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unable to meet recruitment goals
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| Name | Class |
|---|---|
| Shire | INDUSTRY |
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The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help with attention deficits due to traumatic brain injury (TBI). Vyvanse is currently approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact effects this drug may have on attention deficits caused by TBI are not known, but we expect that Vyvanse will be of some help in treating those types of problems as well. The study will utilize functional magnetic resonance imaging (fMRI) methods, as well as neurobehavioral measures, to elucidate neural mechanisms of response.
Symptoms of inattentiveness, impulsivity, and poor persistence have been observed in both children and adults following traumatic brain injury (TBI). These often are among the most prominent symptoms manifested and may contribute to interference in a variety of other functional domains. Although there has been some use of psychostimulant medication to treat TBI-acquired attention deficits, it remains a relatively uncommon clinical practice. This study, by highlighting mechanisms of action, could serve to promote the appropriate use of this type of treatment for the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vyvanse | Active Comparator | Vyvanse capsule, 30-70 mg, each morning for 6 weeks. Placebo capsule each morning for 6 weeks. Brain scans (fMRI) performed at baseline, 6th week visit and 12th week visit. |
|
| Placebo | Placebo Comparator | Vyvanse capsule, 30-70 mg, each morning for 6 weeks. Placebo capsule each morning for 6 weeks. Brain scans (fMRI) performed at baseline, 6th week visit and 12th week visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vyvanse | Drug | 30 mg - 70 mg capsules taken every morning for 6 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II). | 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. | 12 weeks |
| Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II). | 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. | 12 weeks |
| Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II) | 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. | 12 weeks |
| Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Which Types of Patients Are Most Likely to Benefit From Treatment | 12 weeks | |
| The Study Will Utilize fMRI Methods (as Well as Aforementioned Neurobehavioral Measures) to Elucidate Neural Mechanisms of Response. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael G Tramontana, Ph.D. | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vyvanse First, Then Placebo | 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. |
| FG001 | Placebo First, Then Vyvanse | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II). | 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. | Posted | Mean | Standard Deviation | ms | 12 weeks |
|
Adverse event data were collected for 14 weeks.
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vyvanse | Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days. |
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Participant withdrawal during study leading to small numbers of participants analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael G. Tramontana | Vanderbilt University Medical Center | 615-327-7144 | Michael.Tramontana@Vanderbilt.Edu |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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| fMRI |
| Procedure |
Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit. |
|
|
| Placebo | Drug | Placebo capsules taken every morning for 6 weeks. |
|
| 12 weeks |
| 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. | 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. | 12 weeks |
| 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. | 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. | 12 weeks |
| 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. | 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. | 12 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Placebo: Placebo capsules taken every morning for 6 weeks. fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit. |
|
|
|
| Primary | Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II). | 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. | Posted | Mean | Standard Deviation | t-scores | 12 weeks |
|
|
|
|
| Primary | Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II) | 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. | Posted | Mean | Standard Deviation | t-scores | 12 weeks |
|
|
|
|
| Primary | Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II). | 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. | Posted | Mean | Standard Deviation | ms | 12 weeks |
|
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | t-scores | 12 weeks |
|
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | t-scores | 12 weeks |
|
|
|
|
| Secondary | Evaluation of Which Types of Patients Are Most Likely to Benefit From Treatment | No data were collected. | Posted | 12 weeks |
|
|
| Secondary | The Study Will Utilize fMRI Methods (as Well as Aforementioned Neurobehavioral Measures) to Elucidate Neural Mechanisms of Response. | 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. | Posted | 12 weeks |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Placebo | Placebo capsule Taken for 42 days. | 0 | 11 | 0 | 11 |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |