Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility (NCT00953862), a na na study. The primary outcome is Change in Adult ADHD Investigator Symptom Rating Scale Score.

2. Clinical Question

3. Trial Design

This completed study enrolled 18 participants and is described as a 10-week, 2-phase, open-label trial in a residential treatment facility. The registry lists the study model as single-group, allocation as NA, and masking as none. The phase field is also listed as NA. The record does not explain what the two phases involved, so their operational definitions should not be inferred.

The intervention was atomoxetine. The treatment description says patients identified as having adult ADHD on the ACDS were offered an open-label trial, with a dose up to 120 mg/day over 10 weeks. Titration took place over four weeks and was based on clinical response and observed side-effects. The description of treatment is incomplete in the registry record, so no additional dosing or follow-up details can be established from it.

The primary endpoint was assessed at baseline and week 10. Its stated analysis population consisted of participants treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment. This is an endpoint-specific population description; the number of participants meeting it is not reported in the registry record. The overall enrollment of 18 should not be assumed to be the endpoint denominator.

The study also listed change in the Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score and change in the Clinical Global Impression—Severity of Illness Score as secondary outcomes. No outcome estimates or statistical analyses are reported in the registry record. Consequently, the design and outcome definitions can be described, but the treatment-associated changes and their precision cannot be evaluated.

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: Patients were excluded if they had a diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder, as assessed by clinical history and the SCID-I/P; seizure history (other than febrile seizures); current chronic or acute illness or medical condition, glaucoma, organic brain disease, traumatic brain injury, pregnancy, or lactation.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment

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.

Population: This number is the total number who were found eligible for the treatment.

6. Primary Endpoint

The registry lists the primary outcome as Change in Adult ADHD Investigator Symptom Rating Scale Score, measured over Baseline and week 10 of treatment.

The primary endpoint was change in the Adult ADHD Investigator Symptom Rating Scale (AISRS) score from baseline to week 10 of treatment. The AISRS is described as an 18-item measure whose items correspond directly to the 18 DSM-IV symptoms of ADHD. Each item uses a 4-point scale, scored from 0 for none to 3 for severe. The summed total ranges from 0 to 54, and higher scores indicate more severe symptomatology.

A change score is intended to describe how a participant’s measured symptom severity differs between the start and a later assessment. The scale’s symptom-focused content makes it relevant to the stated objective of assessing ADHD symptoms during treatment. The direction of an individual change depends on the scoring convention: because higher scores represent more severe symptoms, a lower follow-up score would represent lower measured symptom severity. That general interpretation does not establish why any change occurred.

The endpoint’s timeframe was baseline and week 10. The registry record does not report the mean change, its standard deviation, or the number of participants included in the endpoint analysis. It therefore does not show the size or precision of the recorded change, or whether the result was statistically distinguishable from no change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes a continuous primary outcome summarized as a mean, with standard deviation as the measure of dispersion. General statistical context can help explain what those summaries would communicate if reported, but the primary estimate and its standard deviation are not reported in the registry record.

What does a mean change describe?

For a continuous measure, a mean change is the average of participant-level changes between the specified assessments. Here, the stated assessments are baseline and week 10, and the measure is AISRS score. A mean condenses the group’s changes into a single location summary. It does not show whether all participants changed similarly: a group mean can coexist with a range of individual responses. The registry record does not report individual-level results or the observed group mean change.

What does a standard deviation describe?

As a general statistical concept, the standard deviation describes how spread out individual observations or changes are around their mean. A smaller standard deviation indicates values more concentrated around the mean, while a larger one indicates greater spread. It is not the same as a confidence interval: a standard deviation describes variability in the observed data, whereas a confidence interval describes uncertainty around an estimated quantity under specified assumptions. Neither the primary endpoint’s standard deviation nor a confidence interval is reported in the registry record.

What would a confidence interval add?

In general, a confidence interval gives a range of values compatible with the data and the statistical procedure used, reflecting sampling uncertainty. Its width depends in part on the amount of information and the variability in the data. A narrow interval generally indicates greater precision than a wide interval, but an interval does not remove design limitations or establish causation. No confidence interval is reported for the primary endpoint, so the precision of the estimated change cannot be assessed.

Why does the study design matter?

