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 Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression (NCT00602355), a randomized phase 2 study. The primary outcome is Hamilton Depression Rating Scale (HAM-D).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00602355 |
| Phase | Phase 2 |
| Condition | Depression, Postpartum |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 162 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Women and Infants Hospital of Rhode Island |
| Results posted | Yes |
2. Clinical Question
Population
Women with postpartum depression. The registry record lists postpartum depression as the condition; further eligibility details and the analyzed population are not reported in the registry record.
Intervention
Sertraline with clinical management plus mothercrafting, or interpersonal psychotherapy (IPT) alone.
Comparator
Placebo pill with clinical management plus mothercrafting. The record also lists the sertraline arm, IPT arm, and placebo arm as the three study groups.
Primary question
How did Hamilton Depression Rating Scale (HAM-D) scores change or compare across the treatment groups at baseline, post-treatment, and Months 3 and 6 of follow-up?
The listed primary measure is a continuous depression-severity score, with lower scores indicating better outcomes. However, the registry record does not give group means, standard deviations, between-group estimates, confidence intervals, or tests for the primary measure. It therefore does not establish from the posted results how the groups compared at any of the specified assessments.
The arm descriptions distinguish a medication comparison in which the accompanying clinical management and mothercrafting are common to both arms from an IPT-alone arm. This means that the treatment packages differ in more than one way when IPT is compared with either medication arm: the IPT arm is described as alone, whereas both medication arms include the listed behavioral components. The registry record does not describe a factorial allocation or provide a direct statistical contrast that separates the effects of each component.
The record lists secondary measures of depression illness severity, global illness severity, social functioning, and anxiety. Their presence indicates that the study planned or registered broader outcome measurement, but their results and analysis details are not reported in the registry record. A clinical question can be identified from the study descriptions; an answer about comparative outcomes cannot be recovered from the posted results alone.
3. Trial Design
The registry identifies this study as a randomized, parallel-group, phase 2 trial with quadruple masking. It is marked completed. The study start is recorded as 2008-02, and primary completion as 2014-07. Enrollment is listed as 162. These record entries describe the registered study; they do not supply information about how many participants contributed data to any particular outcome or analysis.
Three arms are described. The placebo group received a placebo pill with clinical management plus mothercrafting. The sertraline group received active sertraline with the same listed clinical management and mothercrafting. The IPT group received interpersonal psychotherapy alone. Although the record classifies allocation as randomized, the allocation ratio, sequence-generation procedure, concealment procedure, and practical details of masking are not reported in the registry record. The meaning of quadruple masking for specific roles is also not reported.
The primary outcome is HAM-D, assessed at baseline, post-treatment, and Months 3 and 6 of follow-up. The registry describes a score ranging from 0 to 50, with lower values indicating better outcomes. The listed secondary outcomes are the Beck Depression Inventory, Clinical Global Impression scale, Postpartum Adjustment Questionnaire, and Hamilton Anxiety Rating Scale. The registry also lists sertraline, placebo, IPT, clinical management, and mothercrafting among the interventions.
The record contains no primary-outcome analysis in the posted results: it notes that the outcome has several categories or time points and was not reduced to one comparison. The statistical analysis plan, sample-size justification, planned contrasts, handling of repeated measurements, and analysis populations are not reported in the registry record. Thus, the design features identify the broad randomized comparison, but do not determine which statistical model or estimand should be used to interpret it.
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 | 1 (Placebo) | 2 (Sertraline) | 3 (IPT) |
|---|---|---|---|
| STARTED | 53 | 56 | 53 |
| COMPLETED | 44 | 38 | 43 |
| NOT COMPLETED | 9 | 18 | 10 |
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 | 1 (Placebo) | 2 (Sertraline) | 3 (IPT) | Total |
|---|---|---|---|---|---|
| Participants analysed | 53 | 56 | 53 | 162 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 53 | 56 | 53 | 162 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 |
| Age, Continuous | years | 27.28 (SD 5.11) | 28.16 (SD 5.63) | 26.26 (SD 6.15) | 27.25 (SD 5.67) |
| Sex: Female, Male: Female | Participants | 53 | 56 | 53 | 162 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 17 | 14 | 13 | 44 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 36 | 41 | 40 | 117 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 0 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 7 | 7 | 10 | 24 |
| Race (NIH/OMB): White | Participants | 31 | 36 | 32 | 99 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 14 | 13 | 10 | 37 |
| Region of Enrollment: United States | participants | 53 | 56 | 53 | 162 |
6. Primary Endpoint
The registry lists the primary outcome as Hamilton Depression Rating Scale (HAM-D), measured over Measured at baseline; post-treatment; and Months 3 and 6 of follow-up.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Hamilton Depression Rating Scale (HAM-D), a measure of depression severity. The registry reports that its total score ranges from 0 to 50 and that lower scores indicate better outcomes. The measure is recorded at baseline, post-treatment, and Months 3 and 6 of follow-up. The registry describes the endpoint as a mean of a continuous measure, with standard deviation as the dispersion measure.
