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 Depression-Diabetes Mechanisms: Urban African Americans (NCT00209170), a randomized phase 4 study. The primary outcome is Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00209170 |
| Phase | Phase 4 |
| Condition | Diabetes, Depression |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Emory University |
| Results posted | Yes |
2. Clinical Question
Population
Participants with type 2 diabetes and depression were the focus of the study. The registry describes an urban African American population and lists diabetes and depression as the conditions. Enrollment was 20.
Intervention
The intervention was Beating the Blues, described as computerized cognitive behavioral therapy, paired with escitalopram. The record describes escitalopram as 10 mg taken orally once or twice daily for 6 months.
Comparator
The comparison group received the same computerized cognitive behavioral therapy paired with placebo, taken orally one to two tablets daily for 6 months. The registry does not describe a group receiving either component alone.
Primary question
The primary endpoint classified participants by change in the 21-item Hamilton Depression Rating Scale from baseline to week 24. The registry record does not report how many participants in either group met each response category.
The study rationale connects depression with both diabetes management and biological processes. The registry summary describes possible links through neurohormonal activation, inflammatory mediators, insulin resistance, and adherence to diet plans, medication, and scheduled appointments. It also states that the relationship between treating depression and changes in these processes, adherence, and glycemic control was not known.
The direct comparison was between two treatment combinations: cognitive behavioral therapy plus escitalopram and cognitive behavioral therapy plus placebo. Accordingly, the primary question concerns depression-response categories for these combinations, rather than the separate contribution of cognitive behavioral therapy or medication. The record identifies a response endpoint but does not report results for it, nor does it report an estimate comparing the groups.
3. Trial Design
This was a randomized, parallel-group phase 4 trial sponsored by Emory University. The registry lists quadruple masking, but does not specify which participant or study roles were masked. It records enrollment of 20 and describes two treatment groups: Beating the Blues computerized cognitive behavioral therapy with escitalopram, and the same therapy with placebo.
The registry describes the escitalopram regimen as 10 mg taken orally once or twice daily for 6 months. The placebo regimen is described as one to two tablets by mouth daily for 6 months. These are descriptions of the assigned regimens in the record; the record does not report adherence to treatment or the number of participants who completed the planned treatment.
The study start is listed as 2004-05, and primary completion as 2008-05. Its status is completed. The registry does not report the number assigned to each group, the number analyzed for the primary endpoint, or participant flow from enrollment through follow-up. The enrollment figure therefore should not be treated as the group size for either arm.
In general, random allocation is intended to make treatment groups comparable at the start of a study, while masking can reduce the influence of knowledge of assignment on participant experience, care, or outcome assessment. The record identifies random allocation and quadruple masking but does not provide enough detail to describe how allocation was generated or concealed, or which people were masked. It also does not report a protocol-level statistical analysis plan, sample-size justification, or planned interim analyses. These design details should not be inferred from the trial’s phase, masking label, or enrollment.
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: The study consented 20 subjects, but 6 subjects were not randomized into treatment groups because they were lost to follow-up.
Overall Study
| Stage | Beating the Blues CBT + Escitalopram | Beating the Blues CBT + Placebo |
|---|---|---|
| STARTED | 7 | 7 |
| COMPLETED | 5 | 4 |
| NOT COMPLETED | 2 | 3 |
Reasons for not completing this period:
| Reason | Beating the Blues CBT + Escitalopram | Beating the Blues CBT + Placebo |
|---|---|---|
| Adverse Event | 0 | 1 |
| Withdrawal by Subject | 2 | 1 |
| Lack of Efficacy | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Last Observation Carried Forward
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 | Beating the Blues CBT + Escitalopram | Beating the Blues CBT + Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 7 | 7 | 14 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 7 | 7 | 14 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 7 | 5 | 12 |
| Sex: Female, Male: Male | Participants | 0 | 2 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24, measured over Baseline, week 24.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants classified by response on the 21-item Hamilton Depression Rating Scale (HDRS), comparing the baseline score with the score at week 24. The registry describes the HDRS as a depression-severity measure. Its items are rated from 0, for symptoms not present, to a maximum of 2 to 4, for symptoms that are extremely severe; the total score ranges from 0 to 60, with higher scores indicating greater severity.
