This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Trial of Sertraline in Young Children With Autism Spectrum Disorder (NCT02385799), a randomized phase 2 study. The primary outcome is Change in Mullen Scales of Early Learning - Expressive Language Raw Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02385799 |
| Phase | Phase 2 |
| Condition | Autism Spectrum Disorder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 58 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Randi J. Hagerman, MD |
| Results posted | Yes |
2. Clinical Question
Population
Children aged 2 to 5 years inclusive with autism spectrum disorder were eligible. The registry record reports enrollment of 58 participants. At follow-up, 21 placebo-group participants and 26 sertraline-group participants were analyzed, after some participants discontinued treatment and some returned for assessments.
Intervention
The active intervention was liquid sertraline, given once daily for six months. The arm description specifies age-dependent dosing: children aged 2-3 years were assigned 2.5 mg, and children aged 4 years to 6 years were assigned 5 mg. The record identifies the liquid concentration as 20 mg/cc.
Comparator
The comparator was liquid placebo, also given once daily for six months with age-dependent dosing. The description lists 2.5 mg for participants aged 2-3 years and 5 mg for participants aged 4 years to 6 years.
Primary question
The primary outcome was change in the expressive-language raw score on the Mullen Scales of Early Learning from baseline to the six-month visit. The posted record does not report the group changes or a statistical comparison, so it does not establish the size or precision of any difference between the assigned groups.
In statistical terms, the intended comparison is between change over time in the randomized sertraline and placebo groups. The registry describes the study as lasting six months, with testing at the beginning and end. A change-score comparison would ask whether average expressive-language score changed differently between groups across that interval. That is distinct from asking whether either group changed from baseline on its own: within-group change alone would not isolate the contrast associated with assignment.
The clinical context in the registry summary is language and social deficits in children with autism spectrum disorder. However, the named primary outcome is specifically expressive-language raw score. Other listed outcomes include adaptive behavior, anxiety, language, and social participation measures, but the record does not give their results. The central question can therefore be identified, while its empirical answer is not reported in the registry record.
3. Trial Design
The study is identified as phase 2, randomized, triple masked, and parallel group. The registry record gives an enrollment of 58 and marks the study completed. Its stated duration was six months, with assessments at baseline and at the six-month visit. The parallel design means participants were assigned to one of the two treatment groups rather than crossing between treatments during the study.
Random assignment is intended to make treatment groups comparable on average at the point of allocation, including with respect to characteristics that were not measured. Masking is intended to reduce the influence of treatment knowledge on participant or caregiver behavior, clinical assessment, and other aspects of conduct or outcome measurement. The record says masking was triple, but does not specify which roles were masked or how masking was maintained. Those details are not reported in the registry record.
The intervention was liquid sertraline and the comparator was liquid placebo. Both arm descriptions specify daily dosing over six months and an age-dependent dose. The eligibility summary describes children aged 2 to 5 years inclusive, while the arm descriptions refer to ages 4 years to 6 years for the higher listed dose. This difference in age wording is not resolved in the registry record. The active-treatment description also ends mid-sentence, so its full dosing statement is not reported in the registry record.
Follow-up participation differed from enrollment. The registry states that 5 placebo-group participants discontinued treatment and none of them returned for follow-up assessment; 21 were analyzed at follow-up. In the sertraline group, 8 discontinued treatment and 2 returned voluntarily to complete assessments; 26 were analyzed at follow-up. Discontinuing treatment and missing an outcome assessment are not necessarily the same event, and the record does not give individual-level histories or explain how these data were incorporated into an analysis.
The record does not report the randomization procedure, allocation concealment, protocol deviations, or the planned analysis population. A detailed statistical plan, including any covariate adjustment or interim analysis, is not reported in the registry record. The available design labels describe important features, but do not supply enough detail to reconstruct how the primary comparison was intended to be estimated.
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
| Stage | Sertraline Liquid Placebo | Sertraline Active Medication |
|---|---|---|
| STARTED | 26 | 32 |
| Completed End-of-Treatment Visit | 21 | 26 |
| COMPLETED | 21 | 24 |
| NOT COMPLETED | 5 | 8 |
Reasons for not completing this period:
| Reason | Sertraline Liquid Placebo | Sertraline Active Medication |
|---|---|---|
| Lost to Follow-up | 1 | 2 |
| Adverse Event | 4 | 2 |
| Withdrawal by Subject | 0 | 4 |
Analysis population for the primary outcome, as defined in the registry: Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned voluntarily to complete follow-up assessments, so 26 subjects were analyzed at follow-up.