As a general statistical concept, a continuous scale can represent variation in symptom severity across participants rather than reducing results to a yes-or-no classification. A group mean describes the average recorded score, while a standard deviation describes how spread out individual scores are around that mean. Both can help characterize an outcome, but neither alone establishes whether a difference between groups is precisely estimated or attributable to a particular treatment.
Repeated assessments can describe outcomes at different stages, including after treatment and during follow-up. The baseline assessment may also help characterize starting severity, but the registry record does not report how baseline scores were used in the analysis. Nor does it report a single primary contrast, an analysis of change from baseline, or a model accounting for repeated observations. The endpoint is relevant to the stated question because it measures depression severity, but its results cannot be interpreted comparatively without the group-level estimates and their uncertainty.
The registry record gives the scale range and direction but does not report a threshold for meaningful change, a responder definition, or an interpretation rule for differences in score. Those details should not be inferred from the scale description. No HAM-D results are reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies a randomized comparison of three treatment groups and names HAM-D as the primary outcome. It does not post the HAM-D means, standard deviations, estimated group contrasts, confidence intervals, or test results. In consequence, the comparative primary-outcome result is not reported in the registry record. The design description alone cannot establish which group had lower scores, how large any difference was, or how precisely it was estimated.
The outcome was measured at baseline, post-treatment, and Months 3 and 6 of follow-up. These are distinct assessment occasions, not a single result. A contrast at post-treatment would address a different time point from a contrast during follow-up; results could also depend on whether the analysis compares endpoint scores, changes from baseline, or trajectories across assessments. The record does not specify or report such contrasts. Its note that the primary outcome has several categories or time points and was not reduced to one comparison confirms that a single primary comparison is not posted.
In general, an estimate describes the direction and magnitude of a contrast, while a confidence interval describes the range of values compatible with the data and the analysis assumptions. A p-value, if reported, would address compatibility with a specified null hypothesis under a statistical model; it would not by itself show clinical importance or prove that a treatment caused an outcome. None of these inferential results for HAM-D is reported in the registry record, so no conclusion about statistical significance or precision can be drawn.
The registry lists four secondary outcome measures: BDI, CGI, PPAQ, and HARS. It does not report their numerical results or explain which comparisons were performed. The record lists five outcome measures overall, but does not provide results for all of them. The entry of zero analyses does not establish that no analyses were conducted; it means that analyses are not posted in the registry record.
The adverse-event information is separate from the primary efficacy outcome. The listed affected-participant counts and the serious-event terms can describe reported safety information, but they do not substitute for HAM-D results. Event timing, severity grading beyond the serious classification, relationship to study intervention, and statistical comparisons are not reported in the registry record.
Overall, the record supports a description of the randomized design, arms, primary measure, assessment schedule, and some adverse-event counts. It does not support a quantitative conclusion about comparative depression outcomes. Missing numerical results should not be interpreted as evidence of no difference, equivalence, or lack of effect.
9. Statistical Methods Explained
The registry describes allocation as randomized and the study as parallel-group. In general, random allocation is intended to reduce systematic differences in participant characteristics between groups at assignment. It does not guarantee that groups will be identical, and it does not by itself reveal how allocation was generated or concealed. Those procedures, along with the allocation ratio, are not reported in the registry record. The parallel-group description indicates that the listed arms are compared as groups; details of participant flow and follow-up are not given.
What does the continuous outcome description mean?
HAM-D is recorded as a continuous score, summarized in the registry as a mean with standard deviation. In general, the mean describes the center of the observed scores, while the standard deviation describes their variability. A mean difference can be useful for comparing groups on the same scale, but an estimate needs uncertainty information to show how precise it is. No group means, standard deviations, mean differences, or confidence intervals for HAM-D are reported in the registry record.
The registry gives a score range of 0 to 50 and states that lower scores indicate better outcomes. The score direction helps interpret a reported estimate, but it cannot supply an estimate that is absent. The registry record does not state a minimum important difference, a responder threshold, or another rule for deciding whether a given score contrast is clinically important.
How should repeated assessments be understood?