The record defines no response as a change of less than 25%, partial response as a change described as less than or equal to 50% to greater than 25%, and response as a change of 50% or greater. The wording places 50% within both the partial-response and response descriptions, so the category boundary is not unambiguous in the registry record. The record does not explain how that wording was resolved in the analysis.
A categorical response endpoint can communicate how many participants reached specified levels of change, rather than only describing an average score change. It also depends on the chosen thresholds: participants with similar score changes can be placed in different categories when they fall on opposite sides of a threshold. The registry specifies last observation carried forward as the population or missing-data approach associated with this outcome, but does not report the category counts or an effect estimate comparing groups. Thus, the endpoint definition is available, while the primary outcome results are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the primary outcome but does not report the number of participants in each response category, a comparison between treatment groups, or an estimate of uncertainty for that comparison. It is therefore not possible to determine from the posted results how the groups differed on the defined depression-response endpoint. The record’s completed status does not itself establish what the results were.
The outcome is categorical: each participant is assigned to a response category using change in HDRS from baseline to week 24. For a categorical endpoint, results would ordinarily be presented as counts in each category, often alongside the number assessed in each group. A group comparison could then describe the difference in response distributions or focus on a prespecified category contrast. The registry record does not identify a single contrast among the listed categories. It notes that the primary outcome has several categories or time points and is not reduced to one comparison. No single inferential comparison should therefore be assumed.
The enrollment of 20 indicates a small study population in absolute terms, but the number analyzed for the primary endpoint and the group sizes are not reported. In general, estimates based on small groups can be imprecise, particularly for outcomes divided among several categories. That general concern cannot be quantified for this trial without the category counts and an uncertainty estimate. No confidence interval or p-value for the primary outcome is reported in the registry record.
The listed endpoint concerns depression response, not the broader proposed pathways in the study rationale. The registry summary discusses potential links among depression, biological mechanisms, adherence, and glycemic control, but does not report those as primary outcome results. It would be inappropriate to treat the stated rationale as evidence that any of those processes changed in this trial.
The study compares two combined regimens, each including computerized cognitive behavioral therapy. Any reported contrast between them would concern the addition of escitalopram rather than placebo alongside that therapy; it would not isolate the effect of the therapy itself against no therapy. However, the registry record does not report the primary outcome comparison, so even that treatment-combination contrast cannot be described from the posted results. The available information supports an account of the design and endpoint, not a conclusion about comparative depression response.
9. Statistical Methods Explained
The registry describes random allocation, quadruple masking, and a parallel-group model. In general, random allocation assigns participants to study groups by chance, with the aim of reducing systematic differences between groups at the start. Parallel-group designs follow distinct groups assigned to different regimens. Masking is intended to limit the effects of knowing treatment assignment, but the registry does not identify which roles were masked or describe the masking procedures. It also does not report the method used to generate the allocation sequence or conceal assignments.
What does the endpoint classify?
The HDRS outcome is reduced to response categories based on the change from baseline to week 24. A categorical endpoint records membership in a defined group rather than preserving every score change as a continuous value. In general, this can make results easier to interpret in terms of threshold-defined responses, but it discards information about the size of changes within each category. It also makes the category definitions important. The registry’s partial-response wording reaches to 50%, while the responder definition begins at 50% or greater; the record does not clarify how a change exactly at that boundary was assigned.
The HDRS is described as ranging from 0 to 60, with higher scores indicating greater depression severity. The registry describes its items as rated from 0 to a maximum of 2 to 4, depending on the item. A response is defined through percentage change, but the record does not give a detailed calculation rule for that percentage, nor does it report participant-level scores or category counts. The listed endpoint therefore cannot be independently reconstructed from the registry description.
