Trial Outcomes & Findings for Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI) (NCT NCT00702364)

Results Overview

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,

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Post treatment

Results posted on

2014-09-15

Participant Flow

175 people responded to recruitment flier in the Denver area and were screened for eligibility from April 2008 through December 2011. 60 of these enrolled in the study.

60 enrolled participants completed study training; 2 of these withdrew prior to Baseline Assessment. 58 completed baseline assessment and began Placebo Run-in; 3 withdrew prior to randomization. 55 total were randomized.

Participant milestones

Participant milestones
Measure	Atomoxetine 40mg atomoxetine twice a day for 2 weeks atomoxetine :	Placebo Placebo twice a day for two weeks placebo :
Overall Study STARTED	26	29
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atomoxetine n=26 Participants 40mg atomoxetine twice a day for 2 weeks atomoxetine :	Placebo n=29 Participants Placebo twice a day for two weeks placebo :	Total n=55 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=93 Participants	29 Participants n=4 Participants	55 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	23 Participants n=4 Participants	41 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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,

Outcome measures

Outcome measures
Measure	Atomoxetine n=25 Participants 40mg atomoxetine twice a day for 2 weeks atomoxetine :	Placebo n=28 Participants Placebo twice a day for two weeks placebo :
CDR Power of Attention	1262.1744 msec Interval 1209.8949 to 1314.4539	1252.9510 msec Interval 1203.6002 to 1302.3019

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=25 Participants 40mg atomoxetine twice a day for 2 weeks atomoxetine :	Placebo n=28 Participants Placebo twice a day for two weeks placebo :
Stroop Test Interference T-score	56.50 T-score Interval 54.7 to 58.3	55.44 T-score Interval 53.74 to 57.14

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=25 Participants 40mg atomoxetine twice a day for 2 weeks atomoxetine :	Placebo n=28 Participants Placebo twice a day for two weeks placebo :
Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score	28.883 units on a scale Interval 25.746 to 32.021	30.997 units on a scale Interval 28.033 to 33.959

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=25 Participants 40mg atomoxetine twice a day for 2 weeks atomoxetine :	Placebo n=28 Participants Placebo twice a day for two weeks placebo :
Neurobehavioral Functioning Inventory Depression Subscale	27.53 T-score Interval 24.87 to 30.18	29.47 T-score Interval 26.92 to 32.02

Adverse Events

Atomoxetine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cynthia Harrison-Felix, PhD

Craig Hospital

Phone: 303-789-8565

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place