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 Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression (NCT01098240), a randomized phase 2 study. The primary outcome is Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01098240 |
| Phase | Phase 2 |
| Condition | Major Depressive Disorder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 297 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Participants with major depressive disorder receiving antidepressant therapy were the population of interest. The primary analysis population is described as the full analysis set: participants who consumed at least one dose of randomized study medication. The registry record does not report detailed eligibility criteria or participant characteristics in the registry record for this analysis.
Intervention
CP-601,927 was studied as an augmentation to antidepressant therapy. The record identifies an active-treatment group receiving CP-601,927 + ADT, but does not report the dose or other medication-use details in the registry record.
Comparator
The comparator was placebo added to antidepressant therapy. The randomized design was double-blind and parallel. Details about how antidepressant therapy was selected or managed are not reported in the registry record.
Primary question
The primary question concerned change in total Montgomery-Asberg Depression Rating Scale (MADRS) score from double-blind baseline to the recorded Week 14 endpoint. The registry record does not provide a single numerical comparison or an inferential result for that endpoint, so the relative change between groups cannot be determined from the posted results.
This is a question about the added treatment in the context of ongoing antidepressant therapy, rather than CP-601,927 used alone. The stated primary objectives included evaluating efficacy using MADRS and evaluating safety and tolerability. The registry lists a number of additional symptom, global-impression, irritability and disability outcomes at several time points. Those measures broaden the clinical questions, but they do not replace the primary endpoint or provide a missing primary comparison.
3. Trial Design
The study is identified as a randomized phase 2a trial with double masking, a parallel-group model and placebo control. Its stated purpose was to evaluate CP-601,927 augmentation of antidepressant therapy in major depressive disorder. The trial record lists an enrollment of 297. Enrollment is a study-level figure and should not be treated as the analyzed number for each outcome or as the number with evaluable primary-endpoint data.
The record identifies CP-601,927 and placebo as interventions, with groups described as CP-601,927 + ADT and Placebo + ADT in the adverse-event data. It also contains an Open-Label ADT adverse-event group. The registry entries available do not explain the relationship of that group to the randomized treatment period or provide enough detail to infer allocation among groups. The stated primary analysis population was the full analysis set, defined as participants who consumed at least one dose of randomized study medication.
The recorded study start date is 2010-06-14, and the primary completion date is 2011-09-12. The study status is terminated. The reason for termination, the date of termination, and whether termination affected planned analyses are not reported in the registry record. The record identifies secondary outcomes assessed over various weeks, including MADRS, HAM-D25, Bech Melancholia, CGI-S, SIS, SDS and CGI-I measures. It does not provide detailed treatment procedures, adherence information, site information, or a full account of the timing of visits in the registry record.
Randomization and masking are design features intended to reduce systematic differences and expectations that could influence comparisons. They do not by themselves establish what the results were, how missing observations were handled, or whether the reported analysis followed a prespecified plan. Those details 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.
Open-Label Phase
| Stage | Open-Label Antidepressant Treatment (ADT) | CP-601,927 + ADT | Placebo + ADT |
|---|---|---|---|
| STARTED | 297 | 0 | 0 |
| COMPLETED | 162 | 0 | 0 |
| NOT COMPLETED | 135 | 0 | 0 |
Reasons for not completing this period:
| Reason | Open-Label Antidepressant Treatment (ADT) | CP-601,927 + ADT | Placebo + ADT |
|---|---|---|---|
| Study Terminated by Sponsor | 27 | 0 | 0 |
| Protocol Violation | 4 | 0 | 0 |
| Lost to Follow-up | 13 | 0 | 0 |
| Other | 19 | 0 | 0 |
| Did Not Meet Entrance Criteria | 50 | 0 | 0 |
| Pregnancy | 1 | 0 | 0 |
| Withdrawal by Subject | 9 | 0 | 0 |
| Adverse Event | 12 | 0 | 0 |
Double-Blind Phase
| Stage | Open-Label Antidepressant Treatment (ADT) | CP-601,927 + ADT | Placebo + ADT |
|---|---|---|---|
| STARTED | 0 | 77 | 85 |
| COMPLETED | 0 | 60 | 63 |
| NOT COMPLETED | 0 | 17 | 22 |
Reasons for not completing this period:
| Reason | Open-Label Antidepressant Treatment (ADT) | CP-601,927 + ADT | Placebo + ADT |
|---|---|---|---|
| Study Terminated by Sponsor | 0 | 5 | 8 |
| Protocol Violation | 0 | 2 | 4 |
| Lost to Follow-up | 0 | 2 | 0 |
| Other | 0 | 2 | 2 |
| Did Not Meet Entrance Criteria | 0 | 1 | 0 |
| Insufficient Clinical Response | 0 | 1 | 2 |
| Withdrawal by Subject | 0 | 1 | 3 |
| Adverse Event | 0 | 3 | 3 |
Analysis population for the primary outcome, as defined in the registry: The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. Number Analyzed = number of participants with evaluable data at each timeframe.