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.
| Characteristic | Unit | Sertraline Liquid Placebo | Sertraline Active Medication | Total |
|---|---|---|---|---|
| Participants analysed | 26 | 32 | 58 | |
| Age, Categorical: <=18 years | Participants | 26 | 32 | 58 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 3.70 (SD 1.10) | 4.31 (SD 0.90) | 4.005 (SD 1.00) |
| Sex: Female, Male: Female | Participants | 5 | 7 | 12 |
| Sex: Female, Male: Male | Participants | 21 | 25 | 46 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 8 | 3 | 11 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 18 | 29 | 47 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 4 | 7 | 11 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 5 | 7 |
| Race (NIH/OMB): White | Participants | 18 | 19 | 37 |
| Race (NIH/OMB): More than one race | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 26 | 32 | 58 |
| The Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) | units on a scale | 7.88 (SD 1.62) | 7.34 (SD 1.58) | 7.58 (SD 1.60) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Mullen Scales of Early Learning - Expressive Language Raw Score, measured over From baseline visit to six-month visit.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in the Mullen Scales of Early Learning expressive-language raw score from baseline to the six-month visit. The Mullen Scales of Early Learning is described as a cognitive test covering gross motor, visual reception, fine motor, receptive language, and expressive language. The reported primary measure focuses on the expressive-language scale, rather than the full set of scales.
The registry describes the expressive-language raw score as ranging from 0 to 50. Lower scores indicate weaker ability and higher scores indicate greater ability. The endpoint is a continuous measure: each participant can have a score within the scale’s range, and a group mean can describe the average score or average change. The record specifies the mean as the summary measure and the standard deviation as its dispersion measure.
A baseline-to-follow-up change measure is used to describe how scores move over the trial interval. Comparing average changes between randomized groups can address whether the groups’ measured trajectories differed, while accounting for the fact that scores are taken at two visits. The outcome is relevant to the stated interest in language development, but a score is a measured test result and does not by itself capture every aspect of communication or daily functioning.
The registry record does not report the group means, mean changes, variability, uncertainty intervals, or a statistical comparison for this endpoint. As a result, the endpoint’s intended role is clear, but the magnitude and precision of the primary result cannot be assessed from the posted record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies the primary outcome and the assessment interval, but does not post the results needed to quantify the primary contrast. There are no reported group mean changes, standard deviations, confidence intervals, or test results for expressive-language raw score. Consequently, the direction, magnitude, and statistical precision of the between-group difference are not reported in the registry record. A numerical treatment effect cannot be inferred from the study design or from follow-up counts.
The participant counts describe who contributed to the follow-up assessment, not how their scores changed. The placebo group had 21 participants analyzed at follow-up after 5 discontinued treatment and none of those 5 returned for follow-up assessments. The sertraline group had 26 analyzed after 8 discontinued treatment, with 2 of those participants returning voluntarily. These counts matter because missing outcome measurements can affect how representative the observed scores are of all randomized participants. They do not show whether missingness altered the result, because no outcome data or missing-data analysis is reported.
Randomization supports a comparison between assigned groups when allocation is preserved and outcomes are analyzed appropriately. It does not guarantee that every participant completes treatment or follow-up, and it does not substitute for reporting the analysis. The record does not state whether the primary analysis followed assignment regardless of treatment discontinuation, used only participants with observed follow-up, or applied another approach. The interpretation of any estimated contrast would depend in part on that choice.
The registry lists 15 outcome measures and 0 analyses. This listing indicates that outcome measures are present in the record, but no analysis results are posted there. The absence of results also means readers cannot assess whether the outcome scale was summarized as planned, whether uncertainty was large or small, or whether the observed pattern was consistent across related measures. Any claims about improvement, lack of improvement, or differences between groups would go beyond the posted outcome data.
The safety record includes separate counts for serious adverse events and other adverse events. Those figures are descriptive observations, not evidence that an event was caused by a treatment. The registry reports no deaths in either group and lists hospitalization for dehydration among the top serious-event terms at 3.1%. The event counts are limited in scale, and the record does not provide a comparative statistical analysis of safety.
Overall, the available information supports description of the trial question, design, follow-up participation, and selected safety counts. It does not support an estimate of the primary treatment contrast. Precision cannot be judged without an effect estimate and its uncertainty, and statistical significance cannot be assessed without the relevant analysis results.