The single-group, open-label design has no concurrent control arm. General statistical reasoning distinguishes a within-group change from a between-group contrast: the former describes change over time among participants in the group, while the latter compares outcomes under different assigned conditions. A single-group study cannot estimate a randomized contrast against a control group. Open-label treatment also means masking was absent, which can matter to outcome measurement and behavior in general. These considerations do not establish that bias occurred; they describe what the design can and cannot separate.

What does over-dispersion mean in general?

Over-dispersion refers generally to observed variability greater than a statistical model assumes. When that occurs, model-based standard errors may be too small if the extra variability is not accommodated, which can make confidence intervals too narrow and tests too optimistic. This concept is relevant to choosing models for some kinds of data, but the primary outcome is described as a continuous score summarized by a mean and standard deviation. No model specification or diagnostic assessment is reported in the registry record, and there is no basis to claim that over-dispersion was present.

How should the planning assumptions be read?

The listed planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They consider effects expressed as fractions of an observed effect. These assumptions describe hypothetical sample-size planning, not the study’s observed analysis: the study itself is recorded as single-group, and the observed effect is not reported in the registry record. Sample-size illustrations are not observed power and cannot show what this trial’s results established. The registry record does not report the trial’s own sample-size justification, and no protocol-based rationale should be inferred.

For general context, a significance level is a prespecified threshold used in a hypothesis-testing procedure to control the long-run rate of false-positive results under the test’s assumptions. A two-sided test considers departures in either direction. A p-value, if reported, would quantify how unusual the data or more extreme data would be under a specified null model; it would not measure the probability that the null hypothesis is true, nor the size or importance of an effect. No p-value or test result is reported in the registry record.

The registry record reports no statistical analyses. It also does not describe the model used for the primary outcome, the treatment of repeated measurements, or adjustments for covariates. Such methods should not be imputed from the outcome definition or the planning assumptions.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Atomoxetine Arm")
n   <- c(12)
m   <- c(17.3)
sp  <- c(11.9)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Atomoxetine Arm  12  17.300  11.900  9.739  24.861

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome, change in AISRS score, and two secondary outcomes: change in the Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score and change in the Clinical Global Impression—Severity of Illness Score. It does not report a multiplicity plan, such as a hierarchy of tests or an adjustment for considering several outcomes. The approach to multiplicity is therefore not reported in the registry record.

As a general statistical issue, evaluating multiple outcomes can increase the chance of finding at least one apparently notable result by chance if each is tested separately. Prespecified strategies can address that issue, but no strategy should be assumed. Since the registry record reports no outcome analyses or results, there is no basis to assess whether multiplicity affected any conclusion.

The primary endpoint population is described as participants treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment. The number of participants in this population is not reported in the registry record. Nor does the record state how missing endpoint measurements were handled, whether participants with incomplete data were excluded, or whether any imputation or sensitivity analysis was used. These details are important because analysis choices can affect an estimate when outcome data are incomplete.

The record does not report whether analyses followed an intention-to-treat approach or another analysis-population definition beyond the primary endpoint description. The recorded enrollment of 18 does not establish the denominator used for any outcome. Although three outcome measures are listed, the registry record reports 0 analyses; no statistical results or analysis population counts are available to clarify these points.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry record lists 18 participants at risk for serious adverse events and 0 with serious adverse events during the treatment phase. It also lists 18 participants at risk for other adverse events and 9 with other adverse events. These are counts recorded in the registry, not estimates of comparative risk: the study had no concurrent control group, and the adverse-event record does not support a randomized safety comparison.

The death count is not reported in the registry record. A blank or unavailable death value should not be read as a count of zero. No top serious adverse-event terms are listed, alongside the reported count of 0 participants with serious adverse events.

These figures describe the recorded safety categories for this study. They do not establish that every possible event was captured, indicate how events were distributed over time, or show whether events were considered related to atomoxetine. Such details are not reported in the registry record. The small overall enrollment also limits how much can be inferred about uncommon events; this is a general limitation of safety interpretation in a small study, not evidence that an unreported event occurred.

13. What the Result Does, and Does Not, Mean

The registry record establishes that a completed, 10-week, open-label, single-group trial assessed atomoxetine in adults with ADHD and substance use disorder in a residential treatment facility. It describes a primary symptom-score endpoint measured at baseline and week 10, as well as two secondary outcomes. It also records enrollment of 18 and reports safety counts for the treatment phase.

The record does not report the primary mean change, its standard deviation, or any statistical analysis. Therefore, it is not possible to state how much the AISRS score changed, how variable participant changes were, or how precise an estimate might be. The two secondary outcome results are also not reported in the registry record. No conclusion about statistical significance or consistency across outcomes can be drawn from the recorded results.

Even if a within-group change had been reported, a single-group study would describe change over time rather than a randomized comparison with an untreated or differently treated group. General influences associated with time, the residential setting, or measurement could not be separated from treatment effects by this design alone. The open-label setup further means treatment was not masked. These points limit causal interpretation; they do not prove that any particular influence affected the results.

The safety figures record 0 participants with serious adverse events among 18 at risk and 9 participants with other adverse events among 18 at risk. The death count is not reported in the registry record. These counts do not establish comparative safety, and the absence of a reported serious event count does not answer every safety question.

In short, the registry record describes what the trial set out to measure and reports limited safety counts, but it does not provide the efficacy estimates needed to quantify the primary or secondary outcomes. The findings should not be extended beyond the enrolled study population, setting, and design.

14. Why This Trial Matters Statistically

This trial is statistically notable because its stated clinical question concerns change in symptoms, but its registry record does not report the primary outcome estimate or an analysis result. That makes a distinction between outcome definition and outcome evidence especially important. A well-described endpoint tells readers what was intended to be measured; it does not, by itself, show what happened to the measured scores.

The single-group design also illustrates why before-and-after measurement is not the same as a controlled treatment comparison. A baseline-to-week-10 change could describe the participants’ course during treatment, but without a concurrent comparison group it would not isolate the contribution of atomoxetine from other influences over the same period. This is a general design limitation, rather than a claim that the observed course had any particular cause.

Outcome-population details matter too. The primary endpoint description excludes participants discontinued because they received less than 2 weeks of treatment, yet the endpoint denominator and missing-data approach are not reported in the registry record. Readers therefore cannot determine how many participants contributed to the primary estimate or how incomplete measurements were addressed.

The record also lists multiple outcomes without reporting a multiplicity plan or outcome analyses. This prevents assessment of how evidence across the outcomes was evaluated. Planning illustrations, which use specified assumptions, should remain distinct from observed results and should not be interpreted as observed power.

These features make the record a useful example of why statistical interpretation depends on transparent results, denominators, analysis methods, and design—not only on a stated clinical objective or a named outcome measure.

15. 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 are specific to the information and design recorded for this trial. The study was single-group, open-label, and had no concurrent comparator. It therefore cannot provide a randomized comparison, and any within-group change would be difficult to attribute specifically to the intervention. Masking is listed as none.

The total enrollment was 18. The primary endpoint population excluded people discontinued because they received less than 2 weeks of treatment, but the number meeting that definition is not reported in the registry record. The endpoint denominator and the handling of missing measurements are also not reported. Consequently, the relationship between enrollment and the analyzed population cannot be established.

Most importantly for interpretation, the primary mean change and standard deviation are not reported in the registry record, and no statistical analyses are reported. The secondary outcome results are also absent. Without estimates and uncertainty measures, neither the magnitude nor precision of symptom change can be judged. The record does not report a multiplicity strategy, analysis model, or sample-size justification.

The study description identifies a 10-week, 2-phase treatment trial, but the phases are not defined in the registry record. The treatment description states that atomoxetine could be given up to 120 mg/day, with titration over four weeks based on clinical response and observed side-effects; the description is incomplete, so additional treatment details cannot be established. The registry also does not report the death count. These omissions constrain interpretation of both outcome and safety information.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility — NCT00953862.
• Registry record last updated 2016-03-28; status last verified 2016-03.
• Results first posted 2016-03-28.
• 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.

19. Record Summary

The registry record describes a completed, 10-week, open-label, single-group trial of atomoxetine in adults with ADHD and substance use disorder in a residential treatment facility. Enrollment was 18. The primary endpoint was change in AISRS score from baseline to week 10 among treated participants not discontinued due to receiving less than 2 weeks of treatment.

The record lists two secondary symptom or severity outcomes. It does not report the primary or secondary outcome estimates, standard deviations, statistical analyses, missing-data methods, or multiplicity approach. For safety, 0 of 18 participants at risk had a serious adverse event, while 9 of 18 had other adverse events; the death count is not reported in the registry record. The single-group design does not provide a randomized comparator.