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 | Open-Label ADT |
|---|---|---|
| Participants analysed | 297 | |
| Age, Customized: 18 to 44 years | Participants | 113 |
| Age, Customized: 45 to 64 years | Participants | 181 |
| Age, Customized: Greater than or equal to (>=) 65 years | Participants | 3 |
| Sex: Female, Male: Female | Participants | 220 |
| Sex: Female, Male: Male | Participants | 77 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14, measured over Week 8 (double-blind baseline ) and week 14 (week 6 of double-blind phase).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in total MADRS score from double-blind baseline to Week 14. MADRS is a rating scale for overall depressive-symptom severity. The registry describes it as a 10-item checklist, with each item rated from 0 to 6 and a total score ranging from 0, where depressive symptoms are absent, to 60, the numerically highest level of symptoms.
A continuous score retains gradations across the scale rather than reducing participants to a binary category. Comparing change over time can describe how the measured symptom score differs between treatment groups during the study. The record says the endpoint is a mean and that standard deviation is the dispersion measure. A mean describes the group average; a standard deviation describes the spread of individual scores around that average. Neither one alone conveys the uncertainty around a treatment-group contrast.
The registry labels the primary endpoint as Week 14, while its timeframe describes Week 8 as double-blind baseline and Week 14 as week 6 of the double-blind phase. These labels are reported as recorded; their relationship is not clarified in the registry record. The record does not give the group means, mean changes, treatment contrast, confidence interval or p-value for the primary endpoint. It also does not state the sign convention used to calculate change. Therefore, the endpoint definition can be described, but the magnitude and precision of the primary comparison cannot be assessed from the posted results in the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive limitation is that the registry record does not provide a single numerical primary-outcome comparison. It identifies the primary measure, its scale and the analysis population, but the registry entries available do not include group-level endpoint results, an estimated between-group effect, a confidence interval or a p-value. Without those results, there is no basis in this record for describing the size, direction or statistical precision of a difference in MADRS change between CP-601,927 + ADT and Placebo + ADT.
The record notes that the primary outcome has several categories or time points and was not reduced to one comparison. That means a single headline contrast is not available in the listed analysis information. This does not establish that no analysis was conducted; it means the registry information does not furnish one result that can be interpreted as the trial's primary estimate. The analysis count is recorded as zero, and the registry status is terminated, but neither fact explains why the outcome comparison is absent or what analyses may have been conducted outside the posted record.
When interpreting a continuous endpoint, the mean change and a treatment-group contrast answer different questions. A within-group change describes movement from baseline in one group; the contrast compares that movement between groups. A confidence interval, when reported, expresses the range of values reasonably compatible with the estimated contrast under the analysis assumptions. A p-value addresses compatibility with a specified null model, not the size or clinical importance of an effect. None of these primary-comparison quantities is reported in the registry record.
The listed secondary outcomes cover symptom scales, global impressions, irritability and disability, with assessments scheduled at multiple weeks. They are not substitutes for the primary endpoint, and their presence alone does not establish consistent findings. Numerical secondary-outcome results and their analysis details are not reported in the registry record in the registry record. No conclusion about efficacy should be drawn from the endpoint list alone.
Similarly, the adverse-event counts describe recorded safety observations, not a causal treatment effect. The group-specific counts can be read as descriptive counts with their recorded at-risk denominators, but the record does not provide a comparative safety analysis, uncertainty estimates or adjustment for differences in exposure. Serious-event terms are also listed with percentages without group attribution in the registry record. These data therefore support a description of what was recorded, not a definitive comparison of safety between treatments.
9. Statistical Methods Explained
The available record gives important elements of the design and endpoint definition, but it does not report a complete statistical analysis plan. The trial is described as randomized, double-blind and parallel-group, and the primary outcome is a continuous mean score. These details identify the broad framework for comparing groups; they do not identify the exact statistical model, covariates, assumptions, missing-data procedure or multiplicity strategy.
What does a mean change describe?