The primary measure was scheduled at baseline, post-treatment, and Months 3 and 6 of follow-up. Repeated measurements raise choices about the target comparison. An analysis might compare groups at a specified visit, compare change from baseline, or model the pattern over time. As a general concept, a repeated-measures model can account for the correlation between observations from the same participant; separate analyses at each visit may instead produce several estimates. The registry does not report which approach was used, whether baseline was included as a covariate, or how within-participant correlation was handled.
Since multiple visits are named and no single comparison is posted, the absence of an outcome result is especially important. A single statement about treatment-group differences would require a defined time point or an explicitly defined summary across visits. No such estimate is reported in the registry record. The record also does not specify whether the primary question concerned the arms separately, a combined contrast, or a particular pairwise comparison.
What do uncertainty and significance measures tell readers?
As a general statistical explanation, a confidence interval communicates uncertainty around an estimated quantity under a model and its assumptions. A narrower interval usually indicates greater precision than a wider one, but whether the interval includes a null value is not a complete judgment of practical importance. A p-value summarizes how compatible observed data are with a specified null hypothesis under a statistical model. It is not the probability that the null hypothesis is true, and it does not show the size or importance of an effect.
No HAM-D confidence interval, p-value, or other inferential statistic is reported in the registry record. Consequently, there is no basis for assessing the precision or statistical significance of the primary comparison from the posted results. The registry record also does not report the statistical model, covariates, assumptions, or procedures used to address departures from those assumptions.
What does the planning information mean?
The registry describes a sample-size planning illustration based on the observed effect. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed evidence about treatment effects and not observed power. The record does not report a trial-specific sample-size justification or explain how the registered illustration relates to the three-arm design. No planning values are stated in the registry record considered for this interpretation, so no participant requirement can be inferred.
As a general concept, power is a design-stage probability tied to a specified effect, variability, sample size, and testing procedure. It does not describe the probability that a result is true, and a post hoc calculation based on an observed effect should not be treated as proof that the study could or could not detect a meaningful difference. The registry does not report a protocol-based effect assumption, variance assumption, or planned power target.
What can be inferred from the posted analyses?
The record lists five outcome measures and zero analyses. This means no analysis results are posted in the registry record; it does not establish that researchers performed no analyses. The primary outcome is explicitly not reduced to one comparison because it has several categories or time points. The registry does not report the analysis population, missing-data method, treatment of protocol deviations, multiplicity procedure, or whether analyses were adjusted. These omissions prevent reconstruction of the intended statistical analysis and limit interpretation to the design and descriptive safety figures that are posted.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists HAM-D as the primary measure and four secondary measures: BDI, CGI, PPAQ, and HARS. HAM-D has assessments at baseline, post-treatment, and Months 3 and 6 of follow-up. Multiple measures and visits can create multiple opportunities to test or emphasize contrasts. As a general statistical issue, multiplicity procedures can help control the chance of false-positive findings across a defined family of tests. The registry record does not report a testing hierarchy, multiplicity adjustment, prespecified primary contrast, or strategy for interpreting secondary outcomes.
The primary outcome is not reduced to one comparison in the record because it has several categories or time points. This makes the missing analysis plan consequential: the record does not say which time point or summary was intended to carry the primary inference. No primary or secondary numerical results, confidence intervals, or test statistics are reported.
Missing-data handling is not reported in the registry record. The entry for enrollment does not establish how many participants had an observed HAM-D value at each assessment. The record does not report reasons for missing observations, follow-up completion, imputation, or whether analyses included all randomized participants or a subset. General methods for incomplete repeated measurements depend on assumptions about why data are missing; without a stated method and its assumptions, robustness cannot be assessed.
The analysis population is also not reported in the registry record. There is no description of an intention-to-treat, per-protocol, or safety population, nor a participant-flow account linking assignment to outcome availability. The absence of these details does not prove that such procedures were not used; it means they cannot be evaluated from the posted record.