What does a comparison of categorical outcomes involve?
In general, categorical outcomes are summarized by the number of participants in each category and the number assessed. A statistical comparison may evaluate whether the pattern of category membership differs between groups. The particular method depends on the analysis plan, the number of categories, the group sizes, and whether the categories are treated as ordered. The registry record does not report a selected statistical test, a prespecified category contrast, an adjusted model, or a primary-outcome estimate. It notes that the outcome has several categories or time points and is not reduced to one comparison. No specific test or inferential result should be attributed to the trial.
A confidence interval, in general, describes the range of effect estimates compatible with the observed data under the method’s assumptions. It communicates precision as well as direction and magnitude. A p-value, in general, measures how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the test assumptions held. Neither quantity replaces the treatment-effect estimate, and neither alone indicates clinical importance. The registry record does not report a confidence interval or p-value for the primary endpoint.
How should the missing-data approach be understood?
The registry identifies last observation carried forward for the primary outcome. In general, this approach substitutes a participant’s last recorded observation for a later value that is missing. It can allow some participants with incomplete follow-up to contribute to an analysis, but it assumes that carrying the earlier value forward is an appropriate representation of the missing later outcome. That assumption may not hold if the outcome changes after the last observation. The registry does not report how many observations were missing, when they were missing, or whether sensitivity analyses examined alternative assumptions.
Missing-data handling is distinct from defining the analysis population. The record’s phrase identifying last observation carried forward does not establish how many randomized participants were included in the primary analysis or whether all randomized participants were analyzed in their assigned groups. The analysis population and the details of exclusions are not reported in the registry record.
What can the design and enrollment tell us about precision?
In general, larger samples tend to provide more information about an outcome and can support more precise estimates, although precision also depends on the outcome distribution and analysis. Here, enrollment was 20, but group sizes, primary-outcome counts, and an effect estimate are not reported. Precision cannot be assessed numerically. A planning calculation is not an observed trial result, and the registry does not report its own sample-size justification or power assumptions. The sample size should not be interpreted as evidence that a particular effect was detectable or excluded.
Multiplicity refers, in general, to the risk of misleading findings when multiple outcomes, comparisons, time points, or analyses are considered. A statistical plan may specify a primary comparison or methods for accounting for multiple tests. The registry record does not report such a plan, an adjustment for multiplicity, or interim analyses. The presence of a categorical endpoint alone does not identify how multiplicity was handled. Without a documented plan and reported analysis, it is not possible to assess whether a particular analysis was prespecified.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies one primary outcome measure, but its definition includes multiple response categories. It also notes that the primary outcome has several categories or time points and is not reduced to one comparison. The record does not report a single prespecified contrast among the categories, a multiplicity adjustment, or a broader statistical analysis plan. It also does not report interim analyses. Thus, the handling of multiple possible comparisons cannot be assessed from the registry record.
Last observation carried forward is identified for the primary outcome. In general, this method carries a participant’s last recorded value forward when a later measurement is missing. Its validity depends on assumptions about what the unobserved value would have been. The record does not report the amount or pattern of missing outcome data, reasons for missingness, or sensitivity analyses using other assumptions. It also does not state how many participants contributed to the outcome analysis.
The analysis population is not described beyond the last-observation-carried-forward wording. The registry does not say whether the primary analysis included every randomized participant, only those with available follow-up, or another defined group. It does not report exclusions or departures from assigned treatment. These omissions limit assessment of attrition and of whether the analysis preserved the randomized comparison.
In general, a prespecified analysis plan helps distinguish planned analyses from choices made after results are known. The registry record does not report enough detail about the analysis plan to evaluate that distinction. The primary outcome response counts and a comparative estimate are also not reported, so the effects of missing data or multiple comparisons cannot be examined against the posted outcome results.