A mean change summarizes the average movement in a continuous measure for a group over the specified assessment period. A treatment comparison typically focuses on the difference between the groups' changes, rather than treating each within-group change as proof of a treatment effect. The registry identifies the endpoint as a mean and gives standard deviation as its dispersion measure. Standard deviation describes variation among observed scores. It is not the same as a standard error or a confidence interval, which concern the precision of an estimated mean or contrast.
The MADRS range is described as 0 to 60, with 0 indicating absent depressive symptoms and 60 indicating the numerically highest symptom level. This tells readers how the score is oriented as a severity measure. However, the record does not specify the arithmetic convention for change, such as whether follow-up minus baseline or baseline minus follow-up was used. Without that convention and without the group estimates, a numerical direction cannot be interpreted from the record.
Why does the analysis population matter?
The primary analysis population is described as the full analysis set: participants who consumed at least one dose of randomized study medication. The registry also explains that the number analyzed is the number with evaluable data at each timeframe. These statements distinguish the defined analysis population from the available observations for a particular endpoint assessment. The number with evaluable data can vary by timeframe; the record does not give the primary endpoint's analyzed count by group in the registry record.
Different analysis populations can answer somewhat different questions. A population based on randomized assignment may preserve the advantages of randomization, while a population requiring treatment exposure or evaluable data can depend on post-randomization events. This is general statistical context, not a claim about the analysis conducted in this trial beyond the stated full-analysis-set definition. The registry record does not report additional analysis populations or explain whether sensitivity analyses were performed.
What does uncertainty add?
A point estimate alone describes the estimated effect under a chosen analysis. A confidence interval adds information about precision by showing a range of values compatible with the data and model at the stated confidence level. A wide interval can indicate substantial uncertainty; a narrow interval indicates greater precision under the same assumptions. A p-value, if reported, addresses compatibility with a null hypothesis and should not be read as the probability that a treatment effect is true. The registry entries include no primary treatment estimate, confidence interval or p-value, so precision and statistical significance cannot be evaluated.
What do the planning assumptions mean?
The record describes a sample-size planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. The target effect is stated as a fraction of the observed effect. Such planning values are hypothetical estimates of participants per arm under those assumptions; they are not observed trial results and are not observed power. The record does not report the trial's own sample-size justification. The planning illustration should not be taken as evidence that the trial was designed around those assumptions or that its actual analysis used the same methods.
More generally, power calculations depend on assumptions about the target effect, variability, allocation, significance threshold and analysis. A planning calculation based on an observed effect can be especially dependent on the estimate used. Since the registry entries do not give the observed primary effect or the numeric planning outputs, no trial-specific assessment of those calculations can be made.
What does the multi-timepoint outcome mean for analysis?
The primary outcome is named at Week 14, but the recorded timeframe describes Week 8 as double-blind baseline and Week 14 as week 6 of the double-blind phase. Several secondary outcomes also have multiple assessment weeks. Repeated assessments from the same participant are generally statistically related, so an analysis of repeated measurements may need to account for that dependence. This is general explanation only: the statistical model used for this trial is not reported in the registry record.
When outcomes are examined at multiple time points or across multiple measures, the number of statistical questions can grow. Multiplicity procedures can be used to control the chance of misleading positive findings across a family of tests. The registry record does not report a multiplicity adjustment, a hierarchy of tests or other details that would establish how multiple comparisons were handled. The primary outcome is explicitly not reduced to one comparison in the available analysis information, so there is no single estimate to which those considerations can be applied.
Why can over-dispersion matter?
For count data, over-dispersion means that the observed variability is greater than a simple statistical model expects. If ignored, uncertainty can be understated and tests can appear more conclusive than warranted. This is general statistical context; the primary endpoint in this trial is continuous rather than a count, and the registry entries available do not identify an over-dispersion issue or a model for count outcomes. The safety counts should therefore be read descriptively rather than as a fitted comparative analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome and multiple secondary measures, some assessed at more than one time point. That creates more than one possible statistical comparison. When many outcomes or time points are tested, the chance of at least one apparently notable finding can increase. Statistical plans may address this through a prespecified hierarchy, adjustment, or a clearly exploratory interpretation. The registry record does not report whether any such approach was specified or used. The primary outcome is recorded as having several categories or time points and is not reduced to a single comparison in the available analysis information.
Missing-data handling is also important for change from baseline. The record defines the full analysis set as participants who consumed at least one dose of randomized study medication, and says the number analyzed is the number with evaluable data at each timeframe. It does not report the number with evaluable primary outcome data by treatment group, the amount or reasons for missingness, or the method used to handle missing observations. It also does not report sensitivity analyses assessing whether conclusions would change under different missing-data assumptions.
