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 Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder (NCT00669110), a randomized phase 2 study. The primary outcome is Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00669110 |
| Phase | Phase 2 |
| Condition | Depressive Disorder, Major Depressive Disorder |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Child and adolescent outpatients with major depressive disorder. The registry lists 40 enrolled participants, with safety results reported for 20 children and 20 adolescents.
Intervention
Desvenlafaxine succinate sustained-release tablets, described as DVS SR. The study evaluated flexible dosing over a six-month period.
Comparator
No separate comparator intervention is listed. The registry classifies the study as single group and unmasked; the specific randomization process and any comparator allocation are not reported in the registry record.
Primary question
The primary purpose was to evaluate long-term safety and tolerability. The primary outcome counted participants with adverse events and serious adverse events during the extension study timeframe. Efficacy was a secondary, exploratory aim.
In practical terms, the record asks how many treated participants experienced events during follow-up, rather than whether DVS SR changed symptoms relative to another treatment or control condition. An adverse event did not need to be judged causally related to study treatment to be counted. A serious adverse event was defined by specified consequences, including death, life-threatening events, hospitalization or its prolongation, persistent or significant disability or incapacity, cancer, or a congenital anomaly or birth defect.
The available outcome counts are divided into children and adolescents. That division allows the safety data to be read by the two reported age groups, but it does not establish a randomized comparison between them. The registry record does not report efficacy results or a between-group treatment contrast.
3. Trial Design
This is a phase 2, multicenter, open-label study of DVS SR in child and adolescent outpatients with major depressive disorder. The official title describes a six-month, flexible-dose study intended to evaluate safety, efficacy, and tolerability. The registry lists 40 participants as enrolled, and the study status is completed. The recorded start and primary completion dates are 2008-05 and 2010-05.
The design classifications require careful reading. The registry records allocation as randomized and masking as none, but also identifies the model as single group. One drug intervention is listed, and no separate comparator arm is described. The registry record does not explain how randomization relates to the single-group classification, whether there were distinct enrollment cohorts, or how flexible dosing was assigned. It is therefore not possible to infer a controlled treatment comparison from the word “randomized” alone.
The safety results are presented for children and adolescents, with 20 participants at risk in each group. Those age-group labels describe the posted safety results; the record does not state that participants were randomized between those groups. The primary safety population is described as participants assigned to treatment who received at least one dose during the extension study, with baseline defined as the extension-study baseline.
The primary outcome timeframe runs from baseline in the extension study through the extension study Week 29 follow-up visit. Although the official title describes a six-month study, the record’s outcome timeframe is the more specific wording available for interpreting the posted primary measure. Further details about visit schedules, dose levels, dose changes, adherence, and the relationship of this extension to any earlier study are 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: Baseline (Day-1) in the Extension study = Week 8 (Day 56) in the Core study. However, Baseline for the Clinical Global Impressions Scale - Improvement (CGI-I) = Inpatient Day 1 through 4 in the Core study and Baseline for the Columbia Suicide-Severity Rating Scale (C-SSRS) = Day-1 in the Core study.
Overall Study
| Stage | DVS SR - Children | DVS SR - Adolescents |
|---|---|---|
| STARTED | 20 | 20 |
| COMPLETED | 12 | 7 |
| NOT COMPLETED | 8 | 13 |
Reasons for not completing this period:
| Reason | DVS SR - Children | DVS SR - Adolescents |
|---|---|---|
| Adverse Event | 4 | 3 |
| Caregiver request | 3 | 2 |
| Physician Decision | 0 | 1 |
| Lost to Follow-up | 1 | 0 |
| Protocol Violation | 0 | 5 |
| Withdrawal by Subject | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: Safety population (Baseline=Extension study) includes all treatment assigned participants with at least 1 dose of study treatment during Extension study NCT00669110.
