NCT01109849
Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
See it on ClinicalTrials.gov ↗230 people
26.5%
73.5%
61 womenmiddle line = equal numbers169 men
- Phase
- PHASE3
- Paid for by
- Florida International University
- Finished
- 2016-04
- Health conditions
- ADHD, Growth
- Who could join
- Anyone
- Ages
- 5 Years – 12 Years
- Average age
- mean 8.23 years
- Age 65+
- Not reported
- Weight (BMI)
- Not reported
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- White 87.8% · Black / African American 9.6% · More than one race 1.3% · American Indian / Alaska Native 0.4% · Asian 0.4% · Native Hawaiian / Pacific Islander 0.4% · Not reported 0%
Women left out
- Age limit under 65
Older women were turned away, even though they often take this medicine.
“Maximum age: 12 Years.”
- Weight limit (BMI)
Women with a higher (or lower) body weight were turned away.
“children whose Body Mass Index is very low (too light for safe use of stimulant medication) or is too high (overweight so not suitable for weight promotion treatments)”
- No kidney or liver problems
Women with kidney or liver problems were turned away.
“…ory of other medical problems that could impact appetite or weight such as hypothyroidism, diabetes mellitus, liver or renal disease. Also, children using prescription medication that can significantly impact appetite or weight are excluded”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“…ith a history of other medical problems for whom psychostimulant treatment may involve considerable risk including cardiac arrhythmias, hypertension, Tourette's Disorder or history of severe tic exacerbations secondary to stimulant exposure”
- No diabetes
Women with diabetes were turned away.
“…ory of other medical problems that could impact appetite or weight such as hypothyroidism, diabetes mellitus, liver or renal disease. Also, children using prescription medication that can significantly impact appetite or weight are excluded”
- No seizures
Women with epilepsy or past seizures were turned away.
“children who have a history of seizures or other neurological problems and are taking medication to prevent seizures as stimulants could worsen seizures”
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“children with a history of other medical problems for whom psychostimulant treatment may involve considerable risk including cardiac arrhythmias, hypertension, Tourette's Disorder or history of severe tic exacerbations secondary to stimulan…”
Study titles and rules are shown in their original English.