9. Statistical Methods Explained
The registry gives some design and endpoint details, but a statistical analysis plan is not reported in the registry record. The concepts below are general explanations of how such information is commonly interpreted; they are not claims about analyses performed in this trial.
What does a change-score comparison estimate?
For a continuous outcome, a change score represents the follow-up measurement relative to the baseline measurement for a participant. A comparison of average change between randomized groups summarizes how much the groups’ mean trajectories differ over the specified interval. The target is the between-group contrast, not simply whether one group’s score rose or fell. A within-group change can reflect many influences over time, including development, repeated testing, and other events. The randomized comparison is intended to distinguish the groups’ observed trajectories under their assigned study conditions.
The registry identifies the primary measure as a mean and describes standard deviation as the dispersion measure. A mean expresses the average score in a group; a standard deviation describes how spread out individual scores are around that average. These quantities answer different questions. A small standard deviation suggests scores are relatively clustered, while a larger one indicates greater variation. Neither quantity alone gives the uncertainty in the estimated difference between group means.
How should uncertainty be read?
In general, a confidence interval expresses uncertainty around an estimated effect under the assumptions of the analysis. It gives a range of values compatible with the data and method, rather than a guarantee that the true effect falls within that range. Its width is informative about precision: a wider interval indicates less precise estimation than a narrower interval. The registry record does not report a confidence interval for the primary outcome, so precision cannot be judged from the posted results.
A p-value, in general, describes how compatible observed data are with a specified null hypothesis under a statistical model. It does not measure the probability that a treatment works, nor does it express the size or clinical importance of an effect. A p-value should be interpreted alongside an effect estimate, its uncertainty, the outcome definition, and the analysis choices. No primary-outcome p-value is reported in the registry record.
Why do the analysis population and missing outcomes matter?
Analysis populations define which participants contribute to an estimate. An analysis based on assigned groups generally preserves the comparison created by randomization, even when participants stop treatment, if outcomes can still be collected and the estimand is defined accordingly. An analysis limited to participants with observed outcomes can be vulnerable to bias if follow-up availability is related to outcome or treatment experience. Statistical methods can sometimes use incomplete data, but they rely on assumptions about why measurements are missing. The registry does not describe the primary analysis population or a method for handling missing measurements.
Here, the record distinguishes treatment discontinuation from return for follow-up assessment. Some participants who discontinued did not contribute follow-up assessments, while some who discontinued in the sertraline group returned voluntarily. These details show why a simple count of participants who stopped treatment is not enough to describe the primary analysis. The outcome values, reasons for missingness, and analysis approach would be needed to assess possible bias.
What do the sample-size assumptions mean?
General sample-size calculations ask how many participants would be needed to detect a specified effect under stated assumptions about the statistical test, significance level, allocation, and variability. The registry’s stated planning illustration uses a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; it describes the effect to detect as a stated fraction of the observed effect. These are assumptions for an illustration, not evidence about the trial’s original design or its achieved power. The registry does not report the trial’s own sample-size justification.
A planning calculation based on an observed effect must not be read as observed power. Observed power is not a substitute for the estimated effect and its confidence interval; after data collection, precision is better assessed directly through the uncertainty around the estimate. The record does not include the primary effect estimate needed to interpret such a calculation, nor does it report the resulting planning values. The sample-size assumptions therefore do not fill the gap in the primary outcome results.
What can multiplicity and over-dispersion change?
When a study measures several outcomes or conducts several comparisons, the chance of finding at least one apparently unusual result can increase. Statistical plans may address this through prespecified primary outcomes, hierarchical testing, or other multiplicity adjustments. The record lists multiple outcome measures, but does not report a multiplicity strategy. It also does not state whether each measure had one analysis or more than one comparison. These details are important when interpreting a collection of findings, but no collection of outcome estimates is posted.
Over-dispersion is a general concern mainly for count outcomes, when observed variation is greater than a model assumes. It can make standard errors too small if the model does not accommodate that extra variation. The primary outcome in this trial is a continuous score, so count-model over-dispersion is not the central issue for that endpoint. A suitable model would still need to reflect the scale, design, repeated assessments, and missing data. The registry does not report a model specification for the primary analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 15 outcome measures, including repeated entries for several named measures, and reports 0 analyses. It does not explain how the number of measures relates to the planned analysis set, whether entries represent distinct time points or comparisons, or whether a multiplicity adjustment was planned. A prespecified primary endpoint can help distinguish the principal question from secondary analyses, but it does not by itself explain how other comparisons were handled. The multiplicity plan is not reported in the registry record.