These omissions limit assessment of possible bias and precision. If the availability of follow-up scores is related to a participant's health or treatment experience, an analysis restricted to observed data can differ from the result that would have been obtained with complete data. This is a general concern, not a claim that missingness was related to outcomes in this trial. The registry record does not provide enough information to evaluate that possibility or to determine whether the planned analysis addressed it.
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 |
|---|---|---|---|
| Open-Label ADT | 3 | 297 | 1.0% |
| CP-601,927 + ADT | 1 | 77 | 1.3% |
| Placebo + ADT | 1 | 85 | 1.2% |
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 |
|---|---|
| Open-Label ADT | 210 of 297 |
| CP-601,927 + ADT | 58 of 77 |
| Placebo + ADT | 61 of 85 |
Most frequent serious adverse event terms
| Event term | Organ system | Open-Label ADT | CP-601,927 + ADT | Placebo + ADT |
|---|---|---|---|---|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 297 | 1 of 77 | 0 of 85 |
| Suicide attempt | Psychiatric disorders | 0 of 297 | 0 of 77 | 1 of 85 |
| Atrial fibrillation | Cardiac disorders | 1 of 297 | 0 of 77 | 0 of 85 |
| Pneumonia | Infections and infestations | 1 of 297 | 0 of 77 | 0 of 85 |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | 1 of 297 | 0 of 77 | 0 of 85 |
| Suicidal ideation | Psychiatric disorders | 1 of 297 | 0 of 77 | 0 of 85 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Open-Label ADT | CP-601,927 + ADT | Placebo + ADT |
|---|---|---|---|---|
| Headache | Nervous system disorders | 42 of 297 | 16 of 77 | 12 of 85 |
| Nausea | Gastrointestinal disorders | 39 of 297 | 11 of 77 | 12 of 85 |
| Insomnia | Psychiatric disorders | 24 of 297 | 10 of 77 | 10 of 85 |
| Diarrhoea | Gastrointestinal disorders | 28 of 297 | 4 of 77 | 5 of 85 |
| Fatigue | General disorders | 18 of 297 | 3 of 77 | 13 of 85 |
| Upper respiratory tract infection | Infections and infestations | 24 of 297 | 6 of 77 | 4 of 85 |
| Dizziness | Nervous system disorders | 22 of 297 | 5 of 77 | 4 of 85 |
| Dry mouth | Gastrointestinal disorders | 17 of 297 | 4 of 77 | 8 of 85 |
| Somnolence | Nervous system disorders | 18 of 297 | 4 of 77 | 4 of 85 |
| Irritability | General disorders | 12 of 297 | 2 of 77 | 5 of 85 |
Serious events with the highest arm-level rate: thyroid cancer (1.3%), suicide attempt (1.2%), atrial fibrillation (0.3%), pneumonia (0.3%), pregnancy (0.3%).
The adverse-event record lists an Open-Label ADT group with 3 serious adverse events among 297 participants at risk and 210 participants affected by other adverse events among 297 at risk. For CP-601,927 + ADT, it lists 1 serious adverse event among 77 at risk and 58 affected by other adverse events among 77 at risk. For Placebo + ADT, it lists 1 serious adverse event among 85 at risk and 61 affected by other adverse events among 85 at risk. These are descriptive registry counts and denominators; they are not, by themselves, estimates of a causal treatment effect.
The record's list of serious adverse-event terms includes Thyroid cancer (1.3%), Suicide attempt (1.2%), Atrial fibrillation (0.3%), Pneumonia (0.3%), Pregnancy (0.3%) and Suicidal ideation (0.3%). The registry entries available do not attribute these listed terms to a particular group or clarify the denominator used for each listed percentage. Deaths are recorded as null, so a death count is not reported in the registry record.
These figures do not indicate timing, duration, event severity beyond the serious-event classification, or exposure-adjusted rates. The record does not provide a statistical comparison or uncertainty estimates for adverse events. Counts across groups should therefore be interpreted in their recorded context, without treating numerical differences as evidence of a treatment-related increase or decrease.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized, double-blind comparison of CP-601,927 added to antidepressant therapy against placebo added to antidepressant therapy. It defines a primary outcome based on change in MADRS total score and identifies the intended analysis population. This information establishes what the study set out to assess and how the main measure was characterized.
It does not establish the size or direction of the primary treatment comparison. Group means, a between-group estimate, a confidence interval and a p-value are not reported in the registry record. The primary outcome is also described as involving several categories or time points and is not reduced to one comparison. Without a reportable primary estimate, this record cannot show how precisely the trial distinguished the groups on MADRS change.
