ClinicalTrials.gov lists this study as Recruiting.
Official title: Pilot Trial of Stimulant Treatment to Address Attention and Executive Deficits Among Children With Sickle Cell Disease
Enrollment: 72 participants (Estimated).
What is being studied
Intervention: 5,10-dihydro-5-methylphenazine
Drug: Extended-Release Methylphenidate
Who may be eligible
Ages
8 Years to 17 Years
Sex
All
Healthy volunteers accepted
No
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
* Diagnosed with SCD
* Enrolled on the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP)
* Between the ages of 8.0 and 17.9 years
\*Included if performance measure, rating scale or diagnostic criteria met (within the past 2 years):
* \*Score at or below a Standard Score of 85 (16th percentile) on any 2 out of 4 performance measures:
* NIH Toolbox Flanker
* NIH Toolbox List Sorting
* NIH Toolbox Dimensional Change Card Sort Test (DCST)
* Wechsler Intelligence Scale for Children (WISC) -5/ Wechsler Adult Intelligence Scale (WAIS)-4 Digit Span Forward (DSF)
* \*Score at or above a T Score of 60 (84th percentile) on any 1 out of 2 parent rating scales:
* BRIEF-2 Global Executive
* BASC-3 Attention
* \*Have a documented diagnosis of attention deficit / hyperactivity disorder (any subtype)
* English as the primary language
* Research participant and one caregiver willing to participate and provide consent/assent according to institutional guidelines
* Negative pregnancy test in female participant of childbearing age
Exclusion Criteria:
* Primary language other than English
* Score below the 2nd percentile on the Wechsler Abbreviated Scale of Intelligence (WASI)-2 intelligence quotient (IQ) test (ever)
* Uncontrolled seizures (seizure within the past 6 months)
* Cardiomyopathy or known congenital structural cardiac defects
* Stenotic valvular disease, left coronary artery stenosis, or history of myocarditis or pericarditis
* History of heart arrhythmia including ventricular tachycardia, ventricular fibrillation, supraventricular tachycardia, QT prolongation or concomitant use of medications associated with QT prolongation
* Two or more prior episodes of priapism
* Blood pressure \>95th percentile at the three most recent visits consecutively (i.e., \>95th percentile reading at all three of the most recent hospital visits to St. Jude).
* If blood pressure is \> 95th %ile compared to age-norms on the day of the baseline visit, a repeat blood-pressure reading will be performed both electronically and manually to confirm findings.
* Stimulant medication within the past two weeks
* Severe sensory loss
* Previous adverse reaction to methylphenidate
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
* Currently prescribed another investigational medication.
* Diagnosed with sickle cell-hereditary persistence of fetal hemoglobin (HbSHPFH), sickle cell homozygous C (CC), Hb S/N-Baltimore, or other rare genotypes that would preclude the participant from having the classic symptoms of sickle cell disease
* Currently prescribed any of the following:
* Phenobarbital (anticonvulsant)
* Phenytoin (anticonvulsant)
* Primidone (anticonvulsant)
* Warfarin (anticoagulant)
* Antipsychotic medications
* Selective Serotonin Reuptake Inhibitor (SSRI) medications
* Tricyclic antidepressant (TCA) medications
* Vasopressor medications
Study locations
1 study location is listed.
Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.
Countries: United States
Tennessee, United States: 1
Sample of listed locations
St. Jude Children's Research Hospital — Memphis, Tennessee, 38105, United States — Recruiting
Trial information can change. Confirm current study details with the study team or the registry.
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