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 |
|---|---|---|---|
| 1 (Placebo) | 7 | 53 | 13.2% |
| 2 (Sertraline) | 8 | 56 | 14.3% |
| 3 (IPT) | 8 | 53 | 15.1% |
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 |
|---|---|
| 1 (Placebo) | 20 of 53 |
| 2 (Sertraline) | 19 of 56 |
| 3 (IPT) | 16 of 53 |
Most frequent serious adverse event terms
| Event term | Organ system | 1 (Placebo) | 2 (Sertraline) | 3 (IPT) |
|---|---|---|---|---|
| Suicidal ideations or thoughts of self-harm | Psychiatric disorders | 1 of 53 | 2 of 56 | 0 of 53 |
| Infant hospitalized - bronchitis | Respiratory, thoracic and mediastinal disorders | 1 of 53 | 1 of 56 | 0 of 53 |
| Infant hospitalized - bronchiolitis | Respiratory, thoracic and mediastinal disorders | 0 of 53 | 0 of 56 | 2 of 53 |
| Participant hospitalized - gall bladder removal | Surgical and medical procedures | 0 of 53 | 2 of 56 | 0 of 53 |
| Attempted suicide | Psychiatric disorders | 0 of 53 | 1 of 56 | 0 of 53 |
| Participant hospitalized - kidney infection | Infections and infestations | 0 of 53 | 0 of 56 | 1 of 53 |
| Participant hospitalized - bronchitis | Respiratory, thoracic and mediastinal disorders | 0 of 53 | 0 of 56 | 1 of 53 |
| Worsening of neurovegetative symptoms | Psychiatric disorders | 1 of 53 | 0 of 56 | 0 of 53 |
| Infant hospitalized - dehydration, fever, vomiting (viral infection) | Infections and infestations | 0 of 53 | 1 of 56 | 0 of 53 |
| Participant hospitalized - hernia surgery | Surgical and medical procedures | 0 of 53 | 0 of 56 | 1 of 53 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 1 (Placebo) | 2 (Sertraline) | 3 (IPT) |
|---|---|---|---|---|
| Participant reported experiencing headaches | General disorders | 7 of 53 | 4 of 56 | 3 of 53 |
| Worsening of symptoms | Psychiatric disorders | 5 of 53 | 3 of 56 | 4 of 53 |
| Participant reported experiencing insomnia | General disorders | 2 of 53 | 5 of 56 | 3 of 53 |
| Participant reported experiencing decreased libido | General disorders | 7 of 53 | 2 of 56 | 0 of 53 |
| Patient reported experiencing severe fatigue/sleepiness | General disorders | 3 of 53 | 3 of 56 | 2 of 53 |
| Participant reported experiencing severe agitation | General disorders | 2 of 53 | 1 of 56 | 3 of 53 |
| Participant reported increased conflict with spouse or partner | Social circumstances | 1 of 53 | 0 of 56 | 1 of 53 |
| Patient reported experiencing delayed orgasm | Reproductive system and breast disorders | 1 of 53 | 1 of 56 | 0 of 53 |
| Participant reported experiencing dizziness/vertigo | General disorders | 0 of 53 | 2 of 56 | 0 of 53 |
| Participant experienced rash | Skin and subcutaneous tissue disorders | 2 of 53 | 0 of 56 | 0 of 53 |
Serious events with the highest arm-level rate: infant hospitalized - bronchiolitis (3.8%), suicidal ideations or thoughts of self-harm (3.6%), participant hospitalized - gall bladder removal (3.6%), infant hospitalized - bronchitis (1.9%), participant hospitalized - kidney infection (1.9%).
The registry lists affected-participant counts for serious adverse events and other adverse events in each group. For serious adverse events, it reports 7 affected among 53 at risk in the placebo group, 8 among 56 at risk in the sertraline group, and 8 among 53 at risk in the IPT group. For other adverse events, the corresponding entries are 20 among 53, 19 among 56, and 16 among 53. These are group-specific posted counts; no comparative statistical analysis is reported in the registry record.
The listed serious-event terms include infant hospitalized for bronchiolitis (3.8%), suicidal ideations or thoughts of self-harm (3.6%), participant hospitalized for gall bladder removal (3.6%), infant hospitalized for bronchitis (1.9%), participant hospitalized for kidney infection (1.9%), and participant hospitalized for bronchitis (1.9%). The record does not identify the group associated with each listed term, nor does it provide event counts or definitions for each term. The percentages should therefore be read as reported, without assigning them to a particular arm or inferring their denominator.
Death counts are not reported in the registry record. Event timing, seriousness criteria, intervention relationship, and details about whether participants could experience more than one event are also not reported. These descriptive entries do not establish a causal comparison or replace the missing primary-outcome results.
12. What the Result Does, and Does Not, Mean
The registry record describes a completed randomized phase 2 trial with three treatment arms and a repeated-measures primary outcome. It identifies the treatment packages and the HAM-D scale, including its range, direction, and assessment schedule. It also posts group-specific affected-participant counts for serious and other adverse events and a list of serious-event terms with percentages. These registry entries make the broad study question and some safety information clear.
What the record does not show is the comparative HAM-D result. There are no posted group means, standard deviations, contrasts, confidence intervals, or p-values for the primary measure. Without those quantities, it is not possible to describe the direction, magnitude, or precision of any difference between placebo, sertraline, and IPT. The missing result cannot be interpreted as no difference, as equivalence, or as evidence that an intervention did or did not improve depression severity.