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 | DVS SR - Children | DVS SR - Adolescents | Total |
|---|---|---|---|---|
| Participants analysed | 20 | 20 | 40 | |
| Age, Continuous | years | 9.65 (SD 1.31) | 13.55 (SD 1.64) | 11.60 (SD 2.46) |
| Sex: Female, Male: Female | Participants | 11 | 9 | 20 |
| Sex: Female, Male: Male | Participants | 9 | 11 | 20 |
| Number of participants for Tanner Assessment: Females: Breasts Stage 1 | participants | 4 | 0 | 4 |
| Number of participants for Tanner Assessment: Females: Breasts Stage 2 | participants | 4 | 1 | 5 |
| Number of participants for Tanner Assessment: Females: Breasts Stage 3 | participants | 1 | 0 | 1 |
| Number of participants for Tanner Assessment: Females: Breasts Stage 4 | participants | 0 | 1 | 1 |
| Number of participants for Tanner Assessment: Females: Breasts Stage 5 | participants | 0 | 7 | 7 |
| Number of participants for Tanner Assessment: Females: Pubic hair Stage 1 | participants | 6 | 0 | 6 |
| Number of participants for Tanner Assessment: Females: Pubic hair Stage 2 | participants | 3 | 2 | 5 |
| Number of participants for Tanner Assessment: Females: Pubic hair Stage 3 | participants | 0 | 0 | 0 |
| Number of participants for Tanner Assessment: Females: Pubic hair Stage 4 | participants | 0 | 2 | 2 |
| Number of participants for Tanner Assessment: Females: Pubic hair Stage 5 | participants | 0 | 5 | 5 |
| Number of participants for Tanner Assessment: Males: Penis Stage 1 | participants | 5 | 0 | 5 |
| Number of participants for Tanner Assessment: Males: Penis Stage 2 | participants | 3 | 2 | 5 |
| Number of participants for Tanner Assessment: Males: Penis Stage 3 | participants | 1 | 2 | 3 |
| Number of participants for Tanner Assessment: Males: Penis Stage 4 | participants | 0 | 3 | 3 |
| Number of participants for Tanner Assessment: Males: Penis Stage 5 | participants | 0 | 3 | 3 |
| Number of participants for Tanner Assessment: Males: Pubic hair Stage 1 | participants | 6 | 0 | 6 |
| Number of participants for Tanner Assessment: Males: Pubic hair Stage 2 | participants | 2 | 1 | 3 |
| Number of participants for Tanner Assessment: Males: Pubic hair Stage 3 | participants | 1 | 3 | 4 |
| Number of participants for Tanner Assessment: Males: Pubic hair Stage 4 | participants | 0 | 4 | 4 |
| Number of participants for Tanner Assessment: Males: Pubic hair Stage 5 | participants | 0 | 2 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Adverse Events AEs) and Serious Adverse Events (SAEs), measured over Baseline (Extension study) up to Extension study Week 29 Follow up visit.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with adverse events and serious adverse events. It is a count of people experiencing events, not a count of every event episode and not a measure of symptom improvement. The registry defines an adverse event broadly as an untoward, undesired, or unplanned event, including signs, symptoms, disease, or laboratory or physiologic observations, whether or not it is causally related to treatment.
Serious adverse events are identified by their consequences: death, a life-threatening event, hospitalization or prolonged hospitalization, persistent or significant disability or incapacity, cancer, or a congenital anomaly or birth defect. The endpoint therefore captures both the occurrence of events and a subset meeting the registry’s seriousness criteria. The posted results distinguish the number of participants with serious events from those with other adverse events.
General statistical context: participant counts are useful for describing how many people experienced at least one event within a defined observation period. They do not show how many episodes occurred per person, how long an event lasted, or how severe non-serious events were. Nor does an event count by itself establish that treatment caused the event. A safety endpoint of this kind is used to describe tolerability and identify events requiring attention; interpretation depends on the population, follow-up, event definitions, and completeness of event reporting.
The registry reports the timeframe as baseline in the extension study through the extension study Week 29 follow-up visit. It does not report a risk-adjusted analysis or a comparison with an untreated or alternative-treatment group.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety counts are split between children and adolescents. Among children, 1 of 20 participants had a serious adverse event, and 13 of 20 had other adverse events. Among adolescents, 0 of 20 had a serious adverse event, and 15 of 20 had other adverse events. These are descriptive participant counts during the recorded safety follow-up, not estimates of comparative treatment effects.
The record identifies Negativism (oppositional behavior) as the top serious adverse event term, reported as 5.0%. That term should be read as a registry-listed event category, not as proof of a causal relationship to DVS SR. The adverse-event definition expressly allows events that are not causally related to treatment to be counted. The registry does not provide further detail about event timing, duration, recurrence, severity beyond the serious-event classification, or investigator attribution.
