Phase 4 N=17 Randomized Triple-blind Treatment

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

Traumatic Brain Injury · Attention Deficit Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02712996 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcome: Primary: Assessing Severity of Symptoms Associated With Attention-deficit/Hyperactivity Disorder (ADHD) in Children When Using Vyvanse Versus Placebo by Administering the Conners-3 Parent Form — 1.00; 1.76 Z-score

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Lisdexamfetamine (Drug); Placebo (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Vanderbilt University
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Assessing Severity of Symptoms Associated With Attention-deficit/Hyperactivity Disorder (ADHD) in Children When Using Vyvanse Versus Placebo by Administering the Conners-3 Parent Form	1.00; 1.76	—
PRIMARY Assessing Executive Functioning in Children When Using Vyvanse Versus Placebo by Administering the Behavior Rating Inventory of Executive Function (BRIEF) - PARENT	0.51; 1.16	—
PRIMARY Assessing Inattentiveness in Children Using Vyvanse Versus Placebo by Measuring Omissions on the Conners Continuous Performance Task (CPT-II).	0.63; 1.33	—
PRIMARY Assessing Physical Symptoms in Children Using Vyvanse Versus Placebo by Measuring Anxiety on the Revised Child Manifest Anxiety Scale (RCMAS)	0.12; -0.23	—
PRIMARY Assessing Total Symptoms in Children Using Vyvanse Versus Placebo by Measuring Anxiety on the Revised Child Manifest Anxiety Scale (RCMAS)	-0.3; -0.56	—
PRIMARY Assessing Attention Problems in Children Using Vyvanse Versus Placebo by Measuring Symptoms on the Child Behavior Checklist (CBCL)	0.88; 1.37	—
PRIMARY Assessing Anxiety-Depression Problems in Children Using Vyvanse Versus Placebo by Measuring Symptoms on the Child Behavior Checklist (CBCL)	0.44; 0.76	—
PRIMARY Assessing Inhibitory Control in Children When Using Vyvanse Versus Placebo Utilizing the Inhibit Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS	-0.05; 0.42	—
PRIMARY Assessing Ability to Tolerate Change in Children When Using Vyvanse Versus Placebo by Utilizing the Shift Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS	0.33; 1	—
PRIMARY Assessing Ability to Begin Tasks in Children When Using Vyvanse Versus Placebo by Utilizing the Initiate Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS	0.64; 1.23	—
PRIMARY Assessing Representational Memory in Children When Using Vyvanse Versus Placebo by Utilizing the Working Memory Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS	0.96; 1.69	—
PRIMARY Assessing Task-oriented Monitoring in Children When Using Vyvanse Versus Placebo by Utilizing the Monitor Subscale on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS	0.34; 0.84	—
PRIMARY Assessing Behavior Regulation in Children When Using Vyvanse Versus Placebo by Measuring the Behavior Regulation Index (BRI) on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS	-0.04; 0.48	—
PRIMARY Assessing Cognitive Regulation in Children When Using Vyvanse Versus Placebo by Measuring the Cognitive Regulation Index (CRI) on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS	0.68; 1.33	—
PRIMARY Assessing Emotion Regulation in Children When Using Vyvanse Versus Placebo by Measuring the Emotion Regulation Index (ERI) on the Behavior Rating Inventory of Executive Function (BRIEF) - PARENTS	0.35; 0.94	—
PRIMARY Assessing Hyperactivity in Children When Using Vyvanse Versus Placebo by Administering the Conners-3 Parent Form	0.075; 0.71	—
PRIMARY Assessing Executive Functioning in Children When Using Vyvanse Versus Placebo by Administering the Conners-3 Parent Form	0.97; 1.79	—
SECONDARY Assessing Executive Functioning in Children When Using Vyvanse Versus Placebo by Administering the Behavior Rating Inventory of Executive Function (BRIEF) - CHILD SELF REPORT	0.66; 0.59	—
SECONDARY Assessing Working Memory and Concentration in Children Using Vyvanse Versus Placebo by Measuring Performance on the Digit Span Subtest of the Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V)	-0.27; -0.29	—
SECONDARY Assessing Sustained Attention and Response Inhibition in Children Using Vyvanse Versus Placebo by Measuring Reaction Time (RT) Standard Error (SE) on the Conners Continuous Performance Task (CPT-II).	0.14; 0.57	—
SECONDARY Assessing Sustained Attention and Response Inhibition in Children Using Vyvanse Versus Placebo by Measuring RT Inter-Stimulus Interval (ISI) on the Conners Continuous Performance Task (CPT-II).	—	—
SECONDARY Assessing Sustained Attention and Response Inhibition in Children Using Vyvanse Versus Placebo by Measuring Hit Reaction Time (RT) Block Change on the Conners Continuous Performance Task (CPT-II).	0.75; 1.19	—
SECONDARY Assessing Sustained Attention and Response Inhibition in Children Using Vyvanse Versus Placebo by Measuring Perseverations on the Conners Continuous Performance Task (CPT-II).	1.02; 0.86	—

Summary

The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help children ages 6-16 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 adults with attention deficits caused by TBI have been investigated prior. The exact effects this drug may have on children with attention deficits caused by TBI are not known, but the investigators expect that Vyvanse will be of some help in treating this population as well.

Eligibility Criteria

Inclusion Criteria

Males and females ages 6 to 16
Traumatic brain injury rated as mild/moderate/severe (based on Glasgow Coma Scale, estimated posttraumatic amnesia, indications of intracranial injury on CT scan, etc.)
Sustained 2-36 months earlier
Considered to be neurologically stable (absence of post-acute symptoms of confusion, disorientation, etc.)
Persistent (> 2 months) problems with focused or sustained attention
Problems with attention/concentration rated as among the most prominent cognitive changes
Accompanying features may include diminished arousal/speed/stamina and/or hyperactivity/impulsivity symptoms.

Exclusion Criteria

Cases with primarily penetrating head trauma
Pre-injury history of diagnosed ADHD
Pre-injury history of other neurodevelopmental disorders including intellectual disabilities, major communication disorders, autism spectrum disorder
Unstable or serious psychiatric conditions, such as psychotic symptoms. Concurrent problems with depression, anxiety, or post-traumatic stress disorder may be present but are judged to be stable and not so severe as to require pharmacologic treatment
Treatment with psychotropic medication(s), including psychostimulant(s) within the last 6 months, but eligible thereafter
Lifetime history of stimulant abuse or dependence. Other (non-stimulant) substance abuse within the past 6 months.
Tics or other contraindications for psychostimulant use including cardiovascular disease, uncontrolled hypertension or hyperthyroidism, glaucoma, agitation, use of an monoamine oxidase (MAO) inhibitor within the past six weeks. Pregnancy would also be an exclusion for girls of childbearing age.
Estimated intelligence quotient (IQ) < 70
Sensory and/or motor impairment(s) seriously limiting testing options
Neurological conditions including uncontrolled epilepsy, degenerative disorders, brain tumor, or stroke
Physical condition affecting arousal, activity level, or stamina including uncontrolled thyroid dysfunction, severe or symptomatic anemia, autoimmune or metabolic disorders, untreated moderate/severe sleep apnea, etc.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02712996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.