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 |
|---|---|---|---|
| Beating the Blues CBT + Escitalopram | 1 | 7 | 14.3% |
| Beating the Blues CBT + Placebo | 2 | 7 | 28.6% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Beating the Blues CBT + Escitalopram | 7 of 7 |
| Beating the Blues CBT + Placebo | 7 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | Beating the Blues CBT + Escitalopram | Beating the Blues CBT + Placebo |
|---|---|---|---|
| Suicide attempt using insulin | Psychiatric disorders | 0 of 7 | 1 of 7 |
| Exacerbation of asthma | Respiratory, thoracic and mediastinal disorders | 1 of 7 | 0 of 7 |
| Diabetic ketoacidosis | Endocrine disorders | 0 of 7 | 1 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Beating the Blues CBT + Escitalopram | Beating the Blues CBT + Placebo |
|---|---|---|---|
| Headache | Nervous system disorders | 3 of 7 | 5 of 7 |
| Dyspnea | Cardiac disorders | 2 of 7 | 3 of 7 |
| Joint Pain | Musculoskeletal and connective tissue disorders | 1 of 7 | 3 of 7 |
| Elevated blood pressure | Cardiac disorders | 2 of 7 | 2 of 7 |
| Insomnia | General disorders | 3 of 7 | 1 of 7 |
| Nausea | Gastrointestinal disorders | 1 of 7 | 3 of 7 |
| Chest tightness | Cardiac disorders | 2 of 7 | 1 of 7 |
| Orthostatic tachycardia | Cardiac disorders | 1 of 7 | 2 of 7 |
| Sweating | Skin and subcutaneous tissue disorders | 1 of 7 | 2 of 7 |
| Orthostatic hypotension | Cardiac disorders | 1 of 7 | 2 of 7 |
Serious events with the highest arm-level rate: suicide attempt using insulin (14.3%), exacerbation of asthma (14.3%), diabetic ketoacidosis (14.3%).
The registry lists 7 participants at risk for serious adverse events in each treatment group. It records 1 participant affected in the Beating the Blues CBT plus escitalopram group and 2 participants affected in the Beating the Blues CBT plus placebo group. These are counts within the registry’s serious-adverse-event reporting fields; they do not provide details about timing, duration, severity beyond the serious classification, or causal relationship to treatment.
The registry lists suicide attempt using insulin, exacerbation of asthma, and diabetic ketoacidosis among the serious adverse event terms, each with a reported value of 14.3%. The record does not map those terms to a treatment group or give enough information to determine whether terms refer to distinct participants or events. They should not be assigned to a group based on the group-level affected counts.
For other adverse events, the record lists 7 participants affected out of 7 at risk in each group. Deaths are not reported in the registry record. In general, adverse-event counts describe events observed and recorded under the study’s reporting procedures; they do not by themselves establish that a treatment caused an event. The small number of participants and the limited detail in the registry record do not support a broader safety comparison.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, parallel-group study compared computerized cognitive behavioral therapy paired with escitalopram against the same therapy paired with placebo. Its primary endpoint was participant response based on change in HDRS from baseline to week 24, with last observation carried forward identified for the outcome. Those details describe what the trial set out to compare and how the endpoint was framed.
The record does not report the response-category counts, a treatment-group estimate, a confidence interval, or a p-value. It therefore does not establish which group had more participants in any response category or how precise a group difference might be. The completed status is not a substitute for outcome reporting, and the treatment descriptions do not demonstrate an effect.
The trial’s rationale discusses depression in relation to diabetes management, adherence, glycemic control, and biological mechanisms. Those statements motivate the research question; they are not results from the primary endpoint. The registry record does not report results for changes in adherence, glycemic control, neurohormonal activation, inflammatory mediators, or insulin resistance. No conclusion about those outcomes can be drawn from the endpoint definition or safety entries.