The children and adolescents are not described as comparator arms. Although the allocation field says randomized, the model is listed as single group and the intervention listing contains DVS SR only. The record does not explain this combination. Consequently, differences between the age-group counts cannot be interpreted as a randomized comparison, and there is no listed control group against which to assess the frequency of events.
The primary outcome is safety-focused. The registry describes efficacy as a secondary exploratory aim, but efficacy estimates and analyses are not reported in the registry record. The record lists 16 outcome measures and 0 analyses. It therefore does not support a conclusion about the magnitude, precision, or statistical significance of an efficacy effect.
General statistical context: a participant count gives a direct description of observed events in the people followed, but its precision depends on the number of participants and the observation period. With a small group, a count can change noticeably if the experience of one participant differs. A zero count in a group means no qualifying event was recorded in that group during the stated follow-up; it does not establish that the event cannot occur or that the underlying risk is zero.
No confidence intervals, hypothesis tests, adjusted effect estimates, or formal comparisons are reported in the registry record. The counts should therefore be interpreted as descriptive observations. They do not establish whether an event frequency is higher or lower than it would have been under another intervention, and they do not establish treatment causality.
9. Statistical Methods Explained
The registry describes a participant-count outcome: the number of participants with adverse events and serious adverse events. This type of outcome records whether a participant experienced a qualifying event during follow-up. It differs from an event-rate analysis, which would account for the number of events or time at risk, and from a time-to-event analysis, which would use information about when an event occurred. Neither event rates nor time-to-event results are reported in the registry record.
What a participant count can establish
The posted counts describe observed safety experiences in the safety population and timeframe named in the record. They are straightforward to interpret at the descriptive level: participants are counted if they had an event meeting the relevant definition. The distinction between serious and other adverse events separates events meeting the listed seriousness criteria from those that do not. The record does not provide enough detail to infer whether participants could contribute to both categories, how multiple events in one participant were handled in every outcome, or whether any event coding conventions were used beyond the definitions stated.
General statistical context: a count does not itself quantify uncertainty. A confidence interval, when reported, gives a range of values compatible with the data under a specified statistical method and assumptions. It is not reported for these safety counts. Without an interval or a model-based comparison, the registry results support description of the observed participants but not a precise estimate of how the event frequency might differ in a broader population.
Why group labels matter
The results are separated into children and adolescents, but the design is listed as single group, with one intervention. The record does not describe these age groups as randomized treatment arms. Age-group counts can be presented side by side for descriptive context, but a contrast between them would not be a treatment-effect comparison. Differences could reflect participant characteristics, chance variation, follow-up, or other factors that the registry record does not analyze.
The classification “randomized” appears alongside the single-group model. The record does not explain the randomization procedure or what was randomized. Without those details, the allocation label cannot establish the existence of a control group or support an inference that randomization balances differences between treatment groups.
What inferential analyses are absent
The registry lists 16 outcome measures and 0 analyses. No statistical test, confidence interval, regression model, or adjusted estimate is reported for the primary outcome. No prespecified comparison or inferential analysis of the age-group counts is reported either. The counts should not be treated as statistically significant or nonsignificant findings: no such conclusion is given by a reported test.
General statistical context: an inferential analysis usually requires a defined estimand, a comparison or target quantity, and assumptions about the data and sampling process. For an event outcome, choices can include comparing proportions, modeling counts, or accounting for time at risk. These methods answer different questions. The registry record does not identify a method for estimating a treatment contrast, and the single-group classification offers no listed comparator for such a contrast.
Planning calculations and observed results
The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also states that the effect to detect is a stated fraction of the observed effect. Such a calculation is an illustration of sample sizes under hypothetical planning assumptions, not an observed study result and not observed power. The registry record does not report that these assumptions were the basis of the trial’s design or enrollment target.
The primary outcome contains several categories or time points and is not reduced to one comparison for that planning exercise. No resulting sample-size figures for this primary outcome are reported in the registry record. More generally, a planning estimate depends on the target effect, outcome variability or event frequency, analysis method, and design assumptions. Those inputs cannot be reconstructed from the posted participant counts alone.
General statistical context: over-dispersion matters when count data vary more than a simple count model expects, because a model that understates variability can produce overly narrow intervals or overly optimistic tests. That issue is relevant to some count analyses, but the registry does not report a count model. The primary endpoint is represented as participants with an event, and no model-based estimates are posted. No claim about over-dispersion or model adequacy can therefore be made for this trial.