The design also does not make every contrast a comparison of one isolated component. The placebo and sertraline arms include clinical management plus mothercrafting, while the IPT arm is described as IPT alone. Therefore, a contrast between IPT and a medication arm would compare the listed treatment packages; the record does not report an analysis that separates their individual components.
As a general principle, statistical significance and clinical importance are different questions. Even when an estimate and uncertainty interval are available, a reader needs the scale context and a justified criterion for meaningful change to assess practical relevance. The registry provides the score direction and range, but no meaningful-change threshold or numerical outcome estimate.
In short, the posted record supports a description of trial structure and reported adverse-event counts, but not a conclusion about comparative depression outcomes. The secondary measures are named without results, and the analysis methods and missing-data procedures are not reported. Interpretation should remain limited to what the registry actually records.
13. Why This Trial Matters Statistically
This trial is statistically notable for the combination of three randomized treatment groups and a continuous primary measure assessed at multiple times. Such a design requires a clearly defined comparison: the target may be a group contrast at a particular visit, a change from baseline, or a trajectory over follow-up. Those questions are related but not interchangeable. The registry lists the assessments but does not report a single primary comparison or its estimate.
The arm descriptions also matter for interpretation. Sertraline is paired with clinical management and mothercrafting, as is placebo, whereas IPT is described as alone. A medication-versus-placebo contrast is therefore framed within the same listed behavioral support, while a comparison involving IPT differs in the full treatment package. Recognizing the packages prevents a reader from attributing a hypothetical contrast to one component without supporting analysis.
For clinical research, a measure can be appropriate and still be insufficiently reported for statistical interpretation. HAM-D has a stated range and direction, but readers also need group summaries, an explicit estimand, uncertainty intervals, and an account of missing observations. The registry record does not report those elements. This makes the distinction between a registered design and posted results particularly important.
The record also illustrates why multiple outcomes and visits require transparent reporting. HAM-D and four secondary measures are listed, but no analysis results or multiplicity approach are posted. Without a prespecified hierarchy or analysis plan, readers cannot identify which result was intended to provide the principal inferential claim. The statistical importance of this trial in the registry record is therefore chiefly methodological: it shows the questions that a three-arm, longitudinal design raises, while leaving the outcome comparisons unavailable.
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 central limitation is that the registry record does not report numerical results for the primary HAM-D outcome, despite listing the measure and its assessment schedule. The absence of means, standard deviations, contrasts, and uncertainty measures prevents evaluation of the direction, size, and precision of the primary comparison. The record also does not report results for the listed secondary measures.
The primary measure has multiple assessment occasions, but no single comparison is posted. The analysis plan is not reported, including whether the intended target was a visit-specific difference, change from baseline, or a pattern across follow-up. The record does not describe the model, covariate adjustment, treatment of repeated measurements, or the handling of multiplicity.
Participant flow and outcome availability are not reported in the registry record. Enrollment is listed, but the number contributing to each outcome at each visit, reasons for missing observations, and analysis populations are not stated. Missing-data procedures and sensitivity analyses are not reported. The registered allocation description does not provide the sequence-generation or concealment methods, allocation ratio, or roles covered by quadruple masking.
The treatment arms also differ in their described components: the sertraline and placebo groups include clinical management plus mothercrafting, while IPT is described as alone. The record does not specify a component-separating analysis. Safety reporting is limited to group-level affected-participant counts and listed serious-event terms; event timing, group attribution for the terms, definitions, and statistical comparisons are not reported. These limits restrict interpretation to the design description and the posted safety entries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression — NCT00602355.
- Registry record last updated 2016-09-21; status last verified 2016-07.
- Results first posted 2016-09-21.
- 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
The registry identifies NCT00602355 as a completed randomized, parallel-group, phase 2 study with quadruple masking. It lists enrollment of 162, a study start of 2008-02, and primary completion of 2014-07. The trial compared placebo with clinical management plus mothercrafting, sertraline with the same listed supports, and IPT alone.
HAM-D is the primary outcome, measured at baseline, post-treatment, and Months 3 and 6 of follow-up. The scale is described as ranging from 0 to 50, with lower scores indicating better outcomes. The record also lists BDI, CGI, PPAQ, and HARS as secondary outcomes. It does not report primary or secondary outcome estimates or analyses.
Group-specific counts are posted for participants affected by serious and other adverse events, along with serious-event terms and percentages. Death counts and further event details are not reported in the registry record. The statistical analysis plan, missing-data approach, and analysis populations are also not reported.