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Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits

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ClinicalTrials.gov Identifier: NCT01000064
Recruitment Status : Terminated (unable to meet recruitment goals)
First Posted : October 22, 2009
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Michael G. Tramontana, Vanderbilt University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Traumatic Brain Injury
Attention Deficit Disorder
Interventions Drug: Vyvanse
Procedure: fMRI
Drug: Placebo
Enrollment 22
Recruitment Details  
Pre-assignment Details Of the 22 cases enrolled, five were lost prior to the baseline assessment (moved, unable to contact, no-showed). Two cases were left on hold. Two cases met safety end-point criteria before group assignment. This left 13 individuals who were assigned to groups.
Arm/Group Title Vyvanse First, Then Placebo Placebo First, Then Vyvanse
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Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.

Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.

Drug: Placebo Capsules taken for 42 days.

Drug: Placebo Capsules taken for 42 days.

Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.

Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.

Period Title: Overall Study
Started 7 6
Completed 6 5
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title All Participants
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Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.

Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.

Drug: Placebo Capsules taken for 42 days.

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
1
   7.7%
Between 18 and 65 years
12
  92.3%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
28.85  (8.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
4
  30.8%
Male
9
  69.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).
Hide Description

Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.

CPT-II Preservations represent responses in which reaction time was less than 100 ms; these responses are assumed to be anticipatory, random, or slow/inattentive (i.e., carried over from the previous response) because it is physiologically impossible to respond accurately in so short a time. Higher T-scores, percentiles, and means indicate worse performance.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vyvanse Placebo
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Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.

fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Placebo: Placebo capsules taken every morning for 6 weeks.

fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: ms
50.23  (6.67) 59.76  (17.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vyvanse, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).
Hide Description

Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.

CPT-II Hit Reaction Time (RT) Block Change measures inattention and vigilance. Lower values indicate less slowing in RT as the test progressed. High T-scores indicate decreased vigilance over time.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vyvanse Placebo
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Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.

fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Placebo: Placebo capsules taken every morning for 6 weeks.

fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: t-scores
47.70  (7.47) 54.21  (7.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vyvanse, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II)
Hide Description

Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.

CPT-II Hit Reaction Time (RT) Inter-Stimulus Interval (ISI) Change assesses the ability to adapt to changing inter-stimulus intervals. Inter-stimulus intervals refers to the amount of time between presentation of stimuli. High t-scores indicate that RT increased as the ISI increased; negative values indicate that RT decreased as the ISI increased.

Less Hit RT ISI Change indicates less variability in RT depending on the speed of presentation.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vyvanse Placebo
Hide Arm/Group Description:

Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.

fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Placebo: Placebo capsules taken every morning for 6 weeks.

fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: t-scores
58.08  (17.92) 65.93  (17.61)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vyvanse, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).
Hide Description

Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.

CPT-II Hit Reaction Time (RT) Standard Error (SE) measures inattention. Consistency of response times is measured by the standard error for responses to targets. Higher values indicate a greater amount of inattention.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vyvanse Placebo
Hide Arm/Group Description:

Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.

fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Placebo: Placebo capsules taken every morning for 6 weeks.

fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: ms
54.26  (18.21) 64.04  (15.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vyvanse, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Primary Outcome
Title Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Wechsler Adult Intelligence Scale -- Fourth Edition (WAIS-IV) Digit Span-Backward Subtest.
Hide Description Digit Span repeats strings of digits of increasing length said by the examiner in the same (forward) and in reverse (backward) order. It measures working memory and concentration with a range of scaled scores from 1-19, with higher scaled scores indicating better performance when compared to population norms.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vyvanse Placebo
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Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.

fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Placebo: Placebo capsules taken every morning for 6 weeks.

fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.60  (3.86) 9.40  (4.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vyvanse, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Primary Outcome
Title Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Conners Adult ADHD Rating Scale: Long Form (CAARS:L) "Inattention/Memory Problems" Sub-scale.
Hide Description

The CAARS:L is an assessment tool that prompts an observer to provide valuable information about the client. This instrument is helpful when considering a diagnosis of ADHD or related problem. High scores on the "Inattention/Memory Problems" sub-scale may indicate difficulty in concentration, difficulty planning or completing tasks, forgetfulness, absent-mindedness, and/or being disorganized.

T-scores (M = 50, SD = 10) are used to measure ratings with higher t-scores indicating greater inattention and memory problems. When a t-score is around 60, this indicates greater risk.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vyvanse Placebo
Hide Arm/Group Description:

Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.

fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Placebo: Placebo capsules taken every morning for 6 weeks.

fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: t-scores
51.25  (13.29) 56.33  (12.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vyvanse, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Primary Outcome
Title Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Behaviour Rating Inventory of Executive Function-Adult Version (BRIEF-A) "Organization of Materials" Sub-scale.
Hide Description

The BRIEF-A is a standardized rating scale developed to observe everyday behaviors associated with specific domains of the executive functions in adults ages 18 to 90 years. The "Organization of Materials" scale measures orderliness of work, living, and storage spaces.

T-scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning on the BRIEF-A, with higher scores indicating more difficulty in a particular area.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vyvanse Placebo
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Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.

fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Placebo: Placebo capsules taken every morning for 6 weeks.

fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: t-scores
48.55  (7.95) 56.00  (12.76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vyvanse, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Evaluation of Which Types of Patients Are Most Likely to Benefit From Treatment
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected.
Arm/Group Title All Participants
Hide Arm/Group Description:

Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.

Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.

Drug: Placebo Capsules taken for 42 days.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title The Study Will Utilize fMRI Methods (as Well as Aforementioned Neurobehavioral Measures) to Elucidate Neural Mechanisms of Response.
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the analysis of neurobehavioral assessment data, complications with screening, and limited sample size, the neural mechanisms of response to Vyvanse vs placebo were not significant enough to be measured and compared by fMRI. There is no data from the fMRI to be reported because it was abandoned as an aspect of this study before analysis.
Arm/Group Title Vyvanse First, Then Placebo Placebo First, Then Vyvanse
Hide Arm/Group Description:

Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.

Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.

Drug: Placebo Capsules taken for 42 days.

Drug: Placebo Capsules taken for 42 days.

Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.

Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data were collected for 14 weeks.
Adverse Event Reporting Description Once enrolled, all cases underwent weekly clinical monitoring, drug trial implementation, as well as safety and compliance assessments by a research nurse at the Vanderbilt Clinical Trials Centre (CTC).
 
Arm/Group Title Vyvanse Placebo
Hide Arm/Group Description Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days. Placebo capsule Taken for 42 days.
All-Cause Mortality
Vyvanse Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Vyvanse Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vyvanse Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%) 
Participant withdrawal during study leading to small numbers of participants analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael G. Tramontana
Organization: Vanderbilt University Medical Center
Phone: 615-327-7144
EMail: Michael.Tramontana@Vanderbilt.Edu
Layout table for additonal information
Responsible Party: Michael G. Tramontana, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01000064    
Other Study ID Numbers: TBI 090563
First Submitted: October 15, 2009
First Posted: October 22, 2009
Results First Submitted: December 22, 2015
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017