Likewise, the absence of a reported inferential result is not evidence that a statistical test was negative. It means that the registry record does not report an analysis from which a test result or precision estimate can be interpreted. The most defensible reading is to retain the safety counts as descriptive and avoid converting them into claims about comparative risk, statistical significance, or efficacy.
10. Multiplicity, Missing Data and Analysis Populations
The record lists 16 outcome measures but 0 analyses. It does not report a multiplicity strategy, such as designating a hierarchy of tests, adjusting significance thresholds, or controlling a family-wise error rate. Because efficacy was described as exploratory and the primary measure is safety-focused, the available record does not establish which outcomes were formally tested or how any multiple testing was handled.
General statistical context: examining many outcomes can increase the chance of finding an apparently unusual result by chance if each is tested independently at a conventional threshold. A prespecified analysis plan or adjustment strategy helps readers understand how outcome selection and repeated testing were handled. Neither is reported in the registry record, so no multiplicity-adjusted interpretation can be made.
The safety population is defined as treatment-assigned participants who received at least one dose during the extension study. This is the stated population for the primary measure. The registry does not report the number of participants excluded from that population, the number with incomplete follow-up, or an analysis population for efficacy outcomes.
Missing-data methods, handling of withdrawals, and assumptions about unobserved outcomes are not reported in the registry record. General statistical context: if participants who leave a study differ in event experience from those who remain, a complete-case description may not represent everyone who started treatment. The record does not give enough information to assess whether this issue occurred or how it was addressed. The posted counts should therefore be read as counts for the stated safety population, without assuming that all enrolled participants contributed the same amount of follow-up.
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 |
|---|---|---|---|
| DVS SR - Children | 1 | 20 | 5.0% |
| DVS SR - Adolescents | 0 | 20 | 0.0% |
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 |
|---|---|
| DVS SR - Children | 13 of 20 |
| DVS SR - Adolescents | 15 of 20 |
Most frequent serious adverse event terms
| Event term | Organ system | DVS SR - Children | DVS SR - Adolescents |
|---|---|---|---|
| Negativism (oppositional behavior) | Psychiatric disorders | 1 of 20 | 0 of 20 |
Most frequent non-serious adverse event terms
| Event term | Organ system | DVS SR - Children | DVS SR - Adolescents |
|---|---|---|---|
| Headache | Nervous system disorders | 4 of 20 | 5 of 20 |
| Abdominal pain upper | Gastrointestinal disorders | 4 of 20 | 3 of 20 |
| Somnolence | Nervous system disorders | 1 of 20 | 6 of 20 |
| Nausea | Gastrointestinal disorders | 2 of 20 | 4 of 20 |
| Vomiting | Gastrointestinal disorders | 2 of 20 | 2 of 20 |
| Nasopharyngitis | Infections and infestations | 1 of 20 | 2 of 20 |
| Sinusitis | Infections and infestations | 1 of 20 | 2 of 20 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 2 of 20 | 1 of 20 |
| Joint sprain | Injury, poisoning and procedural complications | 1 of 20 | 1 of 20 |
| Skin laceration | Injury, poisoning and procedural complications | 0 of 20 | 2 of 20 |
Serious events with the highest arm-level rate: negativism (oppositional behavior) (5.0%).
For serious adverse events, the registry reports 1 participant among 20 children and 0 among 20 adolescents. For other adverse events, it reports 13 among 20 children and 15 among 20 adolescents. The record names Negativism (oppositional behavior) as the top serious adverse event term, at 5.0%.
These figures count participants, not the total number of event episodes. An adverse event could be counted even when it was not judged causally related to treatment. Seriousness is based on the consequences listed in the registry definition, rather than on whether an event was considered treatment-related. The record does not provide details about individual event histories or causality assessments.
General statistical context: a zero count means no qualifying serious event was recorded among the adolescents in this safety population and timeframe. It does not prove that such events are impossible or that the underlying risk is zero. The age-group counts are descriptive, and the record does not identify a comparator group or report a statistical comparison. They should not be interpreted as evidence that one age group had a different treatment-related risk from the other.
12. What the Result Does, and Does Not, Mean
The result supports a limited description of safety observations in the registry’s stated population: participants in the child and adolescent groups were reported with serious and other adverse events during extension-study follow-up. The event definitions are broad, and the record makes clear that adverse events did not need to be caused by study treatment to be counted. This is important when distinguishing a report of events during treatment from evidence that treatment caused them.