Missing follow-up information is relevant to the primary endpoint. In the placebo group, 5 discontinued treatment and none returned for follow-up assessment; 21 were analyzed at follow-up. In the sertraline group, 8 discontinued treatment and 2 returned voluntarily; 26 were analyzed at follow-up. The record does not provide the baseline scores or follow-up scores for these participants, reasons for each missing assessment, or a description of any imputation or other missing-data method.
These follow-up counts should not automatically be treated as the full randomized analysis population. The registry does not say whether the outcome analysis included all randomized participants, only participants with measured outcomes, or another defined group. It also does not report whether treatment discontinuation altered subsequent assessment procedures. Without those details, the effect of missing data on the estimate cannot be assessed.
The record does not report a protocol for controlling multiplicity, the prespecified analysis population, or the handling of missing primary outcomes. Because no primary analysis result is posted, it is also not possible to judge whether secondary findings agree with the primary result or whether conclusions depend on analytic choices.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Sertraline Liquid Placebo | 0 | 26 | 0.0% |
| Sertraline Active Medication | 1 | 32 | 3.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sertraline Liquid Placebo | 0 of 26 |
| Sertraline Active Medication | 0 of 32 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Sertraline Liquid Placebo | 26 of 26 |
| Sertraline Active Medication | 30 of 32 |
Most frequent serious adverse event terms
| Event term | Organ system | Sertraline Liquid Placebo | Sertraline Active Medication |
|---|---|---|---|
| Hospitalization for dehydration | Infections and infestations | 0 of 26 | 1 of 32 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sertraline Liquid Placebo | Sertraline Active Medication |
|---|---|---|---|
| Upper respiratory infection | Infections and infestations | 19 of 26 | 23 of 32 |
| Diarrhea | Gastrointestinal disorders | 15 of 26 | 8 of 32 |
| Hyperactivity | Psychiatric disorders | 9 of 26 | 12 of 32 |
| Irritability/Aggression | Psychiatric disorders | 10 of 26 | 7 of 32 |
| Sleep disturbance | Psychiatric disorders | 3 of 26 | 10 of 32 |
| Fever | Infections and infestations | 7 of 26 | 6 of 32 |
| Gastroenteritis | Gastrointestinal disorders | 5 of 26 | 7 of 32 |
| Vomiting | Gastrointestinal disorders | 3 of 26 | 7 of 32 |
| Otitis media | Infections and infestations | 2 of 26 | 5 of 32 |
| Lethargy | Psychiatric disorders | 4 of 26 | 3 of 32 |
Serious events with the highest arm-level rate: hospitalization for dehydration (3.1%).
The registry reports serious adverse-event counts separately by study group. In the liquid-placebo group, 0 of 26 participants at risk were listed as affected by a serious adverse event; in the sertraline group, 1 of 32 participants at risk was listed as affected. No deaths were reported in either group. The record lists hospitalization for dehydration as a top serious-event term, with 3.1% shown for that term.
These are descriptive counts from the registry. They do not establish that an event was caused by the assigned intervention, and they do not provide a formal comparison of event rates. A small number of observed events can leave substantial uncertainty about differences between groups. The record does not report a statistical safety analysis, detailed event narratives, or an assessment of causality for the listed event.
The record also gives counts for other adverse events: 26 of 26 participants at risk in the placebo group and 30 of 32 in the sertraline group were affected. The categories and definitions behind those totals are not explained in the registry record. Serious events and other adverse events are distinct registry groupings, and the totals should not be treated as interchangeable. The available figures describe reported events during the trial; they do not establish comparative risk beyond those observations.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, triple-masked, parallel-group phase 2 study compared liquid sertraline with liquid placebo in young children with autism spectrum disorder. It also specifies an expressive-language raw-score outcome measured from baseline to the six-month visit. Those details define the research question and the outcome intended to address it.
The record does not post the primary outcome estimates or an analysis. It therefore does not show how much the expressive-language scores changed in either group, how the average changes compared, or how uncertain that comparison was. Neither a beneficial difference nor no difference can be concluded from the information available. In particular, missing reported results should not be interpreted as evidence that the groups were the same.
The follow-up counts do not answer the treatment question. They show that participants’ completion and assessment patterns differed, but they do not reveal their endpoint scores. The safety counts likewise describe reported events rather than proving that the study intervention caused or prevented an event. Both efficacy and safety interpretation would require the relevant outcome data, analysis methods, and uncertainty estimates.