The endpoint's scale helps interpret its clinical measurement: lower scale values correspond to less symptom severity in the scale description, while higher values correspond to greater severity. But interpreting a change score requires knowing the sign convention, and that convention is not reported. The Week 14 label and the timeframe's description of Week 8 baseline and Week 14 as week 6 of the double-blind phase are both retained in the record; their apparent timing relationship is not clarified.
The safety information records serious and other adverse-event counts for named groups, as well as a list of serious-event terms. It does not provide a controlled estimate of comparative safety, exposure-adjusted analyses or uncertainty intervals. The listed percentages cannot be assigned to individual groups in the registry record. As a result, the safety counts are descriptive rather than evidence on their own of a treatment effect.
More broadly, absence of a numerical result in the registry entries is not proof of no effect, and it is not proof that analyses were never conducted. It means that the effect and its uncertainty cannot be evaluated from the information recorded. The record also does not report why the study was terminated or whether termination influenced availability of analyses.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the difference between a design description and an interpretable result. Randomization, double masking and a placebo comparator describe ways the study sought to make a fair comparison. They do not substitute for the estimated treatment contrast, its uncertainty or a transparent account of the analysis. Those result elements are not reported in the registry record for the primary endpoint.
The endpoint is a continuous symptom-severity score, with an explicit scale range and a defined full-analysis-set population. Those details matter because they identify what was measured and who was intended to contribute to the analysis. At the same time, the registry's definition of evaluable data at each timeframe signals that the analyzed number may depend on outcome availability. Counts by group and the approach to missing data are not reported in the registry record, limiting assessment of the data underlying the endpoint.
The record also illustrates the interpretive difficulty of multiple outcome measures and time points. MADRS is accompanied by measures of depressive symptoms, global impression, irritability and disability. Without a reported multiplicity plan or a single primary comparison, it is not possible to determine how the trial prioritized findings or controlled interpretation across analyses. A list of outcomes alone cannot establish which comparisons were confirmatory.
Finally, the safety data distinguish serious events from other adverse events and give group-specific counts, while the serious-event term percentages lack group attribution in the registry entries. This distinction helps prevent descriptive counts from being mistaken for a comparative analysis. Taken together, the record gives a useful outline of the trial's question and measurement approach, but the missing statistical results and analysis details sharply limit what can be concluded about comparative effects.
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.
Several limitations specific to this record constrain interpretation. The primary outcome is specified as Week 14, while its timeframe describes Week 8 as double-blind baseline and Week 14 as week 6 of the double-blind phase. The record does not clarify this timing description. It also does not report the convention used to calculate change, which would be needed to interpret the sign of a change estimate.
No numerical primary comparison is available in the registry record. The record identifies the endpoint but gives no group means, contrast, confidence interval or p-value. It states that the primary outcome has several categories or time points and is not reduced to one comparison. Therefore, the size and precision of the primary result cannot be assessed.
The full analysis set is defined, but the primary outcome's analyzed number by group is not reported in the registry record. Missing-data amounts, reasons and methods are also not reported. Although the record includes multiple secondary outcomes and assessment weeks, it does not report a multiplicity strategy, a statistical model, or details of any sensitivity analyses. The sample-size justification for the trial is not reported; the separate planning assumptions are not a substitute for the trial's own design rationale.
The study is listed as terminated, but its reason and timing are not reported in the registry record. The relationship between the Open-Label ADT adverse-event group and the randomized groups is not explained in the registry record. Serious-event term percentages are listed without group attribution, deaths are recorded as null, and no comparative safety analysis is reported. These specific gaps prevent firm interpretation of both efficacy and safety from the available registry information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression — NCT01098240.
- Registry record last updated 2021-05-03; status last verified 2021-04.
- Results first posted 2013-06-26.
- 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
The registry record describes a randomized, double-blind, parallel, placebo-controlled phase 2a study of CP-601,927 augmentation of antidepressant therapy in major depressive disorder. Enrollment is listed as 297; the recorded start date is 2010-06-14, primary completion date is 2011-09-12, and status is terminated.
The primary endpoint is change in MADRS total score at Week 14, with a full analysis set defined by consumption of at least one dose of randomized study medication. The record does not provide a single numerical primary comparison, and it does not report the reason for termination, the primary endpoint's analyzed counts by group, missing-data methods, or the multiplicity strategy. Adverse-event counts and serious-event terms are recorded, but the registry entries available do not provide a comparative safety analysis or group attribution for the listed serious-event percentages. Thus, the record describes the study question and selected methods but does not permit quantification of the primary result.