The record does not establish comparative safety. It lists one intervention and a single-group model, with no separate comparator described. The randomization classification is not explained in relation to that model. Without a reported comparison, the counts cannot show whether event occurrence differed from what would have happened under another treatment or without the intervention.
The record also does not establish efficacy. Efficacy was a secondary exploratory aim, but efficacy analyses and results are not reported in the registry record. The safety outcome cannot stand in for a symptom outcome, and the posted counts do not answer whether depressive symptoms changed.
General statistical context: observed counts are subject to uncertainty, particularly when group sizes are limited. Confidence intervals or other uncertainty measures can help communicate the range of plausible values, but none are reported for these results. The descriptive findings therefore should not be generalized as precise estimates of event frequency beyond the participants and follow-up represented in the record.
In short, the record documents observed event counts in the defined safety population and lists a serious-event term. It does not provide a causal analysis, a controlled comparison, an efficacy estimate, or an inferential assessment. Those absences constrain the conclusions that can be drawn, but they do not change what the registry reports: the numbers of participants recorded with each broad event category.
13. Why This Trial Matters Statistically
This trial is statistically instructive because its registry classifications do not all point to the same design interpretation. Allocation is recorded as randomized, while the model is single group and only one intervention is listed. Recognizing that tension prevents the word “randomized” from being mistaken for evidence of a randomized comparison between DVS SR and a control treatment. The record does not explain the classification combination.
The results also illustrate the distinction between event counts and treatment effects. Counts of participants with adverse events or serious adverse events are useful descriptive safety information. A treatment effect, by contrast, requires a clearly defined comparison and an analysis that estimates how outcomes differ across the relevant conditions. The record reports the former but does not report the latter.
The primary measure’s broad adverse-event definition is another important interpretive feature. Events may be recorded without a causal link to treatment, so occurrence during follow-up is not equivalent to treatment attribution. This distinction applies to many clinical safety records and is particularly important when there is no comparator group to help contextualize background events.
Finally, the registry lists 16 outcome measures but no analyses. That makes it important to distinguish posted descriptive results from a prespecified inferential plan. The record supports transparent reporting of participant counts, while leaving multiplicity, missing-data handling, and efficacy analysis methods unreported. Statistical interpretation should reflect both what is documented and the limits created by what is not.
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 registry record does not explain how the randomized allocation classification fits with the single-group model or the single listed intervention. It does not identify a comparator, detail the randomization procedure, or clarify whether the child and adolescent groups were formed by age rather than allocation. Those missing design details limit interpretation of any apparent differences between the group counts.
The safety results cover the extension-study population and timeframe specified for the primary outcome. The record does not report individual follow-up duration, adherence, dose levels, dose changes, withdrawals, or the number of participants with incomplete outcome data. It is not possible to determine whether all participants were observed for the same duration or how missing safety information was handled.
Event counts are reported without confidence intervals, formal comparisons, adjustment for other factors, or detailed event-level descriptions. The record does not report the number of event episodes, their timing, duration, or causality assessment. The top serious-event term is listed, but further context about its occurrence is not reported in the registry record.
The registry describes efficacy as exploratory but does not report efficacy findings or analysis methods. It also lists 16 outcome measures and 0 analyses, with no reported multiplicity strategy. Consequently, the record does not support conclusions about efficacy, statistical significance, or the precision of safety estimates. These are limitations of the information reported in the registry record, not evidence that unreported procedures or results did or did not exist.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder — NCT00669110.
- Registry record last updated 2021-08-19; status last verified 2021-08.
- Results first posted 2011-05-16.
- 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.
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18. Record Summary
NCT00669110 is a completed phase 2 study of desvenlafaxine succinate sustained-release tablets in child and adolescent outpatients with major depressive disorder. Its official title describes a six-month, multicenter, open-label, flexible-dose study. The registry lists 40 enrolled participants, a randomized allocation classification, no masking, and a single-group model. The sponsor is recorded as Wyeth is now a wholly owned subsidiary of Pfizer.
The primary purpose was to evaluate long-term safety and tolerability, with efficacy as an exploratory secondary aim. The primary measure counted participants with adverse events and serious adverse events from extension-study baseline through the Week 29 follow-up visit. Results are reported for children and adolescents, but comparative analyses and efficacy results are not reported in the registry record.