More broadly, a trial result applies to the outcome, participants, interventions, and follow-up that were studied. The primary measure is an expressive-language test score, not every dimension of language, social functioning, or development. The registry’s eligibility summary specifies children aged 2 to 5 years inclusive, and the intervention period is six months. The record does not establish outcomes beyond that age range, for longer follow-up, or for other populations.
Accordingly, the defensible conclusion is about reporting rather than treatment effect: the registry describes the trial design and primary question, but does not report the primary result needed to estimate the contrast between groups. Any stronger conclusion about the measured outcome would require results that are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates a central principle of clinical-trial interpretation: a design can be described in detail while the result remains unavailable for statistical assessment. Randomization, masking, a defined comparator, and a specified outcome clarify what a study set out to compare. They do not provide an effect estimate. Without the primary outcome values or analysis, readers cannot determine the direction, size, or precision of the group contrast.
The record also makes visible the distinction between treatment discontinuation and outcome follow-up. Some participants who stopped treatment did not return for assessment, while some in the sertraline group returned voluntarily. A trial may still collect outcomes after treatment stops, and the chosen analysis can include or exclude those measurements in different ways. Reporting these decisions is essential because the observed follow-up group may differ from the full group originally randomized.
Multiplicity is another statistical issue raised by a record listing numerous outcome measures. When several outcomes are examined, interpretation depends on knowing which analyses were planned and how the primary question was separated from secondary questions. The registry lists measures but does not report an analysis plan or results, so the reader cannot evaluate the pattern across endpoints or the role of multiple testing.
Finally, a planning illustration based on an observed effect is not a substitute for an uncertainty interval around the observed estimate, and it is not the same as the trial’s original sample-size justification. This distinction matters whenever planning calculations are displayed alongside trial results. In this case, the registry’s assumptions are described, but the primary estimate needed to assess precision is not reported.
The statistical importance of the record is therefore methodological: it identifies which information is needed to move from a study description to an interpretable treatment comparison. Effect estimates, uncertainty, analysis populations, missing-data methods, and multiplicity decisions are not optional context; they determine what a reported result can support.
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.
A major limitation for statistical interpretation is that the registry does not report the primary outcome analysis. There are no group-level baseline or follow-up summaries, change estimates, uncertainty intervals, or comparison results. This prevents assessment of both the observed pattern and its precision.
Follow-up participation is incomplete, and the two groups have different reported histories of discontinuation and return for assessment. The registry does not give reasons for missing assessments, outcome values for participants who returned, or an analysis of how missing data were handled. It is therefore not possible to determine whether the analyzed participants represent all randomized participants or whether missingness could have influenced the estimate.
The registry also does not report the detailed statistical plan, including the intended analysis population, the method for estimating change, any adjustment for baseline score, or a strategy for multiple outcomes. The number of listed outcome measures is 15, while the number of analyses is 0; no results are available to assess consistency or selective reporting within the posted record.
Some intervention-description details are unclear. The eligibility summary describes children aged 2 to 5 years inclusive, while the dose descriptions refer to a group aged 4 years to 6 years. The active-medication description ends before its full duration wording is complete. These wording issues limit what can be established from the registry about the exact dosing description for the eligible age range.
The safety information is also limited to counts and a top serious-event term, without a reported comparative analysis or detailed event assessment. These limitations concern what can be concluded from the registry record; they do not establish that the trial itself lacked additional analyses or documentation outside the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Trial of Sertraline in Young Children With Autism Spectrum Disorder — NCT02385799.
- Registry record last updated 2019-10-22; status last verified 2019-10.
- Results first posted 2019-05-09.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT02385799 is a completed phase 2 randomized, triple-masked, parallel-group trial with enrollment of 58. It compared age-dependent daily liquid sertraline with liquid placebo over six months in young children with autism spectrum disorder. The primary outcome was change in Mullen Scales of Early Learning expressive-language raw score from baseline to the six-month visit.
The registry reports follow-up analysis counts of 21 in the placebo group and 26 in the sertraline group, alongside treatment-discontinuation information. It lists 15 outcome measures and 0 analyses. The primary outcome estimates and statistical comparison are not reported in the registry record, so the treatment contrast and its precision cannot be evaluated from the posted results.
Safety entries report 0 serious adverse events among 26 placebo participants at risk and 1 among 32 sertraline participants at risk, with no deaths reported in either group. Hospitalization for dehydration is listed among the top serious-event terms at 3.1%. These figures are descriptive and do not constitute a comparative safety analysis.