Even if a comparison of the two assigned groups were available, it would concern the combined regimens used in this study. Because both groups received computerized cognitive behavioral therapy, such a comparison would not by itself estimate the effect of that therapy versus no therapy. The registry record also does not report enough analysis details to assess the primary analysis population, missing-data sensitivity, or multiplicity handling.
The defensible interpretation is limited: the study was designed to compare two treatment combinations on a defined depression-response outcome, but the primary comparative results are not reported in the registry record. This information describes the research question and the available reporting, not whether either regimen is effective or ineffective.
13. Why This Trial Matters Statistically
This trial illustrates why a clearly named outcome is not the same as a reported result. The registry specifies the HDRS measure, the baseline-to-week-24 comparison, response categories, and a missing-data approach. Yet without the number of participants in each category and a comparison between groups, readers cannot estimate the observed treatment contrast or its precision.
The endpoint also shows how categorization affects interpretation. In general, threshold-based categories can be straightforward to communicate, but they depend on cut points and can obscure differences among participants placed in the same category. Here, the registry’s wording for partial response reaches to 50%, while the responder category begins at 50% or greater. The unresolved boundary makes transparent reporting of the operational classification especially important.
The two groups share computerized cognitive behavioral therapy, so the design focuses on the comparison of escitalopram with placebo as an addition to that therapy. This distinction matters when describing what a between-group contrast could answer: it would not isolate the effect of cognitive behavioral therapy against no therapy. The record’s intervention descriptions allow that design feature to be identified, while its absent outcome results prevent a conclusion about the contrast itself.
The registry also records last observation carried forward but gives no information about missingness or sensitivity analyses. In general, a named method does not show whether its assumptions were appropriate for the observed missing-data pattern. Likewise, listing multiple response categories without a reported analysis plan leaves the handling of possible comparisons unclear. Together, these features make the distinction between endpoint definition, analysis specification, and result reporting central to interpreting this study.
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 primary limitation of the registry record for interpretation is that it defines the primary endpoint without reporting its category counts or comparative results. The number analyzed in each group, the effect estimate, and its precision are not reported. Enrollment was 20, but the record does not give group-specific enrollment or participant flow, so the available information does not establish how many participants contributed to the primary outcome.
The response-category wording has an unclear boundary: partial response is described as less than or equal to 50% to greater than 25%, while response begins at 50% or greater. The record does not explain assignment at that boundary or give the detailed calculation rule used for percentage change. This limits reproducibility of the stated endpoint definition.
Last observation carried forward is named, but the amount and pattern of missing data and any sensitivity analyses are not reported. The analysis population is also not described. A statistical analysis plan, sample-size justification, interim analyses, and multiplicity procedures are not reported in the registry record. The record does not specify the roles covered by quadruple masking or details of allocation generation and concealment.
The safety entries give group counts and listed serious-event terms but limited context, including no group assignment for the listed terms. These registry-level limitations do not establish that the study lacked further methods or results elsewhere; they mean those details are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Depression-Diabetes Mechanisms: Urban African Americans — NCT00209170.
- Registry record last updated 2015-07-29; status last verified 2015-07.
- Results first posted 2015-07-29.
- 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
NCT00209170, titled Depression-Diabetes Mechanisms: Urban African Americans, is listed as a completed, randomized, quadruple-masked, parallel-group phase 4 trial sponsored by Emory University. Enrollment was 20. The registry lists diabetes and depression as conditions and describes two groups receiving computerized cognitive behavioral therapy paired with escitalopram or placebo.
The primary outcome was participant response on the 21-item HDRS from baseline to week 24, with last observation carried forward identified. The registry record does not report the primary response counts or a comparative estimate. It lists serious adverse events affecting 1 participant in the escitalopram group and 2 in the placebo group, with 7 at risk in each group. The registry does not report deaths.
The study start is listed as 2004-05 and primary completion as 2008-05. The analysis population, detailed statistical plan, sample-size justification, and handling of multiple comparisons are not reported in the registry record.