpreted as descriptive registry results.