Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)
NCT00702364, Not applicable, Completed, Craig Hospital; results first posted 2014-09-15
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI) | ClinicalTrials.gov |
| NCT number | NCT00702364 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Craig Hospital | ClinicalTrials.gov |
| Conditions | Traumatic Brain INjury | ClinicalTrials.gov |
| Interventions | atomoxetine, placebo | ClinicalTrials.gov |
| First posted | 2008-06-20 | ClinicalTrials.gov |
| Last updated | 2014-09-15 | ClinicalTrials.gov |
| Results first posted | 2014-09-15 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | CDR Power of Attention | Post treatment | Cognitive Drug Research (CDR) Computerized Cognitive Assessment System \[19\] is comprised of a battery of computer-controlled tasks administered on a laptop computer with parallel forms of the tests being presented on each testing session. The Power of Attention factor of the CDR was selected as the primary outcome measure because of its strong psychometric properties in other drug studies with cognitively compromised populations. Instead of utilizing a t-test to compare treatment and control groups, treatment and control groups for both primary and secondary outcomes were compared utilizing an analysis of covariance (ANCOVA) model in which repeat baseline measures taken on each respective outcome served as a covariate. This method controls for any differences that may exist between the groups at baseline. Model assumptions for conducting an ANCOVA were investigated for all primary and secondary analyses, where no violations of model assumptions were detected. Additionally, | ClinicalTrials.gov |
| Primary | Stroop Test Interference T-score | Post treatment | The Stroop Color and Word Test is frequently used to study deficits of attention and executive function in individuals with TBI, and has adequate test-retest reliability. At each administration, the following scores were obtained, Word Reading, Colour Naming and Interference. Raw scores were converted to demographically-adjusted T-scores using Golden and Freshwater norm. | ClinicalTrials.gov |
| Primary | Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score | Post treatment | The Adult ADHD Self-Report Scale (ASRS-v1.1) is a self-report questionnaire that consists of questions involving the 18-items of the The Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV- Text Revision (TR) criteria for ADHD that rate symptoms on a Likert scale ranging from 0-4 based on the frequency of symptoms ("never", "rarely", "sometimes", "often", and "very often"). A previous study of the ASRS found the self-report to be both valid (Cronbach's alpha =.88) and reliable (ICC=.84). Scores on the 18 items were summed for a total ASRS score. | ClinicalTrials.gov |
| Secondary | Neurobehavioral Functioning Inventory Depression Subscale | Post treatment | Neurobehavioral Functioning Inventory (NFI) was developed as a clinical and research tool to quantify a variety of post-injury behaviours and symptoms characteristic of neurologic disability and encountered in daily life. The inventory is comprised of 76 items organized into six analytically derived factor scales: Depression, Somatic, Memory/Attention, Communication, Aggression, and Motor. Respondents are asked to rate items as occurring "never", "rarely", "sometimes", "often", or "always". Using the standardized scoring procedures outlined in the NFI Manual, T-scores were calculated for the Depression sub-scale. Lower T-score indicates less depressive symptomotology. | ClinicalTrials.gov |
Outcomes 4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | CDR Power of Attention | Post treatment | msec | MEAN | ClinicalTrials.gov | |
| PRIMARY | Stroop Test Interference T-score | Post treatment | T-score | MEAN | ClinicalTrials.gov | |
| PRIMARY | Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score | Post treatment | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | Neurobehavioral Functioning Inventory Depression Subscale | Post treatment | T-score | MEAN | ClinicalTrials.gov |
Results by group 8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| CDR Power of Attention | Atomoxetine | 1262.1744 | 95% Confidence Interval 1209.8949 to 1314.4539 | msec | ClinicalTrials.gov | |
| CDR Power of Attention | Placebo | 1252.9510 | 95% Confidence Interval 1203.6002 to 1302.3019 | msec | ClinicalTrials.gov | |
| Stroop Test Interference T-score | Atomoxetine | 56.50 | 95% Confidence Interval 54.70 to 58.30 | T-score | ClinicalTrials.gov | |
| Stroop Test Interference T-score | Placebo | 55.44 | 95% Confidence Interval 53.74 to 57.14 | T-score | ClinicalTrials.gov | |
| Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score | Atomoxetine | 28.883 | 95% Confidence Interval 25.746 to 32.021 | units on a scale | ClinicalTrials.gov | |
| Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score | Placebo | 30.997 | 95% Confidence Interval 28.033 to 33.959 | units on a scale | ClinicalTrials.gov | |
| Neurobehavioral Functioning Inventory Depression Subscale | Atomoxetine | 27.53 | 95% Confidence Interval 24.87 to 30.18 | T-score | ClinicalTrials.gov | |
| Neurobehavioral Functioning Inventory Depression Subscale | Placebo | 29.47 | 95% Confidence Interval 26.92 to 32.02 | T-score | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Atomoxetine | 26 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo | 29 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Atomoxetine | 24 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo | 25 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Atomoxetine | 2 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo | 4 | ClinicalTrials.gov |
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Atomoxetine | ClinicalTrials.gov | ||
| Total, all-cause mortality | Placebo | ClinicalTrials.gov | ||
| Total, other adverse events | Atomoxetine | 0 | 26 | ClinicalTrials.gov |
| Total, other adverse events | Placebo | 0 | 29 | ClinicalTrials.gov |
| Total, serious adverse events | Atomoxetine | 0 | 26 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo | 0 | 29 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Atomoxetine vs Placebo: serious adverse events | Trial